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All drugs have potential side effects, but thoughtful use can maximize benefits while minimizing risks. Children should not be considered just small adults regarding drug safety because their growth and development are discordant with their ability to sense and self-report drug side effects. Detecting side effects requires vigilance and education from prescribers to parents, who are tasked with monitoring their child over time. A drug's safety profile is published in the package label after pivotal trials are conducted in relatively small and sometimes narrow segments of the population during the U.S. Food and Drug Administration approval process. Drug safety profiles can change as data from postmarketing reports and long-term monitoring during phase IV trials emerge. As such, prescribers are obligated to maintain current understanding of any changes to drug labels. Discussing potential side effects, monitoring, and when to report concerns can be a time-consuming process during patient encounters. This review offers current information regarding potential side effects of some of the most commonly used medications for allergic conditions, asthma, and atopic dermatitis. This information and discussion will hopefully assist clinicians in their conversations with parents, including advice surrounding prescribing medication to minimize adverse effects, parental monitoring, and documentation.
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Asma , Dermatitis Atópica , Adulto , Estados Unidos , Niño , Humanos , Asma/tratamiento farmacológico , Dermatitis Atópica/tratamiento farmacológico , United States Food and Drug AdministrationRESUMEN
Purpose: The rapid spread of SARS-CoV-2, the virus that is responsible for causing COVID-19, has presented the medical community with another example of when convalescent plasma (CP) is still used today. The ability to standardize CP at the onset of a pandemic is unlikely to exist in a reliable and uniformly reproducible way. We hypothesized that CP of unknown strength given in a serial manner will promote health and reduce mortality in those inflicted with COVID-19. Methods: Participants were given up to 8 CP-units depending on their condition upon entry into the study and their response. Results: 102 out of 117 participants were given CP. The earlier a participant received CP corelated with survival (p = 0.0004). The number of CP-units given, throughout all the clinical severities, was not significant with outcomes, p = 0.3947. A higher number of CP-units given to the severe/critical participants (without biological immunosuppressants or restrictive lung disease) did correlate with survival p = 0.0116 (2.8 vs. 2 units). Lower platelets on admission corelated with mortality. Platelet levels increase correlated with CP infusions p < 0.0001. Conclusion: This study supports the serial use of CP of unknown strength based on clinical response for those infected with COVID-19. The use of 3-4 units of CP was found to be statistically significant for survival for severe and critical participants without restrictive lung disease and chronic biological immunosuppression. Increased platelet levels after CP infusions supports that CP is promoting overall health regardless of outcomes.
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INTRODUCTION: Outdoor air pollution (OAP) contributes to poor asthma outcomes and remains a public health concern in Pittsburgh. The purpose of this study was to determine the prevalence of childhood asthma and its rate of control among Pittsburgh schoolchildren residing near OAP sites. METHODS: Participants were recruited from schools near OAP sites. Asthma prevalence and control were assessed using a validated survey. Demographics and socioeconomic status were collected by survey, BMI was calculated, secondhand smoke (SHS) exposure was assessed by salivary cotinine levels, and OAP was assessed by mobile platform monitoring. Multivariate analysis adjusted for confounders. RESULTS: In 1202 Pittsburgh elementary school students surveyed, 50.9% were female, average age was 8.5 years (SD = 1.9), 52.2% were African American and 60.6% had public health insurance. SHS exposure was relatively high at 33.9%, 17.1% of students were obese, and 70% had exposure to particulate matter (PM2.5) greater than the World Health Organization standard of 10 µg/m3. Overall prevalence of asthma was 22.5% with PM2.5, nitric oxide (NOx), sulfur (S), and zinc (Zn) significantly related to odds of asthma. Among the 270 children previously diagnosed with asthma, 59.3% were not well controlled with PM2.5, black carbon, and silicon (Si) significantly related to odds of uncontrolled asthma. CONCLUSIONS: These results demonstrate that asthma prevalence and poor disease control are significantly elevated in Pittsburgh schoolchildren exposed to high levels of OAP. Future efforts need to focus on primary prevention of asthma by reducing exposure to OAP in at risk populations.
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Contaminantes Atmosféricos , Contaminación del Aire , Asma , Contaminación por Humo de Tabaco , Contaminantes Atmosféricos/efectos adversos , Contaminantes Atmosféricos/análisis , Contaminación del Aire/efectos adversos , Contaminación del Aire/análisis , Asma/epidemiología , Niño , Exposición a Riesgos Ambientales/efectos adversos , Exposición a Riesgos Ambientales/análisis , Femenino , Humanos , Masculino , Material Particulado/análisis , Prevalencia , Contaminación por Humo de Tabaco/efectos adversos , Contaminación por Humo de Tabaco/análisisRESUMEN
Background: Intranasal corticosteroids (INCS) are the cornerstone of treatment for chronic rhinosinusitis. Although INCS are generally considered safe and effective, there is a concern that chronic use may lead to ocular adverse effects. Objective: To assess ocular safety of the exhalation delivery system with fluticasone propionate (EDS-FLU) in patients with chronic rhinosinusitis with nasal polyps. Methods: Ocular safety data were collected during two randomized, double-blind, placebo controlled studies with open-label extensions. Ophthalmologists performed tonometry, slit-lamp, and visual acuity examinations to assess intraocular pressure (IOP) and the presence of cataracts. Ocular examinations were conducted before double-blind treatment, at the end of the 16-week double-blind phase, and at the end of the 8-week open-label phase. The results of pooled data from patients who received EDS-FLU 186 µg (n = 160), EDS-FLU 372 µg (n = 161), and EDS-placebo (n = 161) twice daily are reported here. Results: At the end of the double-blind phase, six patients developed elevated average IOP > 21 mm Hg: two patients (1.2%) in the EDS-placebo group, three patients (1.9%) in the EDS-FLU 186 µg group, and one patient (0.6%) in the EDS-FLU 372 µg group. In addition, 6 of 482 patients developed cataracts: 3 patients in the EDS-placebo group, 2 patients in the EDS-FLU 186 µg group, and 1 patient in the EDS-FLU 372 µg group. At the end of the open-label phase, two additional patients showed IOP > 21 mm Hg and two additional patients developed cataracts. Conclusion: No increased risk of elevated IOP was detected with EDS-FLU; the rate of cataract development was similar to EDS-placebo and to that reported with other INCS.Clinical trials NCT01622569 and NCT01624662,
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Catarata , Pólipos Nasales , Sinusitis , Corticoesteroides/uso terapéutico , Catarata/tratamiento farmacológico , Enfermedad Crónica , Ensayos Clínicos como Asunto , Método Doble Ciego , Espiración , Fluticasona/efectos adversos , Humanos , Pólipos Nasales/tratamiento farmacológico , Sinusitis/tratamiento farmacológicoRESUMEN
OBJECTIVE: Asthma action plans (AAP) are recommended to guide asthma management. Written AAPs (WAAPs) are under-utilized and can be difficult to understand. Our study designed and tested a simplified pictorial AAP (PAAP). We hypothesized that better outcomes would be obtained for youth with the PAAP. METHODS: One hundred and sixty-nine (169) youth (aged 8-17; AAP-naïve) were screened for this pilot, 2-arm randomized controlled trial. Feasibility, usability and preliminary efficacy of PAAP compared to a WAAP, for improving outcomes (inhaled corticosteroid (ICS) adherence, symptom control, AAP knowledge, AAP satisfaction) were assessed quantitatively. Youth received an AAP from their physician after completing baseline measures and completed measures at three additional time points (1-, 3-, and 6-month). RESULTS: Forty-five youth were recruited (PAAP = 22; WAAP = 23). Youth AAP knowledge was higher for the PAAP group compared to the WAAP group (p = .017). ICS adherence did not differ between groups, over time, or based on prescribed dosing; however, for WAAP participants, adherence was lower with a higher daily prescription (4 puffs) relative to a lower dose (p = .006). Symptom control improved with both AAPs, but the change was not statistically significant. Lung function did not change significantly by AAP type or time, and literacy variables were not related significantly to outcomes. Youth satisfaction with AAP improved significantly for the PAAP group compared to the WAAP group (p = .03). CONCLUSIONS: Higher AAP knowledge and satisfaction among youth in the PAAP group suggests that structured education from a physician using a PAAP is beneficial. Intervention and study design insights gained will guide future research.
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Asma , Adolescente , Corticoesteroides/uso terapéutico , Asma/tratamiento farmacológico , Protocolos Clínicos , Humanos , Cumplimiento de la Medicación , Satisfacción PersonalRESUMEN
BACKGROUND: Limited comparative data are available on the impact of systemic corticosteroid (SCS) use in children and adolescents. OBJECTIVE: To determine if asthmatic children and adolescents treated with SCS have a higher likelihood of developing complications versus those not receiving SCS and to examine health care resource utilization (HCRU) in this population. METHODS: A retrospective study of data from children and adolescents with persistent asthma retrieved from the MarketScan database, a large US health claims data set, for the period 2000 to 2017 was performed. Propensity score matching was used to pair patients in the SCS and control cohorts. For complications, SCS subgroups (≥4 or 1-3 annual prescriptions) were compared with asthmatic controls without SCS using logistic regression, and for HCRU, cohorts were compared using negative binomial regression. RESULTS: A total of 67,081 patients were included (SCS: 23,898; control: 43,183). The odds of having a complication were 2.9 (95% confidence interval [CI], 2.5-3.2; P < .001) and 1.6 (95% CI, 1.6-1.7; P < .001) times higher in the ≥4 and 1 to 3 SCS groups, respectively, in the first year of follow-up versus controls. For asthma-related hospitalizations, the incidence rate ratio (IRR) was 6.9 (95% CI, 5.6-8.6) and 3.1 (95% CI, 2.8-3.4) times greater in the ≥4 SCS and 1 to 3 SCS groups, respectively, versus controls; for asthma-related emergency department visits, IRR was 5.0 (95% CI, 4.4-5.6) and 2.9 (95% CI, 2.7-3.0) times greater, respectively, versus controls (all P < .01). CONCLUSION: Children and adolescents receiving SCS for persistent asthma have an increased risk of developing complications and have greater HCRU in the first year of follow-up versus those without SCS exposure.
