Randomized, Double-blind, Placebo-controlled, Multicenter, Cross-over Study to Assess the Effects of a 3 Week Therapy Each With QVA149 Versus Placebo on Pulmonary Function and Average Physical Activity Levels in Patients With COPD.
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: QVA149; Placebo
Intervention description: QVA149 (110/50 µg) once a day via Breezhaler® device; Placebo once a day via Breezhaler® device
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 194.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic obstructive pulmonary disease; COPD

Summary:

      This study is designed to assess the effect of QVA149 (110/50 ug q.d.) versus placebo on
      pulmonary function and average physical activity levels in patients with moderate to severe
      Chronic Obstructive Pulmonary Disease (COPD).
    

Eligibility criteria:

        Inclusion Criteria:

        Patients with stable COPD according to the current GOLD guidelines (GOLD 2013). 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 yrs, or ½ pack/day x 20 yrs)..

        Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥40% and <80% of
        the predicted normal, and a post-bronchodilator FEV1/FVC <0.70

        Exclusion Criteria:

        Patients with conditions contraindicated for treatment with, or having a history of
        reactions/hypersensitivity to any of the following inhaled drugs, drugs of a similar class
        or any component thereof, anticholinergics, long and short acting beta2 agonists,
        sympathomimetic amines, lactose or any of the other excipients Patients who have a
        clinically significant ECG abnormality at Visit 1, who in the judgment of the investigator
        would be at potential risk if enrolled into the study.

        Patients with paroxysmal (e.g. intermittent) atrial fibrillation are excluded. Patients
        with persistent atrial fibrillation as defined by continuous atrial fibrillation for at
        least 6 months and controlled with a rate control strategy (i.e., beta blocker, calcium
        channel blocker, pacemaker placement, digoxin or ablation therapy) for at least 6 months
        may be considered for inclusion. In such patients, atrial fibrillation must be present at
        baseline and screening visits, with a resting ventricular rate < 100/min.

        Patients with Type I or uncontrolled Type II diabetes and patients with a history of blood
        glucose levels consistently outside the normal range Patients with narrow-angle glaucoma,
        symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal
        impairment or urinary retention.

        Patients with a history of malignancy of any organ system, treated or untreated, within the
        past 5 years whether or not there is evidence of local recurrence or metastases, with the
        exception of localized basal cell carcinoma of the skin. Patients with non-melanoma skin
        carcinoma may be considered for the study.

        Patients with a body mass index (BMI) of more than 40 kg/m2. Women who are pregnant or
        breast feeding Patients requiring long term oxygen therapy on a daily basis for chronic
        hypoxemia.

        Patients who have had a COPD exacerbation that required treatment with antibiotics and/or
        oral corticosteroids and/or hospitalization in the 6 weeks prior to screening.

        Patients who have had a respiratory tract infection within 4 weeks prior to screening.

        Patients with any history of asthma. Patients with concomitant pulmonary disease Patients
        with clinically significant bronchiectasis. Other protocol-defined inclusion/exclusion
        criteria may apply