Clinical trial NCT02202616: Prospective Cohort Study for the Real - Life Effectiveness Evaluation of GlycOpyrronium With IndacatERol Combination in the Management of COPD in Canada (POWER Study)
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD,
QVA149,
Tiotropium,
FDC,
GlycOpyrronium With IndacatERol,
POWER
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2014-07-29
Enrollment: 401
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change From Baseline in Trough (Forced Expiratory Volume (FEV1) (Pre-dose FEV1)
timeFrame: 16 weeks study
Secondary outcomes:
measure: Change From Baseline in Trough FEV1 (Forced Expiratory Volume) to Week 4
timeFrame: Baseline, week 4
measure: Single Point and Change in Baseline Dyspnea Index and Transitional Dyspnea Index (BDI/TDI)
timeFrame: Baseline, Week 4, week 16
measure: Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Assessment Questionnaire (CAT)
timeFrame: Baseline, week 4, week 16
Other outcomes:
Locations:
city: St-Charles-Borromée
country: Canada
facility: Novartis Investigative Site
state: Quebec
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
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.