Chronic obstructive pulmonary disease (COPD) MedDRA version: 20.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Ultibro Breezhaler
Product Name: indacaterol/glycopyrronium bromide
Product Code: QVA149
Pharmaceutical Form: Inhalation powder, hard capsul
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 14
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess global ventilated lung volume after treatment with QVA149 compared to placebo; Secondary Objective: - 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 ;Primary end point(s): Global lung ventilation volume;Timepoint(s) of evaluation of this end point: After 8 days of treatment with QVA149 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 ;Timepoint(s) of evaluation of this end point: After 8 days of treatment with QVA149 | — |
Countries
United Kingdom
Contacts
Public ContactMedica Information Services
Novartis Pharmaceuticals UK Limited
Outcome results
None listed