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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT04122547
• Date of registration: 08/10/2019
• Prospective Registration: No
• Primary sponsor: Prince of Songkla University
• Public title: Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis
• Scientific title: Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis: a Randomized Double-blind Placebo-controlled Trial
• Date of first enrolment: January 2015
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT04122547
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Countries of recruitment

Thailand

Contacts

• Name: Kanung Saejiam, MS
• Affiliation: Prince of Songkla University

Key inclusion & exclusion criteria

Inclusion Criteria:

- symptomatic Bronchiectasis

- history at least 2 exacerbation last year

Exclusion Criteria:

- comorbidity with chronic obstructive pulmonary disease



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Exacerbation Copd

Lung Function Decreased

Bronchiectasis

Intervention(s)

Drug: Roflumilast

Drug: Placebo

Primary Outcome(s)

acute deterioration of of bronchiectasis symptoms [Time Frame: 6 months]

Secondary Outcome(s)

Exercise capacity [Time Frame: 6 months]

Lung functions [Time Frame: 6 months]

Secondary ID(s)

25132558

Source(s) of Monetary Support

Please refer to primary and secondary sponsors