Efficacy and Safety of Four Doses of Glycopyrronium Bromide (NVA237) in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD), in Comparison to an Active Comparator Tiotropium
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: NVA237; Placebo; Tiotropium
Intervention description: single-dose dry-powder inhaler (SDDPI); single-dose dry-powder inhaler (SDDPI); Handihaler inhaler
Intervention MeSH terms: Glycopyrrolate; Tiotropium Bromide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 83.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD, Age≥40 yrs, Glycopyrronium Bromide

Summary:

      This study will assess the efficacy and safety of glycopyrronium bromide (NVA237) in patients
      with stable COPD, in comparison to an active comparator.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior
             to initiation of any study-related procedure.

          -  Patients with moderate to severe COPD according to the Gold Guidelines (2006).

          -  Patients who have smoking history of at least 10 pack years. Ten pack-years is defined
             as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.

          -  Patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥30%
             and < 80% of the predicted normal, and post-bronchodilator FEV1/forced vital capacity
             (FVC) < 0.7 at Visit 2. For non-Japanese patients predicted FEV1 should be calculated
             according to Quanjer predictive equations [Quanjer PH 1993], for Japanese patients
             predicted FEV1 should be calculated according to Japanese Respiratory Society
             predictive tables [Japan Respiratory Society 2001].

        Exclusion Criteria:

          -  Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy
             test).

          -  Patients requiring oxygen therapy on a daily basis for chronic hypoxemia, or who have
             been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to
             Visit 1 or between Visit 1 and Visit 3.

          -  Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1.
             Patients who develop a respiratory tract infection during the screening period (up to
             Visit 3) must discontinue from the trial, but will be permitted to re-enroll at a
             later date (at least 6 weeks after the resolution of the respiratory tract infection).

          -  Patients who, in the judgment of the investigator or the responsible Novartis
             personnel, have a clinically relevant laboratory abnormality or a clinically
             significant condition such as (but not limited to) unstable ischemic heart disease,
             cancers, left ventricular failure, long term prednisone therapy, history of myocardial
             infarction, arrhythmia (all), narrow angle glaucoma, symptomatic prostatic hyperplasia
             or bladder-neck obstruction or moderate to severe renal impairment.

          -  Patients with a history of asthma indicated by (but not limited to):

               1. Blood eosinophil count > 400/mm3

               2. Onset of symptoms prior to age 40 years.

        Other protocol-defined inclusion/exclusion criteria may apply