A 26-week Treatment Randomized, Double-blind, Double Dummy Study to Assess the Efficacy and Safety of QVA149
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: QVA149; Fluticasone/salmeterol; Placebo to QVA149; Placebo to fluticasone/salmeterol
Intervention description: QVA149 110/50 µg capsules q.d. for inhalation, delivered via Novartis single dose dry powder inhaler (SDDPI).; Active fluticasone/salmeterol (500/50µg) b.i.d via a dry power inhaler Accuhaler® device.; Placebo to QVA149 with SDDPI; Placebo to fluticasone/salmeterol with Accuhaler
Intervention MeSH terms: Fluticasone; Xhance; Glycopyrrolate; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 744.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: chronic obstructive pulmonary disease

Summary:

      To demonstrate the non-inferiority of QVA149 110/50 µg o.d. to fluticasone/salmeterol 500/50
      µg b.i.d. in terms of trough Forced Expiratory Volume in one second (FEV1) (mean of 23 hours
      15 min and 23 hours 45 min post QVA149 dose) following 26 weeks of treatment in patients with
      moderate to severe COPD
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with moderate to severe stable COPD (Stage II or Stage III) according to
             Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guideline.

        Current or ex-smokers who have a smoking history of at least 10 pack years. Patients with a
        post-bronchodilator Forced Expiratory Volume in one second (FEV1) ≥ 30% and < 80% of the
        predicted normal, and post-bronchodilator FEV1/FVC < 0.7.

        Modified Medical Research Council (mMRC) grade of at least 2 at Visit 2.

        Exclusion Criteria:

          -  Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
             female after conception and until the termination of gestation, confirmed by a
             positive Human Chorionic Gonadotropin (hCG) laboratory test.

        Patents with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia (BPH),
        bladder-neck obstruction, moderate to severe renal impairment or urinary retention. BPH
        patients who are stable on treatment can be considered.

        Patients with a history of long QT syndrome or whose QTc measured at run-in (Visit 2)
        (Fridericia method) is prolonged (>450 ms for males and females) as confirmed by the
        central Electrocardiogram (ECG) assessor.

        Patients with Type I or uncontrolled Type II diabetes. Patients who have not achieved
        spirometry result at Visit 2 in accordance with American Thoracic Society/European
        Respiratory Society (ATS/ERS) criteria for acceptability and repeatability.

        Patients with, a) any history of asthma or, b) onset of respiratory symptoms prior to age
        40 years.

        Patients with concomitant pulmonary disease (e.g. lung fibrosis, primary bronchiectasis,
        sarcoidosis, interstitial lung disorder, pulmonary hypertension).

        Other protocol-defined inclusion/exclusion criteria may apply