Chronic Obstructive Pulmonary Disease ( COPD)
Conditions
Interventions
investigational material(s)
Generic name etc : QVA149 (Indacaterol Maleate / Glycopyrronium Bromide)
INN of investigational material :
Therapeutic category code : 225 Bronchodilators
Dosage and Admin
Sponsors
Novartis Pharma K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * Written informed consent must be obtained before any assessment is performed * Patients with stable Chronic Obstructive Pulmonary Disease ( COPD) according to the current GOLD strategy (GOLD 2011) * Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years) * Patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) >= 25 and < 60% of the predicted normal value, and post-bronchodilator FEV1/FVC (Forced Vital Capacity) < 0.70 at day -28. (Post refers to 1 hour after sequential inhalation of 84 micro-g (or equivalent dose) of ipratropium bromide and 400 micro-g of salbutamol) * A documented history of at least 1 COPD exacerbation in the previous 12 months that required treatment with systemic glucocorticosteroids and/or antibiotics * Patients taking stable COPD medication (at least 60 days) prior to day -28 * Patients with an mMRC grade of at least 2 at day -28
Exclusion criteria
Exclusion criteria: *Patients requiring long term oxygen therapy prescribed for >12 hours per day. *Patients who have had a respiratory tract infection within 4 weeks prior to screening Visit 1. *Patients with any history of asthma. *Patients with a history of malignancy of any organ system, treated or untreated, within the past 5 years *Patients with paroxysmal (e.g. intermittent) atrial fibrillation are excluded. *Patients with a diagnosis of alpha-1 anti-trypsin deficiency. *Patients participating in or planning to participate in the active phase of a supervised pulmonary rehabilitation program during the study Other protocol defined inclusion/exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of COPD exacerbations [ Time Frame: 52 weeks ] The rate of COPD exacerbations over 52 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first COPD exacerbation. [ Time Frame: 52 weeks ] The time to the first COPD exacerbation over 52 weeks of treatment. Rate of moderate to severe COPD exacerbations. [ Time Frame: 52 weeks ] The rate of moderate to severe COPD exacerbations during 52 weeks of treatment. Time to first moderate to severe COPD exacerbation. [ Time Frame: 52 weeks ] The time to the first moderate to severe COPD exacerbation over 52 weeks of treatment. The safety (with regard to ECG, laboratory tests, vital signs and adverse events) | — |
Outcome results
None listed