E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic obstructive pulmonary disease (COPD) |
|
E.1.1.1 | Medical condition in easily understood language |
COPD is a chronic condition of the lungs which causes people to suffer from symptoms such as shortness of breath and coughing |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10010952 |
E.1.2 | Term | COPD |
E.1.2 | System Organ Class | 100000004855 |
|
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 |
To assess global ventilated lung volume after treatment with QVA149 compared to placebo |
|
E.2.2 | Secondary objectives of the trial |
- To assess regional lung ventilated volume after treatment with QVA149 compared to placebo
- To assess gas trapping and collateral ventilation with regional mapping of delayed ventilation during breath hold after treatment with QVA149 compared to placebo
- To evaluate physiologic measures of lung function after treatment with QVA149 compared to placebo to provide a measure of assay sensitivity for this study
- To assess small airway function after treatment with QVA149 compared to placebo |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Written informed consent must be obtained before any assessment is performed
- Male and female with COPD aged 40 years and above
- Smokers and ex-smokers who have a smoking history of at least 10 pack years
- Patients with a diagnosis of moderate to severe COPD according to GOLD 2015 criteria. Patients with airflow limitation indicated by a post-bronchodilator FEV1/FVC < 0.70
- Able to communicate well with the investigator, to understand and comply with the requirements of the study |
|
E.4 | Principal exclusion criteria |
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
- Any significant medical condition that in the opinion of the Investigator may compromise patient safety, patient compliance, interfere with evaluations, or preclude completion of the trial
- Patients who have had a lower respiratory tract infection within 6 weeks prior to randomization, or significant illness which has not resolved within two (2) weeks prior to initial dosing
- Patients with concomitant pulmonary disease, e.g., pulmonary tuberculosis
- Patients with a history of asthma
- HbA1c > 8% at screening to identify patients with poorly controlled Type I or Type II diabetes
- Women of child-bearing potential , defined as all women physiologically capable of becoming pregnant
- Patients unable to successfully use a dry powder inhaler device or perform spirometry
- Subjects with contraindications to MRI |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Global lung ventilation volume |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 8 days of treatment with QVA149 |
|
E.5.2 | Secondary end point(s) |
- MRI to assess regional ventilation defects and to measure pulmonary perfusion
- Collateral ventilation with regional mapping of delayed ventilation during breath hold MRI lung imaging
- Spirometry to assess FEV1, FVC, FEV1/FVC ratio.
- Lung Clearance Index |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
After 8 days of treatment with QVA149 |
|
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 | No |
E.6.4 | Safety | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
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 | No |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 13 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 13 |