Effects of Roxithromycin on Quality of Life and Physiological Outcomes in Bronchiectasis

Phase 3

Completed

• Conditions: Quality of Life; Respiratory Function Tests
• Interventions: Drug: Placebo; Drug: Roxithromycin 300 MG

• Registration Number: NCT04122040
• Lead Sponsor: Prince of Songkla University

Brief Summary

roxithormycin 300 mg per day for 12 weeks could improve quality of life and physiological outcomes in bronchiectasis

Detailed Description

A randomized, double blinded, placebo controlled study was conducted to evaluate the effects of a 12-week administration of roxithromycin 300 mg once daily and a 12-week follow-up period in symptomatic stable bronchiectasis

Study Timeline

• Study Start: 2011-03-01
• Primary Completion: 2011-09-30
• Study Completion: 2011-09-30
• Status Verified: 2019-10
• Study First Submitted: 2019-10-08
• Study First Submitted QC: 2019-10-08
• Study First Posted: 2019-10-10
• Last Update Submitted: 2019-10-10
• Last Update Posted: 2019-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Adverse drug reaction to macrolide Recent exacerbation within 2 weeks History of macrolide therapy within 2 weeks active malignancy and end stage diseases 5. not perform lung function tests Females who were lactating

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	placebo one tablet per day
roxithromycin	Roxithromycin 300 MG	roxithromycin 300 mg oral per day

Primary Outcome Measures

Name	Time	Method
SGRQ scores	for 12 weeks	SGRQ scores

Secondary Outcome Measures

Name	Time	Method
sputum volumes	24 wekse	sputum volume per day
pulmonary function tests	24 weeks	FEV1