Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 15.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Sponsors
Novartis Farmacéutica, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who have signed an Informed Consent Form prior to initiation of any studyrelated procedure. 2. Male and female adults aged ?40 years. 3. Patients with stable COPD according to the current GOLD strategy. 4. Patients with airflow limitation indicated by a post-bronchodilator FEV1 ? 30% and =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG (human Chorionic Gonadotropin) laboratory test. 2. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. Effective contraception methods are described in the protocol3. Patients with Type I or uncontrolled Type II diabetes. 3. Patients with Type I or uncontrolled Type II diabetes. 4. Patients with a history of long QT syndrome or whose QTc measured at Visit 101 (Fridericia method) is prolonged (>450 ms for males and females) and confirmed by a central assessor. These patients should not be re-screened. 5. Patients who have a clinically significant ECG abnormality at Visit 101 or Visit 102. (These patients should not be re-screened) 6. Patients who have a clinically significant laboratory abnormality at Visit 101. 7. Patients with a body mass index (BMI) of more than 40 kg/m2. 8. Patients who have clinically significant renal, cardiovascular (such as but not limited to unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, myocardial infarction), arrhythmia (see below for patients with atrial fibrillation), neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of the efficacy and safety of the study treatment. 9. Patients with paroxysmal (e.g. intermittent) atrial fibrillation are excluded. Patients with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy (i.e., selective beta blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) for at least 6 months may be considered for inclusion. In such patients, atrial fibrillation must be present at Visit 101 and Visit 102 visits with a resting ventricular rate < 100/min. At Visit 101 the atrial fibrillation must be confirmed by central reading. 10. Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof: ? anticholinergic agents ? long and short acting beta-2 agonists ? sympathomimetic amines ? lactose or any of the other excipients of trial medication For the full list of exclusion criteria, please refer to the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superiority of QVA149 27.5/12.5 ?g b.i.d. compared to monotherapy components, QAB149 27.5 ?g b.i.d. and NVA237 12.5 ?g 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 ?g 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 ?g b.i.d., QAB149 27.5 ?g b.i.d. and NVA237 12.5 ?g 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 ?g b.i.d., QAB149 27.5 ?g b.i.d. and NVA237 12.5 ?g 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
Canada, Philippines, Poland, Romania, Spain, Ukraine, United States, Vietnam
Contacts
Public ContactDepartamento Médico (ICRO)
Novartis Farmacéutica, S.A.
Outcome results
None listed