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Asma , Adolescente , Corticoesteroides/uso terapéutico , Asma/tratamiento farmacológico , Asma/epidemiología , Niño , Hospitalización , Humanos , Aceptación de la Atención de Salud , Estudios RetrospectivosRESUMEN
BACKGROUND: Asthma is an important focus for pediatric health research as management of asthma symptoms is a significant challenge, and morbidity and mortality among youths with asthma remain prevalent. Treatment guidelines for asthma recommend a written asthma action plan (WAAP) that summarizes individualized instructions for daily medication use. However, WAAPs are typically written at a seventh- to ninth-grade reading level, which can be a barrier to young people in understanding their treatment, having confidence in using a WAAP, and engaging with asthma education. OBJECTIVE: Utilizing a feasibility and pilot randomized controlled trial (RCT) design, the objective of the Take Action for Asthma Control study is to test a symptom-based, computer-generated pictorial asthma action plan (PAAP) in comparison with a standard WAAP and assess the feasibility and acceptability of the asthma action plan (AAP) intervention and study procedures. The study has 3 aims: (1) estimate the effect sizes of PAAPs compared with WAAPs on outcomes (eg, AAP knowledge and medication adherence), (2) evaluate feasibility and acceptability of AAP intervention and RCT procedures from the perspectives of key stakeholders, and (3) establish whether parent and youth literacy levels are associated with treatment outcomes. METHODS: This feasibility and pilot RCT is a block randomized, 2-arm, parallel-group clinical trial, lasting 6 months in duration. At baseline, participants will be randomly assigned to receive a PAAP or WAAP generated for them and reviewed with them by their asthma physician. Study procedures will take place over 4 separate time points: a baseline clinic appointment, 1-month telephone follow-up, and 3- and 6-month clinic-based follow-ups. At each time point, data will be collected related to the main outcomes: AAP knowledge, AAP satisfaction, asthma control, pulmonary function, and adherence to daily asthma medication. A sample size of up to 60 participants (aged 8-17 years) will be recruited. Feasibility and acceptability data will be collected via one-to-one qualitative interviews with providers involved in the study and a subgroup of families that participate in the study. RESULTS: Recruitment and data collection began in May 2017 and were completed in October 2018. CONCLUSIONS: This pilot and feasibility study will test the potential efficacy, feasibility, and acceptability of an AAP intervention and study procedures. The findings will inform the design and delivery of a future definitive trial to assess the efficacy of PAAPs versus WAAPs in supporting asthma self-management among children and adolescents. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/11733.
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BACKGROUND: An Asthma Adherence Pathway (AAP) application, which is an Internet application that combines patient and clinician education strategies to promote adherence to asthma therapy, has been developed. OBJECTIVE: The primary objective of this pilot study was to evaluate the effectiveness of the AAP application with electronic adherence monitors on asthma control. Secondary objectives evaluated the effect of AAP and monitors on medication adherence, asthma symptoms, quality of life, psychosocial factors, and barriers to treatment. METHODS: Adult patients with asthma were randomly assigned either to intervention (n = 19) or control (n = 20) groups in this 3-month prospective study, and they completed the Asthma Control Questionnaire (ACQ). Intervention patients completed the AAP software and were given barrier-specific motivational interviewing adherence strategies and a SmartTrack device to monitor mometasone furoate/formoterol (MF/F) use. Clinicians in the interventional group received adherence management training. Interventional patients were given feedback regarding adherence findings at each visit. Treatment adherence was determined by the mean of 4 measures of doses taken over 3 months. Control patients were not monitored for MF/F adherence. RESULTS: The mean MF/F adherence in the intervention group was 81%. The intervention and control groups did not differ on the mean baseline ACQ. Thirteen intervention patients achieved the minimal important difference (defined as an improvement ≥0.5 units on the ACQ) compared with 6 control patients (P = .016). The intervention group showed greater improvement in the ACQ (0.75) than the control group (0.19) representing a moderate-to-large effect size of d = 0.638. CONCLUSIONS: The AAP was effective in promoting adherence and helped to improve asthma control. These findings provide preliminary validation of the AAP model.
