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OpenTrials
Completed

NCT Number: NCT04122547

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

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

Completed

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Key information

Conditions

Exacerbation Copd Bronchial Diseases Bronchiectasis Lung Function Decreased Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Songklanagarind hospital

Songkhla, 90110, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • symptomatic Bronchiectasis
  • history at least 2 exacerbation last year

Exclusion criteria

  • comorbidity with chronic obstructive pulmonary disease

Treatment and study plan

Roflumilast

Drug

Active drug

Other names: Daxas

Placebo

Drug

Placebo one tablet oral od

Primary outcomes

  1. acute deterioration of of bronchiectasis symptoms

    Time frame: 6 months

    acute dyspnea worsening respiratory of symptoms

Secondary outcomes

  1. Lung functions

    Time frame: 6 months

    FEV1

  2. Exercise capacity

    Time frame: 6 months

    6 minute walk distance

Other outcomes

  1. Health related Quality of life

    Time frame: 6 months

    SGRQ scores, score range from 0-80, high score mean more symptoms

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 10, 2019
Registry last updated
Oct 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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