1-year Study to Assess the Efficacy, Safety, and Tolerability of Glycopyrronium Bromide (NVA237) in Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Glycopyrronium bromide; Placebo to glycopyrronium bromide; Tiotropium
Intervention description: Glycopyrronium bromide was supplied in powder-filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.; Placebo to glycopyrronium bromide was supplied in powder-filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.; Tiotropium was supplied in powder-filled capsules together with the Handihaler® device.
Intervention MeSH terms: Glycopyrrolate; Bromides; Tiotropium Bromide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1066.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; NVA237; glycopyrronium bromide

Summary:

      This study was designed to investigate the 1 year efficacy and safety of the 50 µg once daily
      (od) dose of glycopyrronium bromide (NVA237) in patients with moderate to severe chronic
      obstructive pulmonary disease.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female adults aged ≥ 40 years, who have signed an Informed Consent Form prior
             to initiation of any study-related procedure.

          2. Patients with moderate to severe stable chronic obstructive pulmonary disease (COPD,
             Stage II or Stage III) according to the Global Initiative for Chronic Obstructive Lung
             Disease (GOLD) Guidelines 2008.

          3. Current or ex-smokers who have a smoking history of at least 10 pack years.

          4. 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 (Day -14).

          5. Patients, according to daily electronic diary data between Visit 2 (Day -14) and Visit
             3 (Day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to
             Visit 3 (Day 1).

        Exclusion Criteria:

          1. Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy
             test).

          2. Women of child-bearing potential, unless using an approved method of medical or
             surgical contraception.

          3. Patients requiring long term oxygen therapy (> 15 h a day) 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 (Day -21) or between Visit 1 (Day -21) and
             Visit 3 (Day 1).

          4. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1
             (Day -21).

          5. Patients who, in the judgment of the investigator or the responsible Novartis
             personnel, have a clinically relevant laboratory abnormality or a clinically
             significant condition.

          6. Patients with any history of asthma indicated by (but not limited to) a blood
             eosinophil count > 600/mm^3 (at Visit 1, Day -21) and onset of symptoms prior to age
             40 years.

          7. Patients with a history of long QT syndrome or whose QTc measured at Visit 1 (Day -21)
             (Fridericia method) is prolonged (> 450 ms for males or > 470 ms for females.

        Other protocol-defined inclusion/exclusion criteria may apply to the study.