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Albuterol/uso terapéutico , Asma/tratamiento farmacológico , Broncodilatadores/uso terapéutico , Intervención basada en la Internet , Cumplimiento de la Medicación , Combinación Furoato de Mometasona y Fumarato de Formoterol/uso terapéutico , Entrevista Motivacional/métodos , Educación del Paciente como Asunto/métodos , Adulto , Anciano , Alergólogos/educación , Asma/fisiopatología , Educación a Distancia , Equipos y Suministros , Femenino , Humanos , Masculino , Persona de Mediana Edad , Proyectos Piloto , Neumólogos/educación , Adulto JovenRESUMEN
BACKGROUND: Large sample sizes are needed for sublingual immunotherapy (SLIT) trials because of inherent data variability secondary to inconsistent allergen exposure. Obtaining large sample sizes for pediatric SLIT trials is challenging, but a Bayesian approach using prior adult data can reduce the necessary sample size. OBJECTIVE: We sought to describe how a Bayesian framework using prior information from adult trials can be used to improve pediatric SLIT clinical development. METHODS: Data were compiled by using a frequentist approach (conventional clinical trial approach independent of prior data) from trials conducted during the clinical development of timothy grass SLIT-tablets. RESULTS: The treatment effect of timothy grass SLIT-tablets was considered similar between pediatric (n = 795) and adult (n = 2299) data pools, with relative total combined symptom plus medication score improvement versus placebo of 21% (95% CI, 11.0% to 30.4%) and 20% (95% CI, 14.6% to 24.4%), respectively. Phleum pratense-specific IgG4 and IgE-blocking factor increased from baseline in both children and adults treated with timothy grass SLIT-tablets. Given the reasonable assumption in similarity of treatment response between adults and children, a Bayesian approach is described to demonstrate rigorous efficacy criteria for pediatric trials incorporating information from prior adult trials and thereby reduce the sample size. CONCLUSIONS: Data support the similarity of efficacy and immunologic changes between children and adults treated with SLIT for allergic rhinoconjunctivitis. Therefore it is appropriate to use data from adult trials to design feasible trials in children, which might reduce unsafe off-label use by promoting more quickly proper labeling of approved products.
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Alérgenos/inmunología , Phleum/inmunología , Comprimidos/administración & dosificación , Administración Sublingual , Adolescente , Adulto , Teorema de Bayes , Método Doble Ciego , Femenino , Humanos , Hipersensibilidad/inmunología , Inmunoglobulina E/inmunología , Inmunoglobulina G/inmunología , Masculino , Inmunoterapia Sublingual/métodosRESUMEN
BACKGROUND: Adults and adolescents were included in 3 phase 3 omalizumab trials in chronic idiopathic urticaria (CIU): ASTERIA I, ASTERIA II, and GLACIAL. OBJECTIVE: To describe the baseline clinical profile of adolescent patients with CIU enrolled in the omalizumab trials to add to the limited literature available on CIU in this population. METHODS: Data for patient demographics, baseline clinical disease characteristics, medical history, and previous CIU medication information (not efficacy assessments) from phase 3 omalizumab trials were pooled and descriptive statistical analyses performed for adolescent (12 to <18 years old) and adult (≥18 years old) subgroups. Inferential analysis was inappropriate, partly because of small sample size in the adolescent subgroup. RESULTS: The pooled population of 975 patients with CIU included 39 adolescents (4.0%). Demographics of adolescents and adults with CIU were similar, but compared with adults, fewer adolescents had positive Chronic Urticaria Index test results. Baseline clinical disease characteristics were also similar between the subgroups, with the number of previous CIU medications slightly lower in adolescents compared with adults. Medical history and existing conditions in adolescents tended to be more allergy than cardiovascular related, and fewer experienced angioedema compared with adults. CONCLUSION: Pooled data indicate differences in baseline demographic and clinical characteristics between adult and adolescent patient subgroups. This finding helps augment our understanding of the clinical profile of CIU in adolescents, but larger-scale studies in this population are warranted. TRIAL REGISTRATION: ClinicalTrials.gov Identifiers: NCT01287117 (ASTERIA I), NCT01292473 (ASTERIA II), and NCT01264939 (GLACIAL).
