Status:
COMPLETED
Comparison of the Effects of Indacaterol and Tiotropium on Inspiratory Capacity
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
This study compared the effects of a single dose of indacaterol with that of a single dose of tiotropium on inspiratory capacity.
Eligibility Criteria
Inclusion
- Diagnosis of moderate (as classified by the Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] Guidelines, 2007) chronic obstructive pulmonary disease (COPD) and:
- Smoking history of at least 10 pack-years.
- Forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 50% of the predicted normal value.
- Post-bronchodilator FEV1/Force vital capacity (FVC) \< 0.7.
Exclusion
- Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment or antibiotics and/or hospitalization in the 6 weeks prior to screening.
- Patients who have had a respiratory tract infection within 6 weeks prior to screening.
- Patients with concomitant pulmonary disease.
- Patients with alpha-1-antitrypsin deficiency.
- Patients with contraindications for tiotropium treatment.
- Patients with a history of hypersensitivity to any of the study drugs or to drugs from similar drug classes.
- Other protocol-defined inclusion/exclusion criteria applied to the study.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00999908
Start Date
October 1 2009
End Date
March 1 2010
Last Update
February 17 2016
Active Locations (11)
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1
Novartis Investigative Site
Bergamo, Italy
2
Novartis Investigative Site
Brescia, Italy
3
Novartis Investigative Site
Cava de' Tirreni, Italy
4
Novartis Investigative Site
Genova, Italy