A Study of the Efficacy and Safety of NVA237 in Patients With Moderate to Severe COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: NVA237; Placebo; Salbutamol
Intervention description: NVA237 capsules for inhalation, delivered via a Single Dose Dry Powder Inhaler (SDDPI) called Concept1; Placebo to NVA237; All patients received salbutamol (100 μg) as only rescue medication
Intervention MeSH terms: Glycopyrrolate; Bromides; Albuterol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 776.0
Sex: All
Minimum age: 41 Years
Maximum age: 84 Years
Healthy volunteers: No
Keywords: Anticholinergic; Antimuscarinic; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease; Chronic Obstructive Pulmonary Disease; COPD; LAMA; Lung Disease; Lung Diseases, Obstructive; Lung Function; Muscarinic receptor antagonist; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases

Summary:

      This study is a post-authorization commitment to the European Medicines Agency (EMA). The
      study serves to determine whether the treatment of patients with stable, symptomatic Chronic
      Obstructive Pulmonary Disease (COPD) with the investigational drug NVA237 is efficient and
      safe. The efficacy and safety of the drug was tested for twice daily dosing against once
      daily dosing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent must be obtained before any assessment is performed

          -  Male and female adults aged ≥40 years

          -  Patients with stable COPD according to the current GOLD strategy (GOLD 2014)

          -  Current or ex-smokers who have a smoking history of at least 10 pack years- an
             ex-smoker may be defined as a subject who has not smoked for ≥ 6 months at screening

          -  mMRC grade of at least 2 at Visit 101

          -  Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥ 30 % and <
             80 % of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70 at Visit 101.

        Exclusion Criteria:

          -  Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
             female after conception and until the termination of gestation, confirmed by a
             positive hCG laboratory test; Women of child-bearing potential, defined as all women
             physiologically capable of becoming pregnant, unless they are using effective methods
             of contraception during dosing of study treatment

          -  Patients with Type I or uncontrolled Type II diabetes; Patients with a history of long
             QT syndrome or whose QTc measured at run-in (Fridericia method) is prolonged (>450 ms
             for males and >460 for females) and confirmed by a central assessor

          -  Patients requiring long term oxygen therapy prescribed for >12 h per day; Patients
             with any history of asthma.