Prospective Cohort Study for the Real - Life Effectiveness Evaluation of GlycOpyrronium With IndacatERol Combination in the Management of COPD in Canada (POWER Study) (POWER)

• ClinicalTrials.gov Identifier: NCT02202616
• Recruitment Status: Completed
• First Posted: July 29, 2014
• Results First Posted: June 24, 2019
• Last Update Posted: July 2, 2019
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease	Intervention/treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: Glycopyrronium /Indacaterol maleate	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 401 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
ULTIBRO BREEZHALER; 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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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
2. 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.
3. 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.

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Canada, Quebec

Novartis Investigative Site

St-Charles-Borromée, Quebec, Canada, J6E 2B4

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):

Study Protocol  [PDF] June 3, 2015

Statistical Analysis Plan  [PDF] September 14, 2017

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kaplan A, Chapman KR, Anees SM, Mayers I, Rochdi D, Djandji M, Préfontaine 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.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02202616
• Other Study ID Numbers: CQVA149ACA01
• First Posted: July 29, 2014
• Results First Posted: June 24, 2019
• Last Update Posted: July 2, 2019
• Last Verified: June 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

COPD,; QVA149,; Tiotropium,; FDC,; GlycOpyrronium With IndacatERol,; POWER

Additional relevant MeSH terms:

Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Lung Diseases; Respiratory Tract Diseases; Maleic acid; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action