A 12-week Treatment, Multi-center, Randomized, Double-blind, Double-dummy, Parallel Group Study to Assess the Efficacy and Safety of Switching From Salmeterol/Fluticasone to QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) in Symptomatic COPD Patients
Overview
- Phase
- Phase 4
- Intervention
- QVA149 110/50 micrograms
- Conditions
- COPD
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Trough Pre-dose FEV1 in Both Arms
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This study will investigate whether switching symptomatic COPD patients from a fixed-dose combination of salmeterol/fluticasone 50/500 µg b.i.d. to a fixed dose combination of QVA149 110/50 µg o.d. leads to improved lung function and airflow. It will also assess the effect on symptom burden, breathlessness, and use of rescue medication after this switch.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Written informed consent must be obtained before any assessment is performed.
- •Male and female ≥ 40 years
- •Current or ex-smokers who have a smoking history of at least 10 pack years (Ten pack years are defined as 20 cigarettes per day for 10 years or 10 cigarettes per day for 20 years). An ex-smoker is defined as a patient who has not smoked for ≥ 6 months at visit 1
- •Confirmed diagnosis of COPD and post-bronchodilator FEV1 ≥ 30% and \< 80% of the predicted normal value and post-bronchodilator FEV1/FVC \< 0.70 at visit 1
- •Treated with salmeterol/fluticasone 50/500 µg b.i.d. for at least 3 months prior to visit 1
- •Documented CAT score of ≥ 10 at Visit 1 and 2
Exclusion Criteria
- •Treatment with any LAMA in the 2 weeks prior to visit 1
- •Presence of any contraindication, warning, precaution, hypersensitivity in the approved prescribing information for salmeterol/fluticasone
- •Prior or current diagnosis of asthma
- •More than one COPD exacerbation requiring treatment with antibiotics and/or systemic corticosteroids and/or hospitalization in the year prior to Visit 1
- •Patients who developed a COPD exacerbation of any severity within the 6 weeks before the screening (Visit 1) or between screening (Visit 1) and start of treatment (Visit 2) 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
- •Respiratory tract infection within 4 weeks prior to Visit 1
- •Respiratory tract infection between Visit 1 and
- •Patients can be re-screened 4 weeks after resolution of the infection
- •Requiring oxygen therapy prescribed for \>12 hours per day
- •Onset of respiratory symptoms, including a COPD diagnosis prior to age 40 years
Arms & Interventions
QVA149 110/50 micrograms
QVA149 110/50 micrograms o.d. Capsules for inhalation
Intervention: QVA149 110/50 micrograms
salmeterol/fluticasone 50/500 micrograms
salmeterol/fluticasone 50/500 micrograms b.i.d. Dry inhalation powder
Intervention: Salmeterol/fluticasone 50/500 microgrammes
Outcomes
Primary Outcomes
Change From Baseline in Trough Pre-dose FEV1 in Both Arms
Time Frame: Baseline, week 12
Pulmonary function assessments were performed using centralized spirometry according to international standards. Mean trough pre-dose FEV1 at Week 12 is defined as the average of the measurements taken -45min and -15min pre study medication dose in the clinic after 12 weeks of treatment (Day 84). The baseline measurement is defined as the average of the scheduled FEV1 values prior to first intake of randomized study drug at Day 1 (Visit 2).
Secondary Outcomes
- Change From Baseline in Mean Daily Use of Rescue Medication(over 12 weeks)
- Transitional Dyspnea Index (TDI) Focal Score(Baseline, week 12)
- Change From Baseline in FVC (Forced Vital Capacity)(week 12)
- Change From Baseline in Total Symptom Score- CAT (COPD Assessment Test)(week 12)