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

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

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

Study Overview

• Status: Completed
• Conditions: Bronchiectasis; Lung Function Decreased; Exacerbation Copd
• Intervention / Treatment: Drug: Roflumilast; Drug: Placebo

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• Thailand
  • Songkhla, Thailand, 90110
    • Songklanagarind hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• symptomatic Bronchiectasis
• history at least 2 exacerbation last year

Exclusion Criteria:

• comorbidity with chronic obstructive pulmonary disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Roflumilast; Roflumilast 500 microgram one tab oral per day	Drug: Roflumilast; Active drug; Other Names: Daxas
Placebo Comparator: Placebo; One tablet oral per day	Drug: Placebo; Placebo one tablet oral od

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Prince of Songkla University

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: October 8, 2019
• First Submitted That Met QC Criteria: October 9, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Actual): October 10, 2019
• Last Update Submitted That Met QC Criteria: October 9, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: lung function; exacerbation; Bronchiectasis; roflumilast
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis
• Other Study ID Numbers: 25132558

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO