Combined Glucocorticoid Adrenergic Therapy For Wheezy Preschool Children

NCT02319564 | Withdrawn Phase 4 DMC

• 1 other identifier: ConRCT1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wheeze

Keywords

Wheeze; Asthma; Randomized Trial; Pre-school aged children

Outcome Measures

Primary Outcomes (1)

• Reduce unplanned-symptomatic visits to clinicians

  After enrolment is complete

Secondary Outcomes (4)

• 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

Study Arms (3)

beclomethasone

ACTIVE COMPARATOR

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; Device: Aerochamber Max®

beclomethasone and salbutamol

ACTIVE COMPARATOR

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.

Drug: Beclomethasone and Salbutamol; Device: Aerochamber Max®

Placebo

PLACEBO COMPARATOR

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®

Interventions

Beclomethasone DRUG

Also known as: Clenil

beclomethasone

Beclomethasone and Salbutamol DRUG

Also known as: Clenil Compositum

beclomethasone and salbutamol

Placebo DRUG

Placebo

Aerochamber Max® DEVICE

Also known as: Masked Spacer for metered dose inhaler

Placebo; beclomethasone; beclomethasone and salbutamol

Eligibility Criteria

• Age: 12 Months - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children 12-60 months of age
• wheeze on auscultation
• mild respiratory distress as measured by a score of \< 3 on the Pediatric Respiratory Assessment Measure (PRAM)
• discharged home after evaluation by their ED physician.

You may not qualify if:

• treatment with oral or parenteral corticosteroids in the last 14 days
• treatment with more than 2 doses of inhaled corticosteroids in the previous seven days
• presence of a severe co-morbidity such as bronchopulmonary dysplasia, cystic fibrosis, congenital heart disease, adrenal disorder or immune deficiency
• previously enrolled into this study or concurrently enrolled in another intervention trial
• lack of telephone access or presence of a significant language barrier

Sponsors & Collaborators

• University of Calgary: lead
• Children's Hospital of Eastern Ontario: collaborator

Study Sites (1)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

MeSH Terms

Conditions

Respiratory Sounds; Asthma

Interventions

Beclomethasone; Albuterol; Metered Dose Inhalers

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Nebulizers and Vaporizers; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Departments of Pediatrics, Pharmacology & Physiology

Study Record Dates

• First Submitted: November 30, 2014
• First Posted: December 18, 2014
• Study Start: April 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 15, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)