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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02319564
Other study ID # ConRCT1
Secondary ID
Status Withdrawn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Status Withdrawn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


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
See also
  Status Clinical Trial Phase
Withdrawn NCT01868932 - Treating Wheezing in Children With Hypertonic Saline (TWICS) Phase 2
Completed NCT02743663 - The Development of Novel Clinical Tests to Diagnose and Monitor Asthma in Preschool Children
Recruiting NCT02496468 - Pediatric Arm of DZL All Age Asthma Cohort