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

NCT02202616 | Completed Phase 4 Results DMC

• 1 other identifier: CQVA149ACA01
• Study Type: interventional
• Target: 401
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  16 weeks study

Secondary Outcomes (3)

• Change From Baseline in Trough FEV1 (Forced Expiratory Volume) to Week 4

  Baseline, week 4

• Single Point and Change in Baseline Dyspnea Index and Transitional Dyspnea Index (BDI/TDI)

  Baseline, Week 4, week 16

• Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Assessment Questionnaire (CAT)

  Baseline, week 4, week 16

Study Arms (1)

ULTIBRO BREEZHALER

OTHER

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

Interventions

Glycopyrronium /Indacaterol maleate DRUG

Glycopyrronium 50mcg/Indacaterol maleate 110mcg once daily by a breezhaler device

ULTIBRO BREEZHALER

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

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

Location

Related Publications (1)

• 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.

  PMID: 30718952 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Glycopyrrolate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2014
• First Posted: July 29, 2014
• Study Start: August 27, 2014
• Primary Completion: April 5, 2017
• Study Completion: April 5, 2017
• Last Updated: July 2, 2019
• Results First Posted: June 24, 2019

Record last verified: 2019-06

Locations

CA (1)