Determinants Of Oral Corticosteroid Responsiveness in Wheezing Asthmatic Youth

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1011 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Albuterol HFA MDI in Pediatric Participants With Asthma

NCT00577655

Asthma

COMPLETED PHASE3

The Development of Novel Clinical Tests to Diagnose and Monitor Asthma in Preschool Children

NCT02743663

Asthma Wheeze Obstructive Sleep Apnea +2 more

COMPLETED

Reducing the Acute Care Burden of Childhood Asthma on Health Services in British Columbia

NCT01326494

Upper Respiratory Tract Infection Asthma

COMPLETED PHASE4

A Chronic-Dose Safety and Efficacy Study of Albuterol Multi-Dose Dry Powder Inhaler in Pediatric Asthmatics

NCT02126839

Asthma

COMPLETED PHASE3

Improving Adherence to Controller Medication in Children With Asthma

NCT05278000

Asthma in Children Adherence, Medication

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The objective of the large multicentre cohort study is to quantify the response to oral corticosteroids in children aged 1 to 17 years presenting to the ED with a moderate or severe asthma exacerbation.

The main outcome is hospital admission within 72 hours of the oral corticosteroid administration.

Secondary outcomes include the change in Pediatric Respiratory Assessment Measure (PRAM), length of active treatment and other markers of response to therapy in the ED as well as markers of recovery over the next 10 days.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Oral corticosteroids (OCS)

All patients receive:

1. 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. 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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

1 Year

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No