Comparative efficacy of daily inhaled fluticasone propionate and episodic inhaled combined salmeterol/fluticasone propionate in children with recurrent wheezing

Phase 4

Completed

• Conditions: recurrent wheezing; Efficacy, Daily, Episodic, Inhaled corticosteroids, Recurrent wheezing

• Registration Number: TCTR20180614002
• Lead Sponsor: Queen Sirikit National Institute of Child Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2017-09-30
• Study Start: 2018-06-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1. History of recurrent wheezing at least 3 times/year and at least 2 of 5 symptom patterns tending to be asthma
- Cough or wheeze more than 10 days during upper respiratory tract infection
- Night worsening symptoms, cough or wheeze triggered by exercise and/or laughing and/or crying
- History of atopy such as atopic dermatitis, allergic rhinitis
- First degree relatives with asthma
- Diagnosed asthma by spirometry

Exclusion Criteria

1. Children who have history of using medications for controlling their recurrent wheezing symptoms such as Inhaled corticosteroids and/or leukotriene receptor antagonists before recruitment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of symptom control 6 months Percentage and time to first exacerbation that needed systemic corticosteroids

Secondary Outcome Measures

Name	Time	Method
Growth suppression and safety 6 months Increased height and adverse events