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

Prince of Songkla University

Status and phase: Completed; Phase 3

Conditions: Bronchiectasis; Exacerbation Copd; Lung Function Decreased

Treatments: Drug: Placebo; Drug: Roflumilast

Study type: Interventional

Funder types: Other

Identifiers

NCT04122547

25132558

Details and patient eligibility

About

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

Full description

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• symptomatic Bronchiectasis
• history at least 2 exacerbation last year

Exclusion criteria

• comorbidity with chronic obstructive pulmonary disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Roflumilast

Active Comparator group

Description:

Roflumilast 500 microgram one tab oral per day

Treatment:

Drug: Roflumilast

Placebo

Placebo Comparator group

Description:

One tablet oral per day

Treatment:

Drug: Placebo