A Crossover Study to Determine the Effect on Lung Function of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control
NCT ID: NCT00615459
Last Updated: 2011-08-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
169 participants
INTERVENTIONAL
2008-02-29
2008-12-31
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
DOUBLE
Study Groups
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Sequence 1: Placebo,Tiotropium, Indacaterol 150 μg
In period I, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. In period II, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via single dose dry powder inhaler (SDDPI). In period III, indacaterol 150 μg once daily delivered via SDDPI and placebo to tiotropium was delivered once daily via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
Indacaterol
Indacaterol 150 μg or 300 μg, delivered via SDDPI
Tiotropium
Tiotropium 18 μg once daily delivered via inhalation device
Placebo
Placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium manufacturer's proprietary inhalation device (HandiHaler®)
