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Asthma | Determinants Of Oral Corticosteroid Responsiveness in Wheezing Asthmatic Youth

Asthma research study

What is the primary objective of this study?

The aim of the prospective cohort study is to: (1) document the magnitude of response to oral corticosteroids administered to children presenting to the emergency department with moderate or severe asthma and (2) quantify clinically available potential determinants of the response to corticosteroids, such as age, gender, triggers of the index exacerbation, environmental tobacco smoke (ETS), gene polymorphisms, and their interactions.

Who is eligible to participate?

Inclusion Criteria: - Subject will be eligible if he/she: 1. is aged 1 to 17 years, 2. has not received any oral, IM or IV corticosteroid within the last 5 days? 3. Presents to the hospital emergency department with an acute episode of cough, wheezing and/or dyspnea? 4. Has asthma as defined as one or more of the following 6 criteria: (i) prior diagnosis of asthma made by a physician; OR (ii) prior documented episode of acute cough, wheezing and/or dyspnea with significant response to inhaled β2-agonists or to oral corticosteroids; OR (iii) in a child aged <2 years, 3 or more episodes of cough, wheezing and/or dyspnea, including the index visit; OR (iv) previous lung function tests showing significant reversibility post-bronchodilation (≥12% FEV1 or ≥25% Rrs at 4 to 8 Hz); OR (v) a positive provocation test (PC20 ≤8 mg/mL or Provocation Dose (to increase Rrs by 50% or more (PD50) ≤8 mg/mL), OR (vi) the current episode diagnosed or suspected of asthma by the emergency physician? 5. have moderate or severe airway obstruction, defined as a Paediatric Respiratory Asthma Measure (PRAM) score >3 at baseline, Exclusion Criteria: - Patient will be excluded if : 1. he/she has another chronic respiratory condition (such as bronchopulmonary dysplasia or cystic fibrosis); 2. there is a reasonable suspicion of bronchiolitis or foreign body aspiration; 3. he/she has a prior history of hypersensitivity to salbutamol, ipratropium bromide or oral prednisone/prednisolone; 4. he/she has a relative or absolute contraindication to receiving oral corticosteroids such as recent exposure to varicella or live vaccine in past 14 days, 5. there is confirmed or suspected pregnancy.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Asthma

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Oral corticosteroids (OCS)All patients receive: Prednisone or Prednisolone at 1 mg/kg (in 1 site) or 2 mg/kg (in all other sites) (max. 50 mg); if vomiting prednisone/prednisolone: they receive dexamethasone (0.3 mg/kg, max. 10 mg) 2 to 3 doses of salbutamol within the first hour of therapy according to severity Those with severe exacerbations receive 3 treatments with salbutamol and ipratropium bromide within the initial hour of therapy.

Study Status

Completed

Start Date: January 2011

Completed Date: January 2014

Phase:

Type: Observational

Design:

Primary Outcome: Hospital admission

Secondary Outcome: Length of active treatment in hospital

Study sponsors, principal investigator, and references

Principal Investigator: Francine M Ducharme, MD., M.Sc.

Lead Sponsor: St. Justine's Hospital

Collaborator: Canadian Institutes of Health Research (CIHR)

More information:https://clinicaltrials.gov/show/NCT02013076

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