Chronic Obstructive Pulmonary Disease MedDRA version: 9.1 Level: LLT Classification code 10009033 Term: Chronic obstructive pulmonary disease
Conditions
Interventions
Product Name: Indacaterol maleate, Glycopyrronium bromide
Product Code: QVA149
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Indacaterol
CAS Number: 435273-74-8
Current Spo
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female adults aged =40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure Patients with moderate to severe stable COPD according to the GOLD Guidelines 2006 Patients who have smoking history of at least 10 pack years. Patients with a post-bronchodilator FEV1 =30% and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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 urine pregnancy test. Patients requiring long term oxygen therapy (> 15h a day) on a daily basis for chronic hypoxemia, or who have been hospitalized or visited an emergency department for a COPD exacerbation of their airways disease in the 6 weeks prior to Visit 1 or during the run-in period. Patients with any history of asthma Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1. Patients who develop a respiratory tract infection during the screening period (up to Visit 3) must discontinue from the trial, but will be permitted to re-enroll at a later date (at least 6 weeks after the resolution of the respiratory tract infection). Patients with any history of asthma indicated by but not limited to a blood eosinophil count > 400/mm3. Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to) unstable ischemic heart disease, left ventricular failure, long term prednisone therapy, history of myocardial infarction, arrhythmia (excluding stable AF), uncontrolled hypertension, narrow-angle glaucoma, symptomatic prostatic hyperplasia, clinically significant elevated PSA levels at screening, bladder-neck obstruction or moderate to severe renal impairment, uncontrolled hypo- and hyperthyroidism, hypokalemia, hyperadrenergic state or any condition which might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study. History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. Patients with a history of long QT syndrome or whose QTc interval (Fridericia method) measured at Visit 2 is prolonged (>440 ms for males or >460 for females). Treatments for COPD and allied conditions: the following medications should not be used between Visits 1 and 18. The minimum washout prior to Visit 2 is specified below: The long acting anticholinergic agent tiotropium (bromide): 7 days. Short acting anticholinergics: 8 h. Fixed combinations of beta 2-agonists and inhaled corticosteroids: 48 h. (Patients taking fixed dose combinations of ß2 agonisists and inhaled corticosteroids must be switched to the equivalent inhaled corticosteroid as monotherapy plus salbutamol/albuterol as rescue therapy at least 48 hours before Visit 2) Long-acting beta 2-agonists: 48 h. Short acting beta 2-agonists (other than those prescribed in the study): 6 hours. Theophylline (any formulation): 7 days NOTE: During the screening period and the 7 day washout periods administration of a fixed combination of a ß2-agonist and inhaled muscarinic antagonist is acceptable if deemed appropriate by the investigator. At no other time during the study will this regimen be acceptable. A minimum of 8 hours washout prior to visit assessments is mandatory.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superior bronchodilatory efficacy of QVA149 300/50 versus placebo in patients with moderate to severe stable COPD in terms of trough FEV1 (mean of evaluations at 23h 15min and 23h 45min post dose) following 7 days of treatment delivered by the Single Dose Dry Powder Inhaler (SDDPI).;Secondary Objective: To compare the bronchodilatory efficacy of QVA149 300/50 versus QAB149 300µg in terms of trough FEV1 following 7 days of treatment. To compare the bronchodilatory efficacy of QVA149 300/50 versus QAB149 600µg in terms of trough FEV1 following 7 days of treatment. To compare the bronchodilatory efficacy of QVA149 300/50 versus QAB149 300µg and QAB149 600µg in terms of FEV1 AUC5min-12h following 7 days of treatment. To assess the safety and tolerability of QVA149 300/50 and QAB149 (300µg and 600µg) delivered by the Single Dose Dry Powder Inhaler (SDDPI) in terms of post-inhalation events, ECGs, laboratory tests, blood pressure and adverse events. To explore bronchodilatory efficacy using a range of lung function measures. ;Primary end point(s): To demonstrate the superior bronchodilatory efficacy of QVA149 300/50 versus placebo in patients with moderate to severe stable COPD in terms of trough FEV1 (mean of evaluations at 23h 15min and 23h 45min post dose) following 7 days of treatment delivered by the Single Dose Dry Powder Inhaler (SDDPI). | — |
Countries
Belgium, Germany, Netherlands
Outcome results
None listed