A 12 Week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation.
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: QVA149; QAB149; NVA237; Placebo
Intervention description: QVA149 was supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI; QAB149 was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI.; NVA237 was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI.; Placebo was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI.
Intervention MeSH terms: Glycopyrrolate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1042.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD, QVA149

Summary:

      This study will assess the efficacy, safety and tolerability of QVA149 in patients with
      moderate to severe airflow limitation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients that have signed informed consent and are >/= 40 years of
             age.

          -  Patients with stable COPD according to GOLD 2011.

          -  Patients with a post-bronchodilator FEV1 of >/= 30% and < 80% predicted and a
             post-bronchodilator FEV1/FVC <0.70.

          -  Current or ex-smokers who have a smoking history of at least 10 pack years.

          -  Patients with an mMRC grade 2 or greater.

        Exclusion Criteria:

          -  Patients with Type I or uncontrolled Type II diabetes - Patients with a history of
             long QT syndrome or whose QTc measured at Visit 101 (Fridericia method) is prolonged
             (>450 ms for males and females) and confirmed by a central assessor. (These patients
             should not be re-screened.)

          -  Patients who have a clinically significant ECG abnormality at Visit 101 or Visit 102.
             (These patients should not be re-screened.)

          -  Patients with a history of malignancy of any organ system, treated or untreated,
             within the last five years.

          -  Patients with narrow-angle glaucoma, BPH or bladder-neck obstruction or
             moderate-severe renal impairment or urinary retention.

          -  Patients who had a COPD exacerbation within 6 weeks prior to screening.

          -  Patients who have a respiratory tract infection within 4 weeks prior to screening.

          -  Patients requiring long term oxygen therapy prescribed for more than 12 hr per day.

          -  Patients with a history of asthma. 8. Patients with an onset of respiratory symptoms,
             including COPD diagnosis, prior to age 40 years.

          -  Patients with a blood eosinophil count of greater than 600 mm/3 during run-in.

          -  Patients with concomitant pulmonary disease.

          -  Patients with a diagnosis of alpha-1 anti-trypsin deficiency.

          -  Patients with active pulmonary tuberculosis.

          -  Patients in the active phase of a pulmonary rehabilitation programme.

          -  Other protocol-defined inclusion/exclusion criteria may apply