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

FLUIDDA

Status and phase: Terminated; Phase 2

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Radiation: HRCT scan; Drug: Placebo of Roflumilast; Drug: Roflumilast

Study type: Interventional

Funder types: Industry

Identifiers

NCT02451540

FLUI-2014-134

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

13 participants in 2 patient groups, including a placebo group

Roflumilast

Active Comparator group

Description:

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

Treatment:

Drug: Roflumilast

Radiation: HRCT scan

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo of Roflumilast

Radiation: HRCT scan