Combined Glucocorticoid Adrenergic Therapy For Wheezy Preschool Children

Wheeze Clinical Trial

— CONjuGATE  

Official title:

Randomized Trial Assessing the Effectiveness of Beclomethasone and Combination Beclomethasone and Salbutamol as Compared With Placebo in Preschool Aged Children With Wheeze

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02319564
• Other study ID #: ConRCT1
• Status: Withdrawn
• Phase: Phase 4
• First received: November 30, 2014
• Last updated: November 11, 2016
• Start date: April 2016
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The investigators goal is to conduct a pilot randomized controlled trial (RCT) whose purpose is to determine the feasibility of a randomized trial designed to determine if either inhaled beclomethasone or a combination of inhaled beclomethasone/salbutamol (Clenil Compositum) are superior to placebo in treating pre-school aged children with an acute wheezing episode.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months to 60 Months

Eligibility

Inclusion Criteria:

1. children 12-60 months of age

2. wheeze on auscultation

3. mild respiratory distress as measured by a score of < 3 on the Pediatric Respiratory Assessment Measure (PRAM)

4. discharged home after evaluation by their ED physician.

Exclusion Criteria:

1. treatment with oral or parenteral corticosteroids in the last 14 days

2. treatment with more than 2 doses of inhaled corticosteroids in the previous seven days

3. presence of a severe co-morbidity such as bronchopulmonary dysplasia, cystic fibrosis, congenital heart disease, adrenal disorder or immune deficiency

4. previously enrolled into this study or concurrently enrolled in another intervention trial

5. lack of telephone access or presence of a significant language barrier

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wheeze

Intervention

Drug:
• Beclomethasone

• Beclomethasone and Salbutamol

• Placebo

Device:
• Aerochamber Max®

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Children's Hospital of Eastern Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduce unplanned-symptomatic visits to clinicians		After enrolment is complete	No
Secondary	Reduce the number of days with respiratory symptoms		Will be analyzed 1-2 months after enrolment is complete, looking at the full follow-up period of 21 days	No
Secondary	Reduce the need for rescue salbutamol use		Will be analyzed 1-2 months after enrolment is complete, looking at the full follow-up period of 21 days	No
Secondary	Reduce hospitalization rates of target population		Will be analyzed 1-2 months after enrolment is complete, looking at the full follow-up period of 21 days	No
Secondary	Reduce overall societal health care costs of target population		Will be analyzed 1-2 months after enrolment is complete, looking at the full follow-up period of 21 days	No