Evaluation With CT Scan of Possible Changes in Airways After Treatment With Daxas® in Severe Chronic Obstructive Pulmonary Disease Patients

FLUIDDA

Status and phase

Completed

Phase 4

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Radiation: Functional Respiratory Imaging

Drug: Placebo of Roflumilast

Drug: Roflumilast

Study type

Interventional

Funder types

Industry

Identifiers

NCT01480661

2011-004271-36 (EudraCT Number)

FLUI-2011-77

Details and patient eligibility

About

In this study the possible changes in airway geometry and function induced by 6 month oral treatment with Daxas® (roflumilast) will be evaluated. The use of functional respiratory imaging (FRI) on the phenotyping of chronic obstructive pulmonary disease (COPD) patients will be examined. The study population consists of 40 severe COPD patients, global initiative for chronic obstructive lung disease (GOLD) stages III until IV.

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

Enrollment

41 patients

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female patient ≥ 30 years old
Patient with BMI ≥ 20
Written informed consent obtained
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.
Patient should be treated according to GOLD guidelines
COPD patient with GOLD stages III until IV
Patient with smoking history of at least 10 pack-years
Patient takes Spiriva® and a fixed combination of inhaled steroids and long acting beta agonist (LABA) 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
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 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).