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

Primary Purpose

Exacerbation Copd, Bronchiectasis, Lung Function Decreased

Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Roflumilast
Placebo
Sponsored by
Prince of Songkla University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exacerbation Copd focused on measuring Bronchiectasis, roflumilast, exacerbation, lung function

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • symptomatic Bronchiectasis
  • history at least 2 exacerbation last year

Exclusion Criteria:

  • comorbidity with chronic obstructive pulmonary disease

Sites / Locations

  • Songklanagarind hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Roflumilast

Placebo

Arm Description

Roflumilast 500 microgram one tab oral per day

One tablet oral per day

Outcomes

Primary Outcome Measures

acute deterioration of of bronchiectasis symptoms
acute dyspnea worsening respiratory of symptoms

Secondary Outcome Measures

Lung functions
FEV1
Exercise capacity
6 minute walk distance

Full Information

First Posted
October 8, 2019
Last Updated
October 9, 2019
Sponsor
Prince of Songkla University
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1. Study Identification

Unique Protocol Identification Number
NCT04122547
Brief Title
Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis
Official Title
Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis: a Randomized Double-blind Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince of Songkla University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Roflumilast compare with placebo for decrease infected exacerbation in non-cystic Bronchiectasis
Detailed Description
Efficacy and RCT compare roflumilast vs placebo for 6 months in frequent infectious exacerbation in non-cystic bronchiectasis in Thailand

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exacerbation Copd, Bronchiectasis, Lung Function Decreased
Keywords
Bronchiectasis, roflumilast, exacerbation, lung function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Roflumilast
Arm Type
Active Comparator
Arm Description
Roflumilast 500 microgram one tab oral per day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
One tablet oral per day
Intervention Type
Drug
Intervention Name(s)
Roflumilast
Other Intervention Name(s)
Daxas
Intervention Description
Active drug
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo one tablet oral od
Primary Outcome Measure Information:
Title
acute deterioration of of bronchiectasis symptoms
Description
acute dyspnea worsening respiratory of symptoms
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Lung functions
Description
FEV1
Time Frame
6 months
Title
Exercise capacity
Description
6 minute walk distance
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Health related Quality of life
Description
SGRQ scores, score range from 0-80, high score mean more symptoms
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: symptomatic Bronchiectasis history at least 2 exacerbation last year Exclusion Criteria: comorbidity with chronic obstructive pulmonary disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kanung Saejiam, MS
Organizational Affiliation
Prince of Songkla University
Official's Role
Study Director
Facility Information:
Facility Name
Songklanagarind hospital
City
Songkhla
ZIP/Postal Code
90110
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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