Status:
COMPLETED
Efficacy, Tolerability and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
This study will assess the efficacy, tolerability and safety of NVA237 compared to tiotropium when added on to fluticasone/salmeterol in patients with chronic obstructive pulmonary disease.
Eligibility Criteria
Inclusion
- Patients with Moderate to Severe COPD (Stage II or Stage III) according to the GOLD 2010 guideline
- Current or ex-smokers who have a smoking history of at least 10 pack years
- Qualifying FEV1 at Visit 2 (day -7)
Exclusion
- Patients with a history of asthma or a history of high blood eosinophil count (\>600/mm³)
- Patients with concomitant pulmonary disease
- Patients with lung lobectomy or lung volume reduction or lung transplantation
- Patients with α-1 antitrypsin deficiency
- Patients who have had live attenuated vaccinations within 30 days prior to screening visit or during run-in period
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
773 Patients enrolled
Trial Details
Trial ID
NCT01513460
Start Date
April 1 2012
End Date
December 1 2013
Last Update
January 5 2015
Active Locations (71)
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1
Novartis Investigative Site
Baulkham Hills, New South Wales, Australia, 2153
2
Novartis Investigative Site
Brookvale, New South Wales, Australia, 2100
3
Novartis Investigative Site
Castle Hill, New South Wales, Australia, 2067
4
Novartis Investigative Site
Dapto, New South Wales, Australia