Evaluation with CT-scan of possible changes in airways after treatment with Daxas® in severe COPD patients.

Phase 1

Conditions: COPD = Chronic Obstructive Pulmonary Disease
MedDRA version: 14.0Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2011-004271-36-BE

Lead Sponsor: FluidDA nv

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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