Comparison of the Effects of Indacaterol and Tiotropium on Inspiratory Capacity
NCT ID: NCT00999908
Last Updated: 2016-02-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
54 participants
INTERVENTIONAL
2009-10-31
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Indacaterol 150 μg-tiotropium 18 μg-placebo
Patients received indacaterol 150 μg once. After a 5-9 days washout period, patients received tiotropium 18 μg once. After a second 5-9 days washout period, patients received placebo (matching indacaterol) once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
Indacaterol 150 μg
Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Tiotropium 18 μg
Tiotropium was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Placebo
Placebo (matching indacaterol) was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Tiotropium 18 μg-placebo-indacaterol 150 μg
Patients received tiotropium 18 μg once. After a 5-9 days washout period, patients received placebo (matching indacaterol) once. After a second 5-9 days washout period, patients received indacaterol 150 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
Indacaterol 150 μg
Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Tiotropium 18 μg
Tiotropium was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Placebo
Placebo (matching indacaterol) was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Placebo-indacaterol 150 μg-tiotropium 18 μg
Patients received placebo (matching indacaterol) once. After a 5-9 days washout period, patients received indacaterol 150 μg once. After a second 5-9 days washout period, patients received tiotropium 18 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
Indacaterol 150 μg
Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Tiotropium 18 μg
Tiotropium was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Placebo
Placebo (matching indacaterol) was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Interventions
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Indacaterol 150 μg
Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Tiotropium 18 μg
Tiotropium was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Placebo
Placebo (matching indacaterol) was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Eligibility Criteria
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Inclusion Criteria
1. Smoking history of at least 10 pack-years.
2. Forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 50% of the predicted normal value.
3. Post-bronchodilator FEV1/Force vital capacity (FVC) \< 0.7.
Exclusion Criteria
* 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.
40 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Bergamo, , Italy
Novartis Investigative Site
Brescia, , Italy
Novartis Investigative Site
Cava de' Tirreni, , Italy
Novartis Investigative Site
Genova, , Italy
Novartis Investigative Site
Milan, , Italy
Novartis Investigative Site
Orbassano, , Italy
Novartis Investigative Site
Pavia, , Italy
Novartis Investigative Site
Reggio Emilia, , Italy
Novartis Investigative Site
Sesto San Giovanni, , Italy
Novartis Investigative Site
Treviso, , Italy
Novartis Investigative Site
Verona, , Italy
Countries
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References
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Rossi A, Centanni S, Cerveri I, Gulotta C, Foresi A, Cazzola M, Brusasco V. Acute effects of indacaterol on lung hyperinflation in moderate COPD: a comparison with tiotropium. Respir Med. 2012 Jan;106(1):84-90. doi: 10.1016/j.rmed.2011.09.006. Epub 2011 Oct 27.
Other Identifiers
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2009-013763-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CQAB149BIT01
Identifier Type: -
Identifier Source: org_study_id
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