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Antiasmáticos/uso terapéutico , Omalizumab/uso terapéutico , Urticaria/diagnóstico , Urticaria/tratamiento farmacológico , Adolescente , Adulto , Anciano , Niño , Enfermedad Crónica , Ensayos Clínicos Fase III como Asunto , Comorbilidad , Femenino , Humanos , Inmunoglobulina E/sangre , Inmunoglobulina E/inmunología , Masculino , Persona de Mediana Edad , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de Riesgo , Resultado del Tratamiento , Urticaria/etiología , Adulto JovenRESUMEN
BACKGROUND: Both slowed growth in children and reduced bone mineral density (BMD) are systemic effects of corticosteroids, and there is concern about the degree to which these systemic effects affect growth and BMD. OBJECTIVE: To engage in a data-driven discussion of the effects of inhaled corticosteroids (ICSs) on growth in children and BMD. METHODS: Articles were selected based on their relevance to this review. RESULTS: Studies of ICSs in children in which growth was a secondary outcome have revealed slowed growth associated with low doses of budesonide, fluticasone propionate, and beclomethasone dipropionate. In the study of budesonide, the effect was permanent, and in the study of fluticasone propionate, the effect was long-lasting, but it is unclear whether the effect was permanent. However, the results of studies in which growth was the primary outcome were mixed. Slowed growth was detected in a study of beclomethasone dipropionate; however, slowed growth was not detected in a study of ciclesonide or flunisolide. A decrease in BMD acquisition in children was associated with high doses but not low to medium doses of ICSs. In adults, there was a dose-related effect of ICSs on BMD. Both higher daily dose and larger cumulative dose were associated with increased bone density loss. CONCLUSION: Because of the systemic effects on growth and bone health, children should be monitored for growth using stadiometry every 3 to 6 months and BMD should be monitored yearly in patients being treated with high doses of ICSs.
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Corticoesteroides/administración & dosificación , Corticoesteroides/efectos adversos , Antiasmáticos/administración & dosificación , Antiasmáticos/efectos adversos , Huesos/efectos de los fármacos , Desarrollo Infantil/efectos de los fármacos , Administración por Inhalación , Adulto , Asma/complicaciones , Asma/tratamiento farmacológico , Densidad Ósea/efectos de los fármacos , Niño , Preescolar , Humanos , Resultado del Tratamiento , Adulto JovenRESUMEN
BACKGROUND: Earlier 1-year growth studies that used older inhaled corticosteroid (ICS) formulations consistently showed that ICS, but not intranasal corticosteroids (INCS), produced a small â¼1 cm/y growth effect that appeared to be nonprogressive and noncumulative. Studies that lasted for >1 year showed that such treatment during childhood did not affect final adult height. Collectively, these studies led to the beliefs that (1) the small short-term effect on growth is unimportant, (2) there is no long-term harm, and (3) any small risk is easily outweighed by the benefit. This led to the cavalier use of ICS and INCS in children and approval of some INCS for over-the-counter sales for children as young as 2 years of age. METHODS: Literature search using Pub-Med. RESULTS: More recent studies, with improved scientific designs, have challenged and overturned the earlier beliefs. Moreover, some of the newer ICS formulations have negative, robust growth studies (designed per FDA guidance and detected no growth effect). CONCLUSIONS: This review focused on the new evidence and how it will change the way that we use ICS and INCS in children with allergy and asthma in both clinical practice and research, with a renewed focus on safety. There also are significant implications for future iterations of asthma guidelines. The goal was to identify the proper amount of new concern about ICS and INCS, not to generate undue steroid "phobia."
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Corticoesteroides/administración & dosificación , Estatura/efectos de los fármacos , Administración por Inhalación , Administración Intranasal , Corticoesteroides/farmacología , Corticoesteroides/uso terapéutico , Adulto , Antiasmáticos/administración & dosificación , Antiasmáticos/farmacología , Asma/complicaciones , Asma/tratamiento farmacológico , Niño , Humanos , Medición de RiesgoRESUMEN
Sublingual immunotherapy (SLIT) is a safe and effective treatment for allergic rhinitis (AR) and allergic rhinoconjunctivitis (ARC). The Food and Drug Administration (FDA) in the USA has approved three SLIT tablets for the treatment of AR and ARC in relation to pollen. Specifically, Grastek® and Oralair® are two formulations approved to treat patients suffering with AR/ARC to grass pollen, and Ragwitek™ is a formulation approved to treat patients suffering with AR/ARC to ragweed pollen. Although these approvals provide support for physicians to prescribe SLIT, barriers to prescribing SLIT still remain such as FDA approval for additional formulations, a standard dose and dosing schedule, and cost/insurance coverage. In order to further support the use of SLIT, research is currently being conducted to expand the indication for SLIT to other common comorbidities to AR/ARC. For example, allergic asthma, food allergies, and atopic dermatitis are other diseases which are being explored. The future of SLIT in the USA is unknown; however, education will be necessary for both providers and patients.
