COPD = Chronic Obstructive Pulmonary Disease MedDRA version: 14.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
FluidDA nv
Eligibility
Sex/Gender
All
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the possible use of CT based Functional Respiratory Imaging on the phenotyping of severe COPD patients after a 6month treatment with Daxas®.;Secondary Objective: Secondary outcome variables are health related quality of life, lung function tests and exercise tolerance.;Primary end point(s): Phenotyping of severe COPD patients, after 6 month treatment with Daxas®, with use of functional respiratory imaging. ;Timepoint(s) of evaluation of this end point: October 2012 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Belgium
Contacts
Public ContactJan De Backer
FluidDA nv
Outcome results
None listed