Safety and Tolerability of 28 Days Treatment With Glycopyrronium Bromide (NVA237) (100 or 200 µg Once a Day) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: NVA237 100 µg; Placebo; NVA237 200 µg
Intervention description: Dry powder inhalation once a day for up to 28 days; Placebo to NVA237 dry powder inhalation once a day for up to 28 days; Dry powder inhalation once a day for up to 28 days
Intervention MeSH terms: Glycopyrrolate; Bromides
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 281.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; glycopyrronium bromide; antimuscarinic

Summary:

      This study assessed the safety/tolerability of 28 days of treatment with NVA237 100 µg and
      200 µg once a day, compared to placebo in patients with moderate or severe Chronic
      Obstructive Pulmonary Disease (COPD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female adults aged 40 years or older

          -  Patients with moderate to severe COPD according to the GOLD Guidelines (2006)

          -  Patients who have smoking history of at least 10 pack years

          -  Patients with a post-bronchodilator Forced Expiratory Volume in One Second (FEV1)
             equal or greater than 30% of the predicted normal value and less than 80% of the
             predicted normal value, and post-bronchodilator FEV1/FVC less than 0.7 at visit 2

          -  Written informed consent by the patient prior to initiation of any study-related
             procedure

        Exclusion Criteria:

          -  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 during the screening period (up to visit 3).

          -  Patients who have had a respiratory tract infection within 6 weeks prior to visit 1 or
             during the screening period (up to visit 3).

          -  Patients with a history of asthma indicated by (but not limited to):

        Blood eosinophil count > 400/mm3, onset of symptoms prior to age 40 years.

          -  Patients with a history of long QT syndrome or whose QTc measured at visit 1 is
             prolonged (more than 440 ms for males or more than 460 ms for females).

          -  Patients with a history of untoward reactions to sympathomimetic amines or inhaled
             medication or any component thereof.

          -  Patients who, in the judgment of the investigator have a clinically relevant
             laboratory abnormality or a clinically significant condition such as (but not limited
             to) unstable ischemic heart disease, left ventricular failure, long term prednisone
             therapy, history of myocardial infarction, arrhythmia, narrow-angle glaucoma,
             symptomatic prostatic hyperplasia, bladder-neck obstruction or moderate to severe
             renal impairment that might compromise patient safety or compliance, interfere with
             evaluation, or preclude completion of the study.

          -  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.

        Other protocol-defined inclusion/exclusion criteria may apply