Combined Glucocorticoid Adrenergic Therapy For Wheezy Preschool Children

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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02319564

Acronym

CONjuGATE

Enrollment

Registered

2014-12-18

Start date

2016-04-30

Completion date

2016-10-31

Last updated

2016-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wheeze

Keywords

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

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.

Interventions

DRUGBeclomethasone

DRUGBeclomethasone and Salbutamol

DRUGPlacebo

DEVICEAerochamber Max®

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Months to 60 Months

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026