Status:
COMPLETED
Exacerbation Study
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
This study compares indacaterol with tiotropium in terms of bronchodilation over 52 weeks
Eligibility Criteria
Inclusion
- Male and female adults aged ≥40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure
- Patients diagnosed with COPD at age 40 and over and with a current diagnosis of severe COPD and including:
- Smoking history of at least 10 pack years, both current and ex-smokers are eligible
- A documented history of at least 1 moderate or severe exacerbation in the previous 12 months
Exclusion
- Patients who have received systemic corticosteroids and/or antibiotics for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period
- Patients who have had a respiratory tract infection within 6 weeks prior to screening
- Patients with concomitant pulmonary disease
- Patients with a history of asthma
- Patients with diabetes Type I or uncontrolled diabetes Type II
- Any patient with lung cancer or a history of lung cancer
- Patients with a history of certain cardiovascular comorbid conditions
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
3439 Patients enrolled
Trial Details
Trial ID
NCT00845728
Start Date
March 1 2009
End Date
July 1 2012
Last Update
November 19 2013
Active Locations (423)
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1
Novartis Investigative Site
Buenos Aires, Buenos Aires, Argentina, 5000
2
Novartis Investigative Site
Buenos Aires, Buenos Aires, Argentina, B1842DID
3
Novartis Investigative Site
Buenos Aires, Buenos Aires, Argentina, C1122AAK
4
Novartis Investigative Site
Buenos Aires, Buenos Aires, Argentina, C1125ABE