Health Condition 1: null- Chronic Obstructive Pulmonary Disease
Conditions
Interventions
Intervention1: Experimental: NVA237
NVA237 50 µg inhalation capsules o.d., delivered via single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturers proprietary
Sponsors
Novartis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients with moderate to severe stable COPD (Stage II or Stage III) according to the current GOLD Guidelines (GOLD 2010). 2.Patients with a post-bronchodilator FEV1 greater than equal to 30 percent and less than 80 percent of the predicted normal, and a post-bronchodilator FEV1or FVC less than 0.70 at screening 3.Current or ex-smokers who have a smoking history of at least 10 pack years (e.g. 10 pack years equal to 1 pack per day into 10 yrs, or half pack per day into 20 yrs). 4.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
Exclusion criteria: 1.Pregnant or nursing (lactating) women 2.Patients who, in the judgment of the investigator, or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition before Visit 1. 3.Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention. (BPH patients who are stable on treatment can be considered). 4.Patients receiving medications in the classes listed in the protocol as prohibited
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Trough Forced Expiratory Volume in 1 Second (FEV1)Timepoint: Trough Forced Expiratory Volume in 1 Second (FEV1) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Transition Dyspnea Index (TDI) Focal Score 2.The mean change from baseline in the daily number of puffs of rescue medication 3.The mean change from baseline in the daytime number of puffs of rescue medication. 4.The mean change from baseline in the nighttime number of puffs of rescue medicationTimepoint: 1.12 weeks 2.12 weeks 3.12 weeks 4.12 weeks | — |
Countries
Argentina, Canada, Croatia, Czech Republic, Dominican Republic, Estonia, France, Germany, India, Latvia, Lithuania, Philippines, Poland, Republic of Korea, South Africa, Taiwan, Turkey
Contacts
Public ContactMurugananthan K
Novartis Healthcare Private Limited
Outcome results
None listed