Efficacy, Safety and Tolerability of NVA237 in Patients With Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: NVA237; Placebo
Intervention description: Delivered via a single dose dry powder inhaler; Delivered via a single dose dry powder inhaler
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: 460.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic obstructive pulmonary disease (COPD); NVA237

Summary:

      This study will assess of the efficacy and safety of a once-daily, 50µg inhalation of NVA237
      in moderate to severe chronic obstructive pulmonary disease (COPD) patients over 26 weeks
      treatment.
    

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

          -  With moderate to severe stable COPD (Stage II or Stage III).

          -  Current or ex-smokers who have a smoking history of at least 10 pack years (Ten pack-
             years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20
             years).

          -  Post-bronchodilator FEV1 ≥30% and < 80% of the predicted normal, and
             post-bronchodilator FEV1/FVC < 0.7 at Visit 2 (Day -14) (post means: record FEV1 and
             FVC 45 min after administering ipratropium).

          -  Symptomatic 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

        Exclusion Criteria:

          -  With a history of malignancy of any organ system (including lung cancer), 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 any history of asthma indicated by (but not limited to) a blood
             eosinophil count > 600/mm3 (at Visit 2) or onset of symptoms prior to age 40 years.
             Patients without asthma but who have a blood eosinophil count >600/mm3 at Visit 2 are
             excluded.

          -  Patients with concomitant pulmonary disease, e.g. pulmonary tuberculosis (unless
             confirmed by imaging to be no longer active) or clinically significant bronchiectasis,
             sarcoidosis and interstitial lung disorder.

          -  Patients with lung lobectomy or lung volume reduction or lung transplantation.

          -  Patients with known history and diagnosis of α-1 antitrypsin deficiency.

          -  Patients who have had a COPD exacerbation that required treatment with antibiotics,
             systemic steroids (oral or intravenous) or hospitalization in the 6 weeks prior to
             Visit 1 Patients who have had a respiratory tract infection within 6 weeks prior to
             Visit 1.

        Other protocol-defined inclusion/exclusion criteria may apply.