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

Prince of Songkla University40 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Exacerbation Copd Bronchiectasis Lung Function Decreased

Interventions

RoflumilastDRUG

Active drug

PlaceboDRUG

Placebo one tablet oral od

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * symptomatic Bronchiectasis * history at least 2 exacerbation last year Exclusion Criteria: * comorbidity with chronic obstructive pulmonary disease

Locations (1)

Songklanagarind hospital

Songkhla, Thailand

Outcomes

Primary Outcomes

acute deterioration of of bronchiectasis symptoms

acute dyspnea worsening respiratory of symptoms

Time frame: 6 months

Secondary Outcomes

Lung functions

FEV1

Time frame: 6 months

Exercise capacity

6 minute walk distance

Time frame: 6 months

Data from ClinicalTrials.gov

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