Back to resultsProspective Cohort Study for the Real - Life Effectiveness Evaluation of GlycOpyrronium With IndacatERol Combination in the Management of COPD in Canada (POWER Study) (POWER)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Glycopyrronium /Indacaterol maleate
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD,, QVA149,, Tiotropium,, FDC,, GlycOpyrronium With IndacatERol,, POWER
Eligibility Criteria
Inclusion Criteria:
- Patient diagnosed and treated for moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease according to physician's assessment
- Smoking history of > 10 pack - years.
- On-going treatment with tiotropium or fixed dose combination of LABA/ICS, specifically combinations fluticasone propionate/salmeterol for a minimum of three months but demonstrating persistence of symptoms indicating change of treatment to combination therapy **using a CAT score > 10.
- Treatment with QVA149 is indicated as per the product monograph and appropriate for the patient as per the judgment of the treating physician.
- Patient has signed informed consent agreeing to participate in the study and undergo the study treatments and allowing the use of their data for the purposes of the study.
Patient is expected to be available for 16 weeks after study enrolment
- Assessed as per routine care or as documented in the patient's chart. ** As determined and decided by the treating physician prior to enrolment of the patient in the study.
Exclusion Criteria:
Patients fulfilling any of the following criteria are not eligible for inclusion in this study. No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients.
- Patients not willing to sign an informed consent.
- Patient on maintenance treatment including triple therapy (LABA +LAMA+ICS) for COPD
- Patients with a diagnosis of asthma or history of asthma.
- Patients who have had two or more moderate to severe exacerbations during the last 12 months prior to study enrolment. A moderate COPD exacerbation is defined by requirement for treatment with systemic corticosteroids or antibiotics or both. A severe COPD exacerbation is defined by hospitalization, including an emergency room visit of longer than 24 h.
- Patients who had an exacerbation within the previous 6 weeks to enrolment.
- Patients who as per physician clinical judgment will require ICS treatment co-administered with QVA149 during the study period.
- Patients with other chronic respiratory conditions that may affect the outcome of treatment including but not limited to lung cancer.
Sites / Locations
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
ULTIBRO BREEZHALER
Arm Description
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).
Outcomes
Primary Outcome Measures
Change From Baseline in Trough (Forced Expiratory Volume (FEV1) (Pre-dose FEV1)
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.
Secondary Outcome Measures
Change From Baseline in Trough FEV1 (Forced Expiratory Volume) to 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)
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)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02202616
Brief Title
Prospective Cohort Study for the Real - Life Effectiveness Evaluation of GlycOpyrronium With IndacatERol Combination in the Management of COPD in Canada (POWER Study)
Acronym
POWER
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
August 27, 2014 (Actual)
Primary Completion Date
April 5, 2017 (Actual)
Study Completion Date
April 5, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD,, QVA149,, Tiotropium,, FDC,, GlycOpyrronium With IndacatERol,, POWER
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
401 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ULTIBRO BREEZHALER
Arm Type
Other
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Glycopyrronium /Indacaterol maleate
Intervention Description
Glycopyrronium 50mcg/Indacaterol maleate 110mcg once daily by a breezhaler device
Primary Outcome Measure Information:
Title
Change From Baseline in Trough (Forced Expiratory Volume (FEV1) (Pre-dose FEV1)
Description
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.
Time Frame
16 weeks study
Secondary Outcome Measure Information:
Title
Change From Baseline in Trough FEV1 (Forced Expiratory Volume) to Week 4
Description
Portable spirometers will be provided to investigators and they will use this device for all of their patient measurements of FEV1 during the trial
Time Frame
Baseline, week 4
Title
Single Point and Change in Baseline Dyspnea Index and Transitional Dyspnea Index (BDI/TDI)
Description
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.
Time Frame
Baseline, Week 4, week 16
Title
Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Assessment Questionnaire (CAT)
Description
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.
Time Frame
Baseline, week 4, week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient diagnosed and treated for moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease according to physician's assessment
Smoking history of > 10 pack - years.
On-going treatment with tiotropium or fixed dose combination of LABA/ICS, specifically combinations fluticasone propionate/salmeterol for a minimum of three months but demonstrating persistence of symptoms indicating change of treatment to combination therapy **using a CAT score > 10.
Treatment with QVA149 is indicated as per the product monograph and appropriate for the patient as per the judgment of the treating physician.
Patient has signed informed consent agreeing to participate in the study and undergo the study treatments and allowing the use of their data for the purposes of the study.
Patient is expected to be available for 16 weeks after study enrolment
Assessed as per routine care or as documented in the patient's chart. ** As determined and decided by the treating physician prior to enrolment of the patient in the study.
Exclusion Criteria:
Patients fulfilling any of the following criteria are not eligible for inclusion in this study. No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients.
Patients not willing to sign an informed consent.
Patient on maintenance treatment including triple therapy (LABA +LAMA+ICS) for COPD
Patients with a diagnosis of asthma or history of asthma.
Patients who have had two or more moderate to severe exacerbations during the last 12 months prior to study enrolment. A moderate COPD exacerbation is defined by requirement for treatment with systemic corticosteroids or antibiotics or both. A severe COPD exacerbation is defined by hospitalization, including an emergency room visit of longer than 24 h.
Patients who had an exacerbation within the previous 6 weeks to enrolment.
Patients who as per physician clinical judgment will require ICS treatment co-administered with QVA149 during the study period.
Patients with other chronic respiratory conditions that may affect the outcome of treatment including but not limited to lung cancer.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
St-Charles-Borromée
State/Province
Quebec
ZIP/Postal Code
J6E 2B4
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
30718952
Citation
Kaplan A, Chapman KR, Anees SM, Mayers I, Rochdi D, Djandji M, Prefontaine D, McIvor A. Real-life effectiveness of indacaterol-glycopyrronium after switching from tiotropium or salmeterol/fluticasone therapy in patients with symptomatic COPD: the POWER study. Int J Chron Obstruct Pulmon Dis. 2019 Jan 18;14:249-260. doi: 10.2147/COPD.S185485. eCollection 2019.
Results Reference
derived
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Prospective Cohort Study for the Real - Life Effectiveness Evaluation of GlycOpyrronium With IndacatERol Combination in the Management of COPD in Canada (POWER Study)
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