Status:
COMPLETED
1-year Study to Assess the Efficacy, Safety, and Tolerability of Glycopyrronium Bromide (NVA237) in Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Novartis
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
This study was designed to investigate the 1 year efficacy and safety of the 50 µg once daily (od) dose of glycopyrronium bromide (NVA237) in patients with moderate to severe chronic obstructive pulmo...
Eligibility Criteria
Inclusion
- Male or female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
- Patients with moderate to severe stable chronic obstructive pulmonary disease (COPD, Stage II or Stage III) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines 2008.
- Current or ex-smokers who have a smoking history of at least 10 pack years.
- Patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 30% and \< 80% of the predicted normal, and post-bronchodilator FEV1/forced vital capacity (FVC) \< 0.7 at Visit 2 (Day -14).
- 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 (Day 1).
Exclusion
- Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy test).
- Women of child-bearing potential, unless using an approved method of medical or surgical contraception.
- Patients requiring long term oxygen therapy (\> 15 h a day) 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 (Day -21) or between Visit 1 (Day -21) and Visit 3 (Day 1).
- Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1 (Day -21).
- Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition.
- Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count \> 600/mm\^3 (at Visit 1, Day -21) and onset of symptoms prior to age 40 years.
- Patients with a history of long QT syndrome or whose QTc measured at Visit 1 (Day -21) (Fridericia method) is prolonged (\> 450 ms for males or \> 470 ms for females.
- Other protocol-defined inclusion/exclusion criteria may apply to the study.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
1066 Patients enrolled
Trial Details
Trial ID
NCT00929110
Start Date
June 1 2009
End Date
April 1 2011
Last Update
August 17 2012
Active Locations (139)
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1
Novartis Investigative Site
Birmingham, Alabama, United States, 35249
2
Novartis Investigative Site
Mobile, Alabama, United States, 36608
3
Novartis Investigative Site
Montgomery, Alabama, United States, 36117
4
Novartis Investigator Site
Fort Smith, Arkansas, United States, 72901