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NCT04122547 Clinical Trial

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

Bronchiectasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04122547
Other study ID # 25132558
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 2015
Est. completion date December 2015

Study information
Verified date October 2019
Source Prince of Songkla University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- symptomatic Bronchiectasis

- history at least 2 exacerbation last year

Exclusion Criteria:

- comorbidity with chronic obstructive pulmonary disease

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Roflumilast
Active drug
• Placebo
Placebo one tablet oral od

Locations
Country Name City State
Thailand Songklanagarind hospital Songkhla

Sponsors (1)
Lead Sponsor Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Other Health related Quality of life SGRQ scores, score range from 0-80, high score mean more symptoms 6 months
Primary acute deterioration of of bronchiectasis symptoms acute dyspnea worsening respiratory of symptoms 6 months
Secondary Lung functions FEV1 6 months
Secondary Exercise capacity 6 minute walk distance 6 months
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