Prospective Cohort Study for the Real - Life Effectiveness Evaluation of GlycOpyrronium With IndacatERol Combination in the Management of COPD in Canada (POWER Study)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Glycopyrronium /Indacaterol maleate
Intervention description: Glycopyrronium 50mcg/Indacaterol maleate 110mcg once daily by a breezhaler device
Intervention MeSH terms: Glycopyrrolate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 401.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD,; QVA149,; Tiotropium,; FDC,; GlycOpyrronium With IndacatERol,; POWER

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.