Clinical trial NCT02451540: Evaluation of the Effect of Roflumilast in Hyperinflated COPD Patients Using Functional Respiratory Imaging
Official title: Placebo Controlled Study to Assess the Effect of Roflumilast in Hyperinflated COPD Patients in Addition to LABA/LAMA Therapy Using Functional Respiratory Imaging.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Pulmonary Disease, Chronic Obstructive
dynamics hyperinflation
Computed Tomography scan
CT scan
Functional Respiratory Imaging
FRI
Roflumilast
PRO
Lead sponsor: FLUIDDA nv
Sponsor class: INDUSTRY
First posted: 2015-05-22
Enrollment: 13
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Changes in Airway volume (iVaw)
timeFrame: At baseline and after 3 months of treatment
measure: Changes in Airway resistance (iRaw)
timeFrame: At baseline and after 3 months of treatment
measure: Changes in Lobe volumes (iVlobes)
timeFrame: At baseline and after 3 months of treatment
measure: Changes in Air trapping
timeFrame: At baseline and after 3 months of treatment
measure: Changes in Internal Lobar Airflow Distribution
timeFrame: At baseline and after 3 months of treatment
measure: Low Attenuation or Emphysema Score
timeFrame: At baseline and after 3 months of treatment
measure: Changes in Blood Vessel Density
timeFrame: At baseline and after 3 months of treatment
measure: Changes in Airway Wall Thickness
timeFrame: 3 months
measure: Aerosol deposition concentrations
timeFrame: At baseline and after 3 months of treatment
Secondary outcomes:
measure: Changes in Spirometry
timeFrame: At baseline and after 3 months of treatment
measure: Changes in Body plethysmography
timeFrame: At baseline and after 3 months of treatment
measure: Changes in Diffusion capacity
timeFrame: At baseline and after 3 months of treatment
measure: Changes in 6MWT
timeFrame: At baseline and after 3 months of treatment
measure: Changes in Patient Related Outcome (PRO)
timeFrame: At baseline and after 3 months of treatment
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University Hospital of Antwerp
state: Antwerp
Study officials:
affiliation: University Hospital of Antwerp
name: Wilfried De Backer, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References: