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

Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis: a Randomized Double-blind Placebo-controlled Trial

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04122547

Enrollment

Registered

2019-10-10

Start date

2015-01-31

Completion date

2015-12-31

Last updated

2019-10-10

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

Conditions

Bronchiectasis, Exacerbation Copd, Lung Function Decreased

Keywords

Bronchiectasis, roflumilast, exacerbation, lung function

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

Interventions

DRUGRoflumilast

Active drug

DRUGPlacebo

Placebo one tablet oral od

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* symptomatic Bronchiectasis * history at least 2 exacerbation last year

Exclusion criteria

* comorbidity with chronic obstructive pulmonary disease

Design outcomes

Primary

Measure	Time frame	Description
acute deterioration of of bronchiectasis symptoms	6 months	acute dyspnea worsening respiratory of symptoms

Secondary

Measure	Time frame	Description
Lung functions	6 months	FEV1
Exercise capacity	6 months	6 minute walk distance

Other

Measure	Time frame	Description
Health related Quality of life	6 months	SGRQ scores, score range from 0-80, high score mean more symptoms

Countries

Thailand

Outcome results

None listed

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