Evaluation of the effect of Roflumilast in hyperinflated COPD patients by using Functional Respiratory Imaging.

Phase 1

• Conditions: Chronic obstructive pulmonary disease (COPD); MedDRA version: 17.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-000053-21-BE
• Lead Sponsor: FLUIDDA nv

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-14
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Male or female patient = 30 years old
2. Written informed consent obtained
3. Patient with Body mass index (BMI) = 20
4. 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
5. COPD patient with GOLD stages C and D
6. Patient with a Borg Fatigue score after the 6MWT on screening above 4 to indicate the susceptibility to dynamics hyperinflation
7. Patient with smoking history of at least 10 pack-years
8. Patient takes a combination therapy of LABA/ LAMA at least 6 weeks before visit 1
9. Patient must be able to understand and complete the protocol requirements, instructions, questionnaires and protocol-stated restrictions

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. Pregnant or lactating females
2. Patient with severe immunological diseases and/ or severe acute infectious diseases
3. Patient with heart failure as documented in the medical history or as defined by the investigator during the physical examination performed at visit 1
4. Patient with diagnosis of cancer (except basal cell carcinoma)
5. Patient with a history of depression associated with suicidal ideation or behaviour
6. Patient with moderate or severe hepatic impairment.
7. Patient with lactose intolerance
8. Patient is unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
9. Patient who received inhalation corticosteroids (ICS) within the last 6 weeks prior to the screening visit
10. 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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified