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

NCT ID: NCT02451540

Last Updated: 2018-03-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2017-08-31

Brief 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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Roflumilast

Patient will take Roflumilast (500 micrograms) once a day for 3 months. A HRCT scan will be taken at baseline and after 3 months of treatment

Group Type: ACTIVE_COMPARATOR

HRCT scan

Intervention Type: RADIATION

HRCT scan of thorax, at baseline and after 3 months

Roflumilast

Intervention Type: DRUG

Roflumilast, once a day in the morning during 3 months

Placebo

Patient will take the Placebo of Roflumilast once a day for 3 months. A HRCT scan will be taken at baseline and after 3 months.

Group Type: PLACEBO_COMPARATOR

HRCT scan

Intervention Type: RADIATION

HRCT scan of thorax, at baseline and after 3 months

Placebo of Roflumilast

Intervention Type: DRUG

Placebo, once a day in the morning during 3 months

Interventions

HRCT scan

HRCT scan of thorax, at baseline and after 3 months

Intervention Type: RADIATION

Placebo of Roflumilast

Placebo, once a day in the morning during 3 months

Intervention Type: DRUG

Roflumilast

Roflumilast, once a day in the morning during 3 months

Intervention Type: DRUG

Other Intervention Names

Placebo; Daxas

Eligibility 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)

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

FLUIDDA nv

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wilfried De Backer, M.D., M.S.

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Antwerp

Locations

University Hospital of Antwerp

Edegem, Antwerp, Belgium

Countries

Belgium

Other Identifiers

FLUI-2014-134

Identifier Type: -

Identifier Source: org_study_id