QVA149 Versus Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Drug: fluticasone/salmeterolDrug: Placebo to fluticasone/salmeterol
- Registration Number
- NCT01315249
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
The purpose of this study is to compare the efficacy and safety/tolerability of indacaterol and glycopyrronium (QVA149) (fixed-dose combination) with fluticasone/salmeterol over a 26-week period in patients with moderate to severe COPD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 523
- Smoking history of at least 10 pack years
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2009)
- Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) >40% and < 80% of the predicted normal value and post-bronchodilator FEV1/Forced Vital Capacity (FVC) <70%
- Patients who have had a COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the last year.
- Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia.
- Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1.
- Patients with concomitant pulmonary disease
- Patients with a history of asthma
- Any patient with lung cancer or a history of lung cancer (within last 5 years)
- Patients with a history of certain cardiovascular co-morbid conditions
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description QVA149 indacaterol and glycopyrronium (QVA149) Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol. QVA149 Placebo to fluticasone/salmeterol Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol. fluticasone/salmeterol fluticasone/salmeterol Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149). fluticasone/salmeterol Placebo to indacaterol and glycopyrronium (QVA149) Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
- Primary Outcome Measures
Name Time Method Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 Week 26 Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. FEV1 was normalized by 12 hours (divided by time). This outcome measures absolute values at week 26. Results are obtained from linear mixed model.
- Secondary Outcome Measures
Name Time Method Standardized Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 Hours Week 12 Standardized Forced Expiratory Volume in 1 Second (FEV1) was measured with spirometry conducted according to internationally accepted standards. Measurements were made between 0 and 12 hours after treatment. FEV1 was normalized by 12 hours (divided by time). This outcome measures absolute values at week 12. Results are obtained from linear mixed model.
Forced Vital Capacity at All-time Points (Week 12) -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 12 Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.
This outcome measures absolute values at -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose week 12. Results are obtained from linear mixed model.Forced Vital Capacity at All-time Points (Week 26) -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26 Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.
This outcome measures absolute values at -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26. Results are obtained from linear mixed model.Focal Score of the Transitional Dyspnea Index (TDI) 12 weeks and 26 weeks Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement.
Total Score of the St. George's Respiratory Questionnaire (SGRQ-C) 12 weeks and 26 weeks The total score of the St. George's Respiratory Questionnaire (SGRQ-C) is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life.
Mean Change From Baseline in Daily Number of Puffs of Rescue Medication Baseline, 12 weeks and 26 weeks Participants maintained a diary to record the daily number of puffs of rescue medication used to treat COPD symptoms.
Change From Baseline in Symptom Scores Reported Using the Ediary 12 weeks and 26 weeks Participants maintained an ediary to record daily symptom scores (AM and PM) over 12 weeks and 26 weeks of treatment. This analysis compares the mean symptom scores over 12 weeks and 26 weeks compared to baseline. The diary records morning and evening daily clinical symptoms including cough, wheezing, shortness of breath, sputum volume, sputum purulence, night time awakenings and rescue medication use.
Scale ranges: ranges are 0 to 3 with varying scale descriptions that pertain to the question being asked.
0 is the minimum score = "none" or "No symptoms" or "never" or "No"
1. = mild, a little
2. = moderate
3. = severe For the scale range provided, high values represent a worse outcome.Inspiratory Capacity (IC) at All-time Points (12 Weeks) 12 weeks After 12 weeks of treatment, Inspiratory Capacity (IC) was measured via spirometry, conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.
Inspiratory Capacity (IC) at All-time Points (26 Weeks) 26 weeks After 26 weeks of treatment, Inspiratory Capacity (IC) was measured via spirometry, conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.
Number of Participants With Adverse Events 26 weeks The assessment of safety was based on Adverse Events. A summary of adverse events is presented with this outcome, additional details are provided in Adverse Events Section.
Trial Locations
- Locations (1)
Novartis Investigative Site
🇪🇸Valladolid, Spain