Determinants Of Oral Corticosteroid Responsiveness in Wheezing Asthmatic Youth

Asthma Clinical Trial

— DOORWAY  

Official title:

Determinants Of Oral Corticosteroid Responsiveness in Wheezing Asthmatic Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02013076
• Other study ID #: CHUSJ
• Status: Completed
• Phase: N/A
• First received: December 11, 2013
• Last updated: July 18, 2014
• Start date: January 2011
• Est. completion date: January 2014

Study information

• Verified date: July 2014
• Source: St. Justine's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1011
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 17 Years

Eligibility

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 ß2-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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
Canada	Children's Hospital of London Health Sciences Centre	London	Ontario
Canada	CHU Sainte-Justine (CHUSJ)	Montreal	Quebec
Canada	Montreal Children's Hospital (MCH)	Montreal	Quebec
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario
Canada	Centre Hospitaliser de l'Université Laval	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
St. Justine's Hospital	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Number of children with vomiting, serious Infection, psychosis, and mood disturbances	Within 7 days of the index ED exacerbation	Yes
Other	Serious Adverse Health Events	Number of children with adverse events requiring hospitalization, prolonged hospitalization, life threatening, other medically important events or associated with significant disability or incapacity	Within 7 days of the index ED exacerbation	Yes
Primary	Hospital admission	Hospital admission or Length of active treatment for 8 or more hours after the oral corticosteroid administration or ED return visit associated with hospital admission within 72 hours after the oral corticosteroid administration or ED return visit associated within 72 hours with length of active treatment for 8 or more hours after the oral corticosteroid administration	72 hours after oral corticosteroids administration	No
Secondary	Length of active treatment in hospital		8 hours after oral corticosteroid administration	No
Secondary	Meeting the severity criteria for admission	Proportion of children with a PRAM score =4 within 4 hours of oral corticosteroid administration	Within 4 hours of oral corticosteroid administration	No
Secondary	PRAM profile in the ED	Area under the curve of the PRAM measured hourly for the time of oral corticosteroid (OCS) until 4 hours after OCS	Within 4 hours of oral corticosteroid administration	No
Secondary	Time to meeting discharge criteria	Time until PRAM score = 3	Within 8 hours of oral corticosteroid administration	No
Secondary	Change in respiratory resistance	Change in respiratory resistance between baseline and disposition will be documented on the MasterScreen Impulse Oscillometry (Cardinal Health Canada, Montreal, Canada) using previously described standardized techniques in cooperative children aged =3 years. (measured in a subset of individuals)	Within 4 hours of oral corticosteroid administration	No
Secondary	Unscheduled visits for asthma	unscheduled visits for asthma as reported by parents and confirmed by medical charts.	Within 7 days of the index ED exacerbation	No
Secondary	Symptom score	Area under the curve of symptoms measured daily on the validated Asthma flare-up diary for children	Within 7 days of the index ED exacerbation	No
Secondary	Duration of asthma symptoms	Duration of symptoms measured daily on the validated Asthma flare-up diary for children	Within 7 days of the index ED exacerbation	No
Secondary	Cumulative reliever use	Cumulative number of puffs of reliever medication as recorded daily on the Asthma flare-up diary for children	Within 7 days of the index ED exacerbation	No
Secondary	Duration of use of rescue ß2-agonists	Duration of use of rescue ß2-agonists as recorded on the Asthma flare-up diary for children	Within 7 days of the index ED exacerbation	No