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

NCT ID: NCT04122547

Last Updated: 2019-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Exacerbation Copd Bronchiectasis Lung Function Decreased

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Roflumilast

Roflumilast 500 microgram one tab oral per day

Group Type ACTIVE_COMPARATOR

Roflumilast

Intervention Type DRUG

Active drug

Placebo

One tablet oral per day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo one tablet oral od

Interventions

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Roflumilast

Active drug

Intervention Type DRUG

Placebo

Placebo one tablet oral od

Intervention Type DRUG

Other Intervention Names

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Daxas

Eligibility Criteria

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Inclusion Criteria

* symptomatic Bronchiectasis
* history at least 2 exacerbation last year

Exclusion Criteria

* comorbidity with chronic obstructive pulmonary disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prince of Songkla University

OTHER

Sponsor Role lead

Responsible Party

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Siwasak Juthong

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kanung Saejiam, MS

Role: STUDY_DIRECTOR

Prince of Songkla University

Locations

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Songklanagarind hospital

Songkhla, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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25132558

Identifier Type: -

Identifier Source: org_study_id

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