Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis

Phase 3

Completed

• Conditions: Bronchiectasis; Exacerbation Copd; Lung Function Decreased
• Interventions: Drug: Placebo; Drug: Roflumilast

• Registration Number: NCT04122547
• Lead Sponsor: Prince of Songkla University

Brief Summary

Roflumilast compare with placebo for decrease infected exacerbation in non-cystic Bronchiectasis

Detailed Description

Efficacy and RCT compare roflumilast vs placebo for 6 months in frequent infectious exacerbation in non-cystic bronchiectasis in Thailand

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2019-10
• Study First Submitted: 2019-10-08
• Study First Submitted QC: 2019-10-09
• Last Update Submitted: 2019-10-09
• Study First Posted: 2019-10-10
• Last Update Posted: 2019-10-10

Recruitment & Eligibility

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

Inclusion Criteria

• symptomatic Bronchiectasis
• history at least 2 exacerbation last year

Exclusion Criteria

• comorbidity with chronic obstructive pulmonary disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	One tablet oral per day
Roflumilast	Roflumilast	Roflumilast 500 microgram one tab oral per day

Primary Outcome Measures

Name	Time	Method
acute deterioration of of bronchiectasis symptoms	6 months	acute dyspnea worsening respiratory of symptoms

Secondary Outcome Measures

Name	Time	Method
Lung functions	6 months	FEV1
Exercise capacity	6 months	6 minute walk distance

Trial Locations

Locations (1)

Songklanagarind hospital; 🇹🇭 Songkhla, Thailand