A study to assess the effect of inhaled QVA149 on lung function and gas exchange in patients with moderate to severe COPD
- Conditions
- Chronic obstructive pulmonary disease (COPD)MedDRA version: 20.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2013-004461-13-GB
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 31
- 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
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 14
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess global ventilated lung volume after treatment with QVA149 compared to placebo;<br> Secondary Objective: - To assess regional lung ventilated volume after treatment with QVA149 compared to placebo<br> - To assess gas trapping and collateral ventilation with regional mapping of delayed ventilation during breath hold after treatment with QVA149 compared to placebo<br> - To evaluate physiologic measures of lung function after treatment with QVA149 compared to placebo to provide a measure of assay sensitivity for this study<br> - To assess small airway function after treatment with QVA149 compared to placebo<br> ;Primary end point(s): Global lung ventilation volume;Timepoint(s) of evaluation of this end point: After 8 days of treatment with QVA149
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): - MRI to assess regional ventilation defects and to measure pulmonary perfusion<br> - Collateral ventilation with regional mapping of delayed ventilation during breath hold MRI lung imaging<br> - Spirometry to assess FEV1, FVC, FEV1/FVC ratio.<br> - Lung Clearance Index<br> ;Timepoint(s) of evaluation of this end point: After 8 days of treatment with QVA149