E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
COPD (chronic obstructive pulmonary disease) |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Primary objective: To evaluate the effect of the combination on central and peripheral airway dimensions with Computational Fluid Dynamics (CFD). |
|
E.2.2 | Secondary objectives of the trial |
Secondary to assess the effect of the combination on lung function (spirometry, body plethysmography) and BODE index and to evaluate the safety of this combination. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients with documented COPD based on the following criteria: -Smoking history of at least 10 pack-years -Decreased Tiffeneau index: FEV1/FVC < 0.70 2. Male or female patients aged ≥ 40 years 3. Patients who present -Moderate COPD with an FEV1 between 50 and 80% of predicted (GOLD 2) -Severe COPD with an FEV1 between 30 and 50% of predicted (GOLD 3) -Very severe COPD with an FEV1 lower than 30% of predicted (GOLD 4) 4. Patients will be maintained on stable respiratory medications for 6 weeks prior to screening 5. Patients with a co-operative attitude and ability to be trained to correctly use the pMDI 6. Written informed consent obtained 7. Patients should be treated according to GOLD guidelines, with a deviation for treatment of COPD GOLD 2 patients -FEV1 ≤60% predicted: treatment with inhalation corticosteroids (IHC) allowed. -FEV >60% predicted: IHC treatment allowed if exacerbation occurs after cessation of IHC treatment |
|
E.4 | Principal exclusion criteria |
1. Pregnant or lactating females or females at risk of pregnancy 2. Unstable patients who developed an exacerbation during the last 4 weeks 3. Use of CPAP or BiPAP device 4. Inability to carry out pulmonary function testing 5. Diagnosis of asthma as defined by the current GINA guidelines 6. Patients with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study 7. Patients with a QTc interval (Bazett’s formula) at the screening visit ECG test >450 msec 8. Cancer or any other chronic disease with poor prognosis and /or affecting patient status 9. History of alcohol or drug abuse 10. Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients 11. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study 12. Patients who received any investigational new drug within the last 4 weeks prior to the screening visit 13. Patients treated with any non-permitted concomitant medication |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Effect of delivery treatment of Inuvair in COPD patients |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Last follow-up visit of last subject. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |