Clinical Trials Logo
  1. Home
  2. Bronchiectasis
  3. NCT04122547
  4. Details
NCT04122547 Clinical Trial

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

Bronchiectasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04122547
Other study ID # 25132558
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 2015
Est. completion date December 2015

Study information
Verified date October 2019
Source Prince of Songkla University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- symptomatic Bronchiectasis

- history at least 2 exacerbation last year

Exclusion Criteria:

- comorbidity with chronic obstructive pulmonary disease

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Roflumilast
Active drug
• Placebo
Placebo one tablet oral od

Locations
Country Name City State
Thailand Songklanagarind hospital Songkhla

Sponsors (1)
Lead Sponsor Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Other Health related Quality of life SGRQ scores, score range from 0-80, high score mean more symptoms 6 months
Primary acute deterioration of of bronchiectasis symptoms acute dyspnea worsening respiratory of symptoms 6 months
Secondary Lung functions FEV1 6 months
Secondary Exercise capacity 6 minute walk distance 6 months
See also
  Status Clinical Trial Phase
Completed NCT05034900 - Does Addition of Oscillatory Positive Expiratory Pressure (OPEP) Device to a Chest Physiotherapy Program Provide Further Health Benefits in Children With Bronchiectasis? N/A
Recruiting NCT04101448 - Prevalence of Bronchiectasis in COPD Patients
Withdrawn NCT03376204 - Pain Mechanisms in Patients With Bronchiectasis
Completed NCT02550821 - Comparison of Physical Activity Level Between Patients With Bronchiectasis and Healthy Subjects
Completed NCT02656992 - Effects of High Intensity Inspiratory Muscle Training on Exercise Capacity in Patients With Bronchiectasis N/A
Completed NCT02048397 - Pulmonary Rehabilitation Program (PRP) Versus PRP Plus Nutritional Supplementation in Patients With Bronchiectasis N/A
Completed NCT01615484 - Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability N/A
Completed NCT02282202 - Evaluation of Oscillatory Positive Expiratory Pressure (oPEP) in Bronchiectasis and COPD N/A
Recruiting NCT01761214 - Bacteriology and Inflammation in Bronchiectasis N/A
Recruiting NCT02527486 - Seoul National University Airway Registry N/A
Completed NCT01578681 - ELTGOL and Bronchiectasis. Respiratory Therapy N/A
Completed NCT01854788 - 3 Airway Clearance Techniques in Non Cystic Fibrosis Bronchiectasis N/A
Completed NCT00769119 - A Phase II , Placebo-controlled Study to Assess Efficacy of 28 Day Oral AZD9668 in Patients With Bronchiectasis Phase 2
Terminated NCT00524095 - Bronchiectasis in Chronic Obstructive Pulmonary Disease (COPD) Patients: Role of Prophylaxis Phase 2
Completed NCT01117493 - Expert Patient Self-management Programme Versus Usual Care in Bronchiectasis N/A
Recruiting NCT00129350 - Assessment of Heart and Heart-Lung Transplant Patient Outcomes Following Pulmonary Rehabilitation Phase 1
Completed NCT00656721 - Respiratory Mechanics Effects of Flutter Valve in Bronchiectasis Patients N/A
Completed NCT04081740 - Biological Determinants of Sputum Rheology in Chronic Airway Diseases
Enrolling by invitation NCT02546297 - Comparisons of Inhaled LAMA or LAMA+LABA or ICS+LABA for COPD With Bronchiectasis Phase 4
Completed NCT03628456 - Effect of HFCWO Vests on Spirometry Measurements N/A