Efficacy, Safety and Tolerability of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (GLOW7)
|ClinicalTrials.gov Identifier: NCT01566604|
Recruitment Status : Completed
First Posted : March 29, 2012
Results First Posted : August 8, 2014
Last Update Posted : August 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease (COPD)||Drug: NVA237 Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||460 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A 26-week Treatment, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of NVA237 (50 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease|
|Study Start Date :||March 2012|
|Primary Completion Date :||June 2013|
|Study Completion Date :||June 2013|
NVA237 50 µg once daily delivered via a single dose dry powder inhaler
Delivered via a single dose dry powder inhaler
Placebo Comparator: Placebo
Placebo once daily delivered via a single dose dry powder inhaler
Delivered via a single dose dry powder inhaler
- Trough Forced Expiratory Volume in One Second (FEV1) [ Time Frame: 12 weeks ]Baseline FEV1 was defined as the average of the -45 min and -15 min FEV1 values taken on day 1 prior to the first dose of study medication. Trough FEV1 was defined as the mean of the post-dose 23 h 15 min and the 23 h 45 min FEV1 values. FEV1 was measured using central spirometry according to ATS/ERS standardization. Trough FEV1 was analyzed using a MIXED model for the full analysis set population. The model contained treatment as a fixed effect with the baseline FEV1 measurement, FEV1 prior to inhalation of short acting bronchodilator, FEV1 45 min post inhalation of short acting bronchodilator and baseline inhaled corticosteroids (ICS) use as covariates.
- Transition Dyspnea Index (TDI) Score [ Time Frame: Baseline, week 12, week 26 ]Dyspnea was measured at baseline using the Baseline Dyspnea Index (BDI) and during the treatment period using the TDI, which captures changes from baseline. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort, and each domain scored from -3 (major deterioration) to +3 (major improvement), giving an overall score of -9 to +9. A negative score indicates deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.
- Change From Baseline in Daily Rescue Medication Use (Number of Puffs) [ Time Frame: Baseline, 26 weeks ]The participant recorded the rescue medication taken in an electronic diary between visits and in the spirometry device during study visits. Daytime and nighttime rescue medication use (number of puffs) over 26 weeks was analyzed.
- 24h Trough FEV1 [ Time Frame: Day 1, Week 26 ]Trough FEV1 was defined as the mean of the post-dose 23 h 15 min and the 23 h 45 min FEV1 values. This was measured using central spirometry according to ATS/ERS standardization. This was analyzed using the same MIXED model as specified for the primary analysis.
- FEV1 and Forced Vital Capacity (FVC) [ Time Frame: Day 1 at 5, 15, 30 minutes (min) and 1 hour (h) post dose; days 2, 86, 184 at 23 (h) 15 min and 23 h 45 min post dose; days 29, 85, 183 at -45 and -15 min pre-dose and 5, 15, and 30 min post dose ]FEV1 and FVC were measured using central spirometry according to ATS/ERS standardization. Both were analyzed using the same MIXED model as specified for the primary analysis.
- Peak FEV1 [ Time Frame: Day 1, week 12, week 26 ]Peak FEV1 was defined as the maximum FEV1 0-4 h post-dose. Peak Fev1 was measured at 45min and 15min pre-dose and up to 4h post dose at day 1, week 12 and week 26, using central spirometry according to ATS/ERS standardization. It was analyzed using the same MIXED model as specified for the primary analysis.
- Standardized FEV1 Area Under the Curve (AUC(5 Min-4 h)) Post-dose [ Time Frame: Day 1, week 12, week 26 ]The standardized (with respect to time) AUC for FEV1 was calculated between 5 min and 4h post morning dose at day 1, week 12 and week 26. The AUC (5 min-4 h) for FEV1 at each visit was analyzed using the same MIXED model as specified for the primary analysis.
- Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptoms (Cough, Wheezing, Shortness of Breath, Sputum Volume, Sputum Color and Night Time Awakenings) [ Time Frame: Baseline, 26 weeks ]In an electronic diary, the participant responded to 6 questions twice daily to report on the degree of symptoms over the past 12 hours of the morning and evening. The questions covered the participant's degree of overall symptoms, and degrees of individual symptoms of coughing, wheezing, amount of sputum, color of sputum and breathlessness. Each question scored from 0 to 3 where 0 represented no symptom present and 3 represented the worst degree of that symptom. A negative change in symptom score indicates improvement.
- Time to First Moderate or Severe COPD Exacerbation [ Time Frame: 26 weeks ]A COPD exacerbation was defined as a worsening of the following two or more major symptoms for at least 2 consecutive days:1) dyspnea; 2) sputum volume; 3) sputum purulence; or defined as a worsening of any 1 major symptom together with an increase in any 1 of the following minor symptoms for at least 2 consecutive days: 1) sore throat; 2) colds (nasal discharge and/or nasal congestion); 3) fever without other cause; 4) cough; 5) wheeze. COPD exacerbations were recorded in the patient diary and other source documents.
- Number of Moderate and Severe COPD Exacerbations [ Time Frame: 26 weeks ]COPD exacerbations were recorded in the patient diary and other source documents. The rate of COPD exacerbations during the 26 week treatment period was analyzed using a generalized linear model assuming a negative binomial distribution.
- The Total Score of the St George's Respiratory Questionnaire (SGRQ) [ Time Frame: Week 12, week 26 ]SGRQ is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity and impacts. The lowest possible score is zero and the highest possible score is 100. Higher scores correspond to greater impairment in quality of life. The health-related quality of life was measured using SGRQ. It was completed by the participant at the investigators site.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01566604
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|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|