Evaluation of the Efficacy and Safety of QVA149 (110/50 μg o.d.) vs Tiotropium (18 µg o.d.) + Salmeterol/Fluticasone Propionate FDC (50/500 µg b.i.d.) in Patients With Moderate to Severe COPD
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: QVA149; Tiotropium; Salmeterol/fluticasone
Intervention description: QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept 1 SDDPI; Tiotropium will be supplied as commercially available blisters, delivered via HandiHaler®; Salmeterol/fluticasone propionate dry inhalation powder delivered via Accuhaler™
Intervention MeSH terms: Fluticasone; Tiotropium Bromide; Salmeterol Xinafoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1053.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD, QVA149

Summary:

      This study will evaluate the efficacy and safety of QVA149 (110/50 μg o.d.) vs tiotropium (18
      µg o.d.) + salmeterol/fluticasone propionate FDC (50/500 µg b.i.d.) in patients with moderate
      to severe COPD
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have signed Informed Consent Form prior to initiation of any
             study-related procedure.

          -  Male and female adults aged ≥ 40 years.

          -  Patients with moderate to severe airflow obstruction with stable COPD (Stage 2 or
             Stage 3) according to the 2014 GOLD Guidelines.

          -  Patients with a post-bronchodilator FEV1 ≥40 and < 80% of the predicted normal value,
             and post-bronchodilator FEV1/FVC < 0.70 at run-in Visit 101. (Post refers to 15 min
             after inhalation of 400 µg of salbutamol).

          -  Current or ex-smokers who have a smoking history of at least 10 pack years (e.g. 10
             pack years = 1 pack /day x 10 years, or ½ pack/day x 20 years). An ex-smoker is
             defined as a patient who has not smoked for ≥ 6 months at screening.

          -  Patients who are on triple treatment at least for the last 6 months (LAMA +LABA/ICS).

        Exclusion Criteria:

          -  Patients who have not achieved acceptable spirometry results at Visit 101 in
             accordance with ATS (American Thoracic Society)/ERS (European Respiratory Society)
             criteria for acceptability (one retest may be performed for patients that don't meet
             the acceptability criteria) .

          -  Patients who have had more than one COPD exacerbation that required treatment with
             antibiotics and/or oral corticosteroids and/or hospitalization in the last year prior
             to Visit 1.

          -  Patients who developed a COPD exacerbation of any severity either 6 weeks before the
             screening (Visit 1) or between screening (Visit 1) and treatment (Visit 201) will not
             be eligible but will be permitted to be re-screened after a minimum of 6 weeks after
             the resolution of the COPD exacerbation.

        Other protocol-defined inclusion/exclusion criteria may apply