Prospective Cohort Study for the Real - Life Effectiveness Evaluation of GlycOpyrronium With IndacatERol Combination in the Management of COPD in Canada (POWER Study) (POWER)
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|ClinicalTrials.gov Identifier: NCT02202616|
Recruitment Status : Completed
First Posted : July 29, 2014
Results First Posted : June 24, 2019
Last Update Posted : July 2, 2019
This is a single cohort, prospective post approval study conducted on patients with COPD in Canada. The study will enroll patients that have not responded to their current treatment of tiotropium alone, or who are on the fixed dose combinations fluticasone propionate/salmeterol. Only patients for whom the physician has decided to change treatment due to lack of efficacy will be eligible to be enrolled in the study.
Also will evaluate the real-life effectiveness of QVA149 (indacaterol 110 mcg/glycopyrronium 50 mcg) in the management of patients.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Drug: Glycopyrronium /Indacaterol maleate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||401 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Cohort Study for the Real - Life Effectiveness Evaluation of GlycOpyrronium With IndacatERol Combination in the Management of COPD in Canada (POWER Study)|
|Actual Study Start Date :||August 27, 2014|
|Actual Primary Completion Date :||April 5, 2017|
|Actual Study Completion Date :||April 5, 2017|
Patients diagnosed with chronic obstructive pulmonary disorder (COPD) who are symptomatic (CAT score over 10) and who are treated with Tiotropium (SPIRIVA HANDALER) or Fluticasone propionate/Salmeterol- ADVAIR DISKUS (FDC).
Drug: Glycopyrronium /Indacaterol maleate
Glycopyrronium 50mcg/Indacaterol maleate 110mcg once daily by a breezhaler device
- Change From Baseline in Trough (Forced Expiratory Volume (FEV1) (Pre-dose FEV1) [ Time Frame: 16 weeks study ]Primary end points: To evaluate the real-life effectiveness of QVA149 (indacaterol 110 mcg/glycopyrronium 50 mcg) in the management of patients with COPD who have symptoms defined as CAT score >10 with tiotropium monotherapy; effectiveness will be assessed as the mean change in trough FEV1 from baseline to 16 weeks. and to evaluate the real-life effectiveness of QVA149 (indacaterol 110 mcg/glycopyrronium 50 mcg) in the management of patients with COPD who have symptoms defined as CAT score >10 while on treatment with FDC of fluticasone propionate/salmeterol; effectiveness will be assessed as the mean change in trough FEV1 from baseline to 16 weeks.
- Change From Baseline in Trough FEV1 (Forced Expiratory Volume) to Week 4 [ Time Frame: Baseline, week 4 ]Portable spirometers will be provided to investigators and they will use this device for all of their patient measurements of FEV1 during the trial
- Single Point and Change in Baseline Dyspnea Index and Transitional Dyspnea Index (BDI/TDI) [ Time Frame: Baseline, Week 4, week 16 ]A trained assessor interviewed the patient and graded the degree of impairment due to dyspnea (difficulty breathing). BDI/TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort and captures changes from baseline. BDI was measured at day 1 prior to the first dose with domain scores ranging from 0=very severe to 4=no impairment and a total score ranging from 0 to 12(best). TDI captures changes from baseline. Each domain is scored from -3=major deterioration to 3=major improvement to give an overall TDI focal score of -9 to 9. Higher numbers indicate a better score. The BDI was assessed at Baseline, whereas the TDI was assessed at Week 4 and Week 16.
- Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Assessment Questionnaire (CAT) [ Time Frame: Baseline, week 4, week 16 ]The CAT is an 8 item questionnaire that assesses the impact of COPD on the patient's functional status. Scores for each of the 8 items are summed to give an overall score (out of 40). The score ranges from 0-40 where higher scores represent worse health status. CAT scores ≥ 10 are associated with significantly impaired health status.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202616
|Novartis Investigative Site|
|St-Charles-Borromée, Quebec, Canada, J6E 2B4|
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|