Chronic obstructive pulmonary disease
Conditions
Interventions
investigational material(s)
Generic name etc : NVA237
INN of investigational material :
Therapeutic category code : 225 Bronchodilators
Dosage and Administration for Investigational material : 50 mcg
Sponsors
Novartis Pharma K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with moderate to severe stable COPD Stage II or Stage III) according to the Gold Guideline 2008. Current or ex-smokers who have a smoking history of at least 10 pack years. Patients with a post-bronchodilator FEV1 >= 30% and < 80% of the predicted normal, and postbronchodilator FEV1/FVC < 0.7
Exclusion criteria
Exclusion criteria: Pregnant women or nursing mothers or women of child-bearing potential not using an acceptable method of contraception Patients requiring long term oxygen therapy Patients who have had a lower respiratory tract infection within 6 weeks prior to Visit 1 Patients with concomitant pulmonary disease Patients with a history of asthma Any patient with lung cancer or a history of lung cancer Patients with a history of certain cardiovascular comorbid conditions Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency Patients in the active phase of a supervised pulmonary rehabilitation program Patients contraindicated for tiotropium or ipratropium treatment or who have shown an untoward reaction to inhaled anticholinergic agents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of NVA237 with regard to adverse events Adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of NVA237 with regard to ECGs, vital signs and laboratory tests ECGs, vital signs and laboratory tests Efficacy of NVA237 assessed by pre-dose FEV1 and FVC Pre-dose FEV1 and FVC Time to first moderate to severe COPD exacerbation Time to first moderate to severe COPD exacerbation | — |
Outcome results
None listed