Evaluation of the Effect of Roflumilast in Hyperinflated COPD Patients Using Functional Respiratory Imaging

• Status: Terminated
• Trial end date: 2017-08-31
• Target enrollment: 0
• Participant gender: All

Summary

In this study the efficacy of Roflumilast in addition to LAMA/LABA therapy will be assessed using Functional Respiratory Imaging.

In total 40 Chronic obstructive pulmonary disease (COPD) patients, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages C and D, who are stable on LABA/LAMA therapy and who are prone to dynamics hyperinflation will be included in this study. To indicate the susceptibility to dynamics hyperinflation patients should have a baseline Borg Fatigue score after the 6-minute walk test (6MWT) above 4.

The patients will be randomized in such a way that 1 out of 2 patients will receive placebo and 1 the active component.

Image parameters will be assessed and the correlation with lung function and health related quality of life will be checked before and after treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FLUIDDA nv

Criteria

Inclusion Criteria:

• Male or female patient ≥ 30 years old

• Written informed consent obtained

• Patient with Body mass index (BMI) ≥ 20

• Female patient of childbearing potential who confirm that a contraception method was used at least 14 days before visit 1 and will continue to use a contraception method during the study

• COPD patient with GOLD stages C and D

• Patient with a Borg Fatigue score after the 6MWT on screening above 4 to indicate the susceptibility to dynamics hyperinflation

• Patient with smoking history of at least 10 pack-years

• Patient takes a combination therapy of LABA/ LAMA at least 6 weeks before visit 1

• Patient must be able to understand and complete the protocol requirements, instructions, questionnaires and protocol-stated restrictions

Exclusion Criteria:

• Pregnant or lactating females

• Patient with severe immunological diseases and/ or severe acute infectious diseases

• Patient with heart failure as documented in the medical history or as defined by the investigator during the physical examination performed at visit 1

• Patient with diagnosis of cancer (except basal cell carcinoma)

• Patient with a history of depression associated with suicidal ideation or behaviour

• Patient with moderate or severe hepatic impairment.

• Patient with lactose intolerance

• Patient is unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.

• Patient who received inhalation corticosteroids (ICS) within the last 6 weeks prior to the screening visit

• Patient who received any investigational new drug within the last 4 weeks prior to the screening visit or twice the duration of the biological effect of any drug (whichever is longer)