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Inmunoterapia Sublingual , Animales , Asma/inmunología , Asma/terapia , Dermatitis Atópica/inmunología , Dermatitis Atópica/terapia , Humanos , Rinitis Alérgica/terapia , Inmunoterapia Sublingual/economía , Inmunoterapia Sublingual/métodos , Resultado del Tratamiento , Estados Unidos , United States Food and Drug AdministrationRESUMEN
OBJECTIVES: To identify the prevalence of asthma, obesity, hypertension, and environmental tobacco smoke (ETS) exposure among youth and provide recommendations for follow-up care. METHODS: This cross-sectional study consisted of 12 health screenings for children between 5 and 17 years of age in various inner city, lower socioeconomic, and predominantly black communities throughout the city of Pittsburgh, PA. The screenings were conducted by pharmacists and student pharmacists from April 2010 to April 2012. Asthma, obesity, hypertension, and ETS screenings were offered at each event. RESULTS: A total of 144 children (50% girls, 89% black, non-Hispanic) were enrolled. Sixteen percent of the study population had a previous diagnosis of asthma; 4% were poorly controlled, and 18% were identified as having potential, undiagnosed asthma. Fifty-three percent were at an unhealthy weight (0.7% underweight, 24.3% overweight, 28.5% obese), 24% had abnormal blood pressure (12.8% prehypertension, 8.5% stage 1 hypertension, 2.8% stage 2 hypertension), and 26% had ETS exposure equivalent to that of smokers (0.7% light smokers, 17.5% smokers, and 7.7% heavy smokers). Overall, 177 specific referrals were made. The incidence of hypertension (P <0.001) and the proportion of ETS equivalent to heavy smokers increased (P = 0.019) with increased weight classification. CONCLUSION: Within this self-selected inner city, predominantly black pediatric population, there were high rates of positive screens for potential asthma, obesity, hypertension, and smoking. Additionally, the risk for high ETS exposure and hypertension increased with increasing weight. This study highlights the importance of pharmacists in disease screening and the need for alternative prevention and management strategies in disparate pediatric populations.
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Asma/diagnóstico , Servicios de Salud del Niño/organización & administración , Servicios Comunitarios de Farmacia/organización & administración , Hipertensión/diagnóstico , Tamizaje Masivo/organización & administración , Obesidad Infantil/diagnóstico , Farmacéuticos/organización & administración , Rol Profesional , Servicios Urbanos de Salud/organización & administración , Adolescente , Negro o Afroamericano , Factores de Edad , Asma/etnología , Asma/terapia , Niño , Preescolar , Estudios Transversales , Atención a la Salud/organización & administración , Femenino , Estado de Salud , Hispánicos o Latinos , Humanos , Hipertensión/etnología , Hipertensión/terapia , Incidencia , Masculino , Obesidad Infantil/etnología , Obesidad Infantil/terapia , Pennsylvania/epidemiología , Valor Predictivo de las Pruebas , Prevalencia , Evaluación de Programas y Proyectos de Salud , Factores de Riesgo , Contaminación por Humo de Tabaco/efectos adversosRESUMEN
BACKGROUND: Chronic rhinosinusitis (CRS) and asthma frequently coexist in children and adults. However, the precise pathophysiologic mechanism of this interaction is still poorly understood, especially in children, owing to the lack of direct measurements of mucosal inflammation in the upper airways. OBJECTIVE: To determine the pathophysiologic mechanism by analyzing the expression of a large array of inflammatory cytokines and chemokines in the sinus and adenoid tissues surgically removed from pediatric patients with CRS refractory to medical management. METHODS: Twenty-eight children 2 to 12 years old diagnosed with CRS with or without asthma and 10 controls were included in this prospective, nonrandomized study. Mucosal expression of 40 inflammatory cytokines was measured with a multiplex assay and was normalized to total tissue protein. RESULTS: Compared with children with CRS and without asthma, children with CRS and asthma had significantly higher sinus levels of tumor necrosis factor-α and adenoid levels of epidermal growth factor, eotaxin, fibroblast growth factor-2, growth-related oncogene, and platelet-derived growth factor-AA. CONCLUSION: The inflammatory response in the upper airway mucosa of children with asthma and CRS was similar, but more severe, compared with children with CRS without asthma. This observation is consistent with the hypothesis that asthma in these patients is caused or exacerbated by severe upper airway disease and supports the concept that treating sinus disease is paramount in the management of chronic asthma in children using, for the first time, direct measurements of airway inflammation in children.
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Asma/fisiopatología , Citocinas/biosíntesis , Mucosa Nasal/inmunología , Senos Paranasales/inmunología , Rinitis/fisiopatología , Sinusitis/fisiopatología , Adenoidectomía , Tonsila Faríngea/inmunología , Tonsila Faríngea/cirugía , Asma/inmunología , Niño , Preescolar , Femenino , Humanos , Inflamación/inmunología , Inflamación/patología , Masculino , Tonsila Palatina/inmunología , Tonsila Palatina/cirugía , Estudios Prospectivos , Rinitis/inmunología , Sinusitis/inmunología , Encuestas y Cuestionarios , TonsilectomíaRESUMEN
BACKGROUND: Inadequate designs and conflicting results from previous studies prompted the US Food and Drug Administration to publish guidelines for the design of clinical trials evaluating the effects of orally inhaled and intranasal corticosteroids on the growth of children. This study conformed to these guidelines to evaluate the effect of triamcinolone acetonide aqueous nasal spray (TAA-AQ) on the growth of children with perennial allergic rhinitis (PAR). METHODS: This randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluated the effect of once-daily TAA-AQ (110 µg) on the growth velocity (GV) of children aged 3-9 years with PAR by using stadiometry at baseline (4-6 months), during treatment (12 months), and at follow-up (2 months). Hypothalamus-pituitary-adrenal (HPA) axis function was assessed by measuring urinary cortisol levels. Details of adverse events were recorded. RESULTS: Of 1078 subjects screened, 299 were randomized, and 216 completed the study (placebo, 107; TAA-AQ, 109). In the primary analysis (modified intent-to-treat: placebo, 133; TAA-AQ, 134), least-squares mean GV during treatment was lower in the TAA-AQ group (5.65 cm/year) versus placebo (6.09 cm/year). The difference (-0.45 cm/year; 95% confidence interval: -0.78 to -0.11; P = .01), although clinically nonsignificant, was evident within 2 months of treatment and stabilized thereafter. At follow-up, the GV approached baseline (6.70 cm/year) in the TAA-AQ group (6.59 cm/year) and decreased slightly in the placebo group (5.89 cm/year vs 6.06 cm/year at baseline). No HPA axis suppression was observed. CONCLUSIONS: By using rigorous Food and Drug Administration-recommended design elements, this study detected a small, statistically significant effect of TAA-AQ on the GV of children with PAR.
Asunto(s)
Estatura/efectos de los fármacos , Rinitis Alérgica Perenne/tratamiento farmacológico , Triamcinolona Acetonida/administración & dosificación , Triamcinolona Acetonida/efectos adversos , Administración Intranasal , Administración Oral , Niño , Preescolar , Método Doble Ciego , Femenino , Humanos , Hidrocortisona/orina , Sistema Hipotálamo-Hipofisario/efectos de los fármacos , Análisis de los Mínimos Cuadrados , Masculino , Sistema Hipófiso-Suprarrenal/efectos de los fármacosRESUMEN
PURPOSE OF REVIEW: Sublingual immunotherapy (SLIT) is indicated for the use in pediatric patients suffering from allergic rhinitis or allergic rhinoconjunctivitis caused by environmental allergens, such as ragweed pollen, grass pollen, and dust mite. This review focuses on recent and relevant studies associated with the use of SLIT for these allergens in children by examining efficacy, safety, and immunological data in comparison to subcutaneous immunotherapy, therapeutic treatments, and placebo. RECENT FINDINGS: In several of the case studies examined in this article, involving mainly grass and dust mite allergic patients, SLIT has been shown to have similar efficacy to subcutaneous immunotherapy. SLIT has been proven as a safer therapy. In comparing the adverse events related to both therapies, SLIT has fewer cases of anaphylaxis and fewer incidents of local reactions of mild-to-moderate severity. In comparison to therapeutic treatments and placebo, SLIT significantly improved symptom and medication scores. In addition to allergic rhinitis and allergic rhinoconjunctivitis, additional uses for SLIT in pediatric patients, such as asthma, atopic dermatitis, and food allergies, are under development. SUMMARY: SLIT treatment is a well tolerated and effective approach to treat allergic rhinitis and allergic rhinoconjunctivitis in pediatric patients. Three SLIT tablets are currently approved by the US Food and Drug Administration to treat grass and ragweed allergies. The research discussed in this review will further the knowledge of physicians searching for an alternative treatment for their pediatric patients.
Asunto(s)
Alérgenos/uso terapéutico , Conjuntivitis Alérgica/terapia , Rinitis Alérgica/terapia , Inmunoterapia Sublingual/métodos , Alérgenos/inmunología , Niño , Preescolar , Conjuntivitis Alérgica/inmunología , Conjuntivitis Alérgica/patología , Femenino , Humanos , Lactante , Masculino , Ensayos Clínicos Controlados Aleatorios como Asunto , Rinitis Alérgica/inmunología , Rinitis Alérgica/patologíaRESUMEN
BACKGROUND: The practices and beliefs of the provider specialties that treat allergic rhinoconjunctivitis (ARC) with allergen immunotherapy (AIT) may vary. METHODS: A telephone survey of 500 randomly selected health care practitioners in 7 specialties, conducted in 2012. RESULTS: AIT was provided as a subcutaneous injection (SCIT) by 91% of allergist/immunologists, 54% of otolaryngologists, and 18% to 24% of other specialties. Otolaryngologists were the most frequent providers of sublingual drops of AIT (SLIT; 33%), compared to 2% to 10% of other specialties. AIT was recommended for adults with allergic rhinoconjunctivitis by 100% of allergist/immunologists vs 62% to 84% of the other specialties (p < 0.001). The primary reason for recommending AIT for adults (52%) or children (46%) was that other therapies did not work. Between 48% (nurse practitioners/physician assistants) and 93% (allergist/immunologists) of practitioners always or often decreased symptomatic medications over the course of AIT treatment. Most practitioners in all specialties (82-100%) thought that AIT was appropriate for patients with severe allergy symptoms. Significantly more allergist/immunologists and otolaryngologists than other specialists thought AIT was appropriate for mild allergy symptoms (p < 0.001 and p = 0.004, respectively, vs other specialties). Significantly more allergist/immunologists than other specialists thought that AIT was more effective than symptomatic medications (p < 0.001), could reduce the further development of allergies (p = 0.03), and could prevent the development of asthma. CONCLUSION: SCIT was more frequently provided than SLIT by all the specialties. Otolaryngologists were the most likely to offer SLIT, while very few allergist/immunologists offered SLIT. Allergist/immunologists differed from other specialties in some beliefs about the effectiveness of AIT.
