Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 14.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Male and female patients that have signed informed consent and are >/= 40 years of age. •Patients with stable Chronic Obstructive Pulmonary Disease (COPD) according to GOLD 2011. •Patients with a post-bronchodilator Force Expiratory Volume in one second (FEV1) of >/= 30% and =65 years) yes F.1.3.1 Number of subjects for this age range 480
Exclusion criteria
Exclusion criteria: •Patients contraindicated for muscarinic antagonist agents and beta-2 agonists. •Patients with a history of malignancy of any organ system, treated or untreated, within the last five years. •Patients with narrow-angle glaucoma, Benign Prostatic Hyperplasia (BPH) or bladder-neck obstruction or moderate-severe renal impairment or urinary retention. •Patients who had a COPD exacerbation within 6 weeks prior to screening. •Patients who have a respiratory tract infection within 4 weeks prior to screening. •Patients requiring long term oxygen therapy prescribed for more than 12 hour per day. •Patients with a history of asthma. •Patients with an onset of respiratory symptoms, including COPD diagnosis, prior to age 40 years. •Patients with a blood eosinophil count of greater than 600 mm/3 during run-in. •Patients with concomitant pulmonary disease. •Patients with a history of certain cardiovascular co-morbid conditions •Patients with a diagnosis of alpha-1 anti-trypsin deficiency. •Patients with active pulmonary tuberculosis. •Patients in the active phase of a pulmonary rehabilitation programme. •Other protocol-defined exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superiority of QVA149 27.5/12.5 µg b.i.d. compared to monotherapy components, QAB149 27.5 µg b.i.d. and NVA237 12.5 µg b.i.d., in terms of standardized FEV1AUC0-12 at Week 12.;Secondary Objective: Key secondary objective: To demonstrate the superiority of QVA149 27.5/12.5 µg b.i.d. compared to placebo at Week12 in terms of the change in Health Status, based on total score as well as the percentage of patients with clinically significant improvement, as reported by the patients using the SGRQ. Secondary objectives - To evaluate the superiority of QVA149 27.5/12.5 µg b.i.d., QAB149 27.5 µg b.i.d. and NVA237 12.5 µg b.i.d. compared to placebo in terms of standardized FEV1AUC0-12 at Wk 12. - To evaluate the superiority of QVA149 27.5/12.5 µg b.i.d., QAB149 27.5 µg b.i.d. and NVA237 12.5 µg b.i.d. compared to placebo in terms of the following endpoints: -trough FEV1 (mean of 23 h 15 min and 23 h 45 min post morning dose) at Wk 12 -pre-dose trough FEV1 (mean of 15 min and 45 min pre morning dose) at Week 12 -Trough FEV1 (mean of 23 h 15 min and 23 h 45 min post morning dose) after Day1 -FEV1 and FVC at any time point Other secondary objectives listed in the protocol may apply;Primary end point(s): Standardized Forced Expiratory Volume in one second Area Under the Curve (AUC) following 12 weeks of treatment. ;Timepoint(s) of evaluation of this end point: Timeframe : 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1-Total St. George's Respiratory Questionnaire score 2-Trough Forced Expiratory Volume in one second 3-Pre-dose trough Forced Expiratory Volume in one second 4-Transitional Dyspnea Index focal score 5-Number of puffs of rescue medication 6-Daily symptoms score 7-Trough Forced Expiratory Volume in one second 8-Forced Expiratory Volume in one second at any time point 9-Morning symptoms score 10-Evening symptoms scores 11-Forced Vital Capacity at different time points ;Timepoint(s) of evaluation of this end point: Timeframe : 1.2.3.4.5.6.7.9.10.11 : 12 weeks 8 : day 1 | — |
Countries
Argentina, Colombia, Egypt, France, Guatemala, Hungary, Mexico, Panama, Slovakia, Slovenia, United States, Venezuela, Bolivarian Republic of
Contacts
Public ContactPublic Information Desk
Novartis Hungária Kft., Pharma
Outcome results
None listed