NCT04122547

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
Last Updated

October 10, 2019

Status Verified

October 1, 2019

Enrollment Period

11 months

First QC Date

October 8, 2019

Last Update Submit

October 9, 2019

Conditions

Exacerbation CopdBronchiectasisLung Function Decreased

Keywords

Bronchiectasisroflumilastexacerbationlung function

Outcome Measures

Primary Outcomes (1)

  • acute deterioration of of bronchiectasis symptoms

    acute dyspnea worsening respiratory of symptoms

    6 months

Secondary Outcomes (2)

  • Lung functions

    6 months

  • Exercise capacity

    6 months

Other Outcomes (1)

  • Health related Quality of life

    6 months

Study Arms (2)

Roflumilast

ACTIVE COMPARATOR

Roflumilast 500 microgram one tab oral per day

Drug: Roflumilast

Placebo

PLACEBO COMPARATOR

One tablet oral per day

Drug: Placebo

Interventions

RoflumilastDRUG

Active drug

Also known as: Daxas
Roflumilast
PlaceboDRUG

Placebo one tablet oral od

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • symptomatic Bronchiectasis
  • history at least 2 exacerbation last year

You may not qualify if:

  • comorbidity with chronic obstructive pulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Songklanagarind hospital

Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

BronchiectasisRespiratory Insufficiency

Interventions

Roflumilast

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Kanung Saejiam, MS

    Prince of Songkla University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

October 8, 2019

First Posted

October 10, 2019

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

October 10, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)