Asunto(s)
Conjuntivitis Alérgica/terapia , Personal de Salud/estadística & datos numéricos , Inmunoterapia/métodos , Pautas de la Práctica en Medicina/estadística & datos numéricos , Rinitis Alérgica/terapia , Adulto , Actitud Frente a la Salud , Niño , Femenino , Conocimientos, Actitudes y Práctica en Salud , Encuestas Epidemiológicas , Humanos , MasculinoRESUMEN
The effect of cetirizine on quality of life (QOL) in subjects with perennial allergic rhinitis (PAR) has been previously evaluated using generic instruments. While generic QOL tools are used across various conditions, disease-specific instruments evaluate the impact of treatment on areas that are affected by that particular condition. This study evaluated the effect of cetirizine on symptom severity and health-related QOL, using a disease-specific instrument, in adults with PAR. This randomized, double-blind, placebo-controlled study was conducted at 15 U.S. centers outside the pollen allergy season. After a 1-week placebo run-in period, qualified subjects aged 18-65 years with PAR were randomized to once-daily cetirizine 10 mg (n = 158) or placebo (n = 163) for 4 weeks. Change from baseline in total symptom severity complex (TSSC) and overall Rhinitis Quality of Life Questionnaire (RQLQ) scores were primary efficacy end points. Cetirizine produced significantly greater improvements in mean TSSC for each treatment week (p < 0.05) and for the entire 4-week treatment period (p = 0.005) compared with placebo. After 4 weeks, cetirizine-treated subjects reported significantly greater overall improvement in RQLQ scores compared with placebo-treated subjects (p = 0.004). After 1 week, cetirizine produced significant improvements in the nasal symptoms, practical problems, and activities RQLQ domain scores compared with placebo (p < 0.05). After 4 weeks, cetirizine-treated subjects reported significant reductions in these RQLQ domain scores and in emotion domain scores compared with placebo-treated subjects (p < 0.05). Cetirizine 10 mg daily produced significant improvements in symptom severity and allergic rhinitis-related QOL compared with placebo in adults with PAR.
Asunto(s)
Antialérgicos/uso terapéutico , Cetirizina/uso terapéutico , Calidad de Vida , Rinitis Alérgica Perenne/tratamiento farmacológico , Adulto , Antialérgicos/administración & dosificación , Antialérgicos/efectos adversos , Cetirizina/administración & dosificación , Cetirizina/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Rinitis Alérgica Perenne/diagnóstico , Índice de Severidad de la Enfermedad , Encuestas y Cuestionarios , Resultado del TratamientoRESUMEN
Previous nationwide surveys of allergies in the United States have focused on nasal symptoms, but ocular symptoms are also relevant. This study determines the effects of ocular and nasal allergies on patients' lives. Telephone surveys of randomly selected U.S. households (the patient survey) and health care providers (provider survey) were conducted in the United States in 2012. Study participants were 2765 people ≥5 years of age who had ever been diagnosed with nasal or ocular allergies and 500 health care providers in seven specialties. Respondents to the patient survey reported a bimodal seasonal distribution of allergy symptoms, with peaks in March to May and September. Nasal congestion was the most common of the symptoms rated as "extremely bothersome" (39% of respondents), followed by red, itchy eyes (34%; p = 0.84 for difference in extreme bothersomeness of nasal and ocular symptoms). Twenty-nine percent of respondents reported that their or their child's daily life was impacted "a lot" when allergy symptoms were at their worst. Workers rated their mean productivity at 29% lower when allergy symptoms were at their worst (p < 0.001 compared with no symptoms). Providers reported that itchy eyes was the symptom causing most patients to seek medical treatment by pediatricians (73%), ophthalmologist/optometrists (72%), and nurse practitioners or physician assistants (62%), whereas nasal congestion was the symptom causing most patients to seek treatment from otolaryngologists (85%), allergist/immunologists (79%), and family medicine practitioners (64%). Ocular and nasal allergy symptoms substantially affected patients' lives and were comparable in their impact.