Combined Glucocorticoid Adrenergic Therapy For Wheezy Preschool Children (CONjuGATE)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Wheeze
• Intervention / Treatment: Drug: Placebo; Drug: Beclomethasone; Device: Aerochamber Max®; Drug: Beclomethasone and Salbutamol

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3B 6A8
      • Alberta Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: beclomethasone; beclomethasone dipropionate 250mcg per puff per puff (Chiesi metered dose inhaler) via a masked spacer (Aerochamber Max®, Plattsburgh, NY, USA). One puff BID for 14 days. Non-identifiable MDI prepared by Chiesi Farmaceutici Inc.	Drug: Beclomethasone; Other Names: Clenil; Device: Aerochamber Max®; Other Names: Masked Spacer for metered dose inhaler
Active Comparator: beclomethasone and salbutamol; beclomethasone diprionate 250mcg and salbutamol 100mcg per puff (Chiesi metered dose inhaler) via a masked spacer (Aerochamber Max®, Plattsburgh, NY, USA). One puff BID for 14 days. Non-identifiable MDI prepared by Chiesi Farmaceutici Inc.	Device: Aerochamber Max®; Other Names: Masked Spacer for metered dose inhaler; Drug: Beclomethasone and Salbutamol; Other Names: Clenil Compositum
Placebo Comparator: Placebo; placebo (Chiesi metered dose inhaler) via a masked spacer (Aerochamber Max®, Plattsburgh, NY, USA). One puff BID for 14 days. Non-identifiable MDI prepared by Chiesi Farmaceutici Inc.	Drug: Placebo; Device: Aerochamber Max®; Other Names: Masked Spacer for metered dose inhaler

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduce unplanned-symptomatic visits to clinicians	After enrolment is complete

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Children's Hospital of Eastern Ontario

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: November 30, 2014
• First Submitted That Met QC Criteria: December 13, 2014
• First Posted (Estimate): December 18, 2014

Study Record Updates

• Last Update Posted (Estimate): November 15, 2016
• Last Update Submitted That Met QC Criteria: November 11, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Asthma; Randomized Trial; Wheeze; Pre-school aged children
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Albuterol; Beclomethasone
• Other Study ID Numbers: ConRCT1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO