Efficacy of Roflumilast on Exacerbations in Patients With... | NCT04122547

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

NCT04122547

Sponsor

Prince of Songkla University

Status

Completed

Last Update Posted

Oct 10, 2019Actual

Enrollment

40Actual

Phase

Phase 3

Conditions

Exacerbation Copd
Bronchiectasis
Lung Function Decreased

Interventions

Roflumilast
Placebo

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Oct 8, 2019

First Submission Date that Met QC Criteria

Oct 9, 2019

First Posted Date

Oct 10, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 9, 2019

Last Update Posted Date

Oct 10, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Roflumilast	Active Comparator	Roflumilast 500 microgram one tab oral per day	Drug: Roflumilast
Placebo	Placebo Comparator	One tablet oral per day	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Roflumilast	Drug	Active drug	Roflumilast	Daxas

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
acute deterioration of of bronchiectasis symptoms	acute dyspnea worsening respiratory of symptoms	6 months

Secondary Outcomes

Measure	Description	Time Frame
Lung functions	FEV1	6 months
Exercise capacity	6 minute walk distance	6 months

Other Outcomes

Measure	Description	Time Frame
Health related Quality of life	SGRQ scores, score range from 0-80, high score mean more symptoms	6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

symptomatic Bronchiectasis
history at least 2 exacerbation last year

Exclusion Criteria:

comorbidity with chronic obstructive pulmonary disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kanung Saejiam, MS	Prince of Songkla University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Songklanagarind hospital		Songkhla		90110	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001987	Bronchiectasis
D012131	Respiratory Insufficiency

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C424423	Roflumilast

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided