Wheeze Clinical Trial
— CONjuGATEOfficial title:
Randomized Trial Assessing the Effectiveness of Beclomethasone and Combination Beclomethasone and Salbutamol as Compared With Placebo in Preschool Aged Children With Wheeze
Verified date | November 2016 |
Source | University of Calgary |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Withdrawn |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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Alberta Children's Hospital | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary | Children's Hospital of Eastern Ontario |
Canada,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
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