NCT01636076CompletedPhase 2
A Randomized, Double-blind, 12-week Treatment, Parallel-group Study to Evaluate the Efficacy and Safety of QMF149 (150 µg/160 µg o.d.) Compared With Salmeterol Xinafoate/Fluticasone Propionate (50 µg/500 µg b.i.d.) in Patients With Chronic Obstructive Pulmonary Disease
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 629
- Locations
- 1
- Primary Endpoint
- Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for Trough FEV1 (L) on Day 85
Study Overview
Brief Summary
To compare the efficacy, safety and pharmacokinetics of QMF149 delivered via Concept1 to salmeterol xinafoate/fluticasone propionate delivered via Accuhaler in adult patients with COPD
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with moderate to very severe COPD (GOLD 2 to GOLD 4) according to the 2011 Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines
- •Patients with a post-bronchodilator FEV1 < 70% of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70 at run-in (Visit 101).
- •Current or ex-smokers who have a smoking history of at least 10 pack years (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked. e.g.10 pack years = 1 pack /day x 10 yrs, or ½ pack/day x 20 yrs). An ex-smoker may be defined as a subject who has not smoked for ≥ 6 months at screening.
Exclusion Criteria
- •Patients who have had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the 6 weeks prior to screening (Visit 1).
- •Patients who develop a COPD exacerbation between screening (Visit 1) and treatment (Visit 201) will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation.
- •Patients who have had a respiratory tract infection within 4 weeks prior to screening Visit
- •Patients who develop a respiratory tract infection between screening (Visit 1) and treatment (Visit 201) will not be eligible, but will be permitted to be re-screened 4 weeks after the resolution of the respiratory tract infection.
- •Patients requiring long term oxygen therapy prescribed for >12 hours per day.
- •Patients with, a) any history of asthma or, b) onset of respiratory symptoms prior to age 40 years.
- •Other protocol-defined inclusion/exclusion criteria may apply.
Arms & Interventions
Salmeterol xinafoate/fluticasone propionate
Active Comparator
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
Intervention: Salmeterol (Drug)
QMF149
Experimental
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
Intervention: QMF149 (Drug)
Outcomes
Primary Outcomes
Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for Trough FEV1 (L) on Day 85
Time Frame: 12 weeks
Spirometry is conducted according to the global standard. Trough FEV1 is defined as the average of the 23 hour 10 minute and 23 hour 45 minute post dose FEV1 readings.
Secondary Outcomes
- Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for FEV1 (L), by Visit and Timepoint(Day 1 through day 85)
- FEV1/FVC at Each Timepoint(Day 1, Day 2, Day 28, Day , Day 29, Day 84, Day 85)
- Summary Statistics of COPD Exacerbations over12 Weeks as Defined by Chronic Pulmonary Disease Tool (EXACT)(12 weeks)
- Plasma Cortisol Concentrations at Each Timepoint(Day 1, Day 28, Day 84)
- Pharmacokinetic Parameter: Cmax(Day 28, 84)
- Pharmacokinetic Parameter--AUC0-t(Day 28, 84)
- Forced Vital Capacity (FVC) at Each Timepoint(Day 1, Day 2, Day 28, Day , Day 29, Day 84, Day 85)
- Analysis of the Proportion of Subjects With a Clinically Important Improvement of >=1 Point in the TDI (Transitional Dyspnoea Index)Focal Score by Visit(4 and 12 weeks)
- Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale(Baseline, 4 and 12 weeks)
- Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Sleep Quantity Subscale(Baseline, 4 and 12 weeks)
- Annual Rate of COPD Exacerbations(12 weeks)
- Trough FEV1 After First Dose and After 4 Weeks of Treatment(Day 1 and Day 85)
- FEV1 (L) on Day 1 Between-treatment Comparisons of AUC (5min - 4h)(Day 1)
- Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for AUC (5 Min - 23 h 45 Min) for FEV1 (L) on Day 28 and Day 84 (Full Analysis Set, 24-h Profiling Subgroup)(Day 28, Day 84)
- Patient Reported Outcome Measures: SGRQ (St. George's Respiratory Questionnaire)(4 and 12 weeks)
- Duration (in Days) of COPD Exacerbations(12 weeks)
- Plasma Drug Concentrations (Pharmacokinetics) at Each Timepoint(Day 1, 29, 84)
- Pharmacokinetic Parameter--Tmax(Day 28, 84)
- FEV1 AUC (5 Min-4 h),(Day 1(Baseline), Day 28, Day 84)
- The Usage of Rescue Medication (Short Acting β2-agonist)(12 weeks)
- The Overall Change in Usage of Rescue Medication (Short Acting β2-agonist) .(Baseline to 12 weeks)
- Patient Reported Outcome Measures: COPD Assessment Test(Baseline, 4 and 12 weeks)
- Percentage of Patients With at Least One Exacerbation up to Week 12(12 weeks)
- Time (in Days) to Permanent Study Discontinuation Due to COPD Exacerbation(12 weeks)
- Time to First COPD Exacerbation(12 weeks)
- The Percentage of Patients Who Permanently Discontinued Due to COPD Exacerbation(12 weeks)
- Total Amount (in Doses) of Systemic Corticosteroid Used to Treat COPD Exacerbation During the 12 Week Treatment Period(12 weeks)
Investigators
Study Sites (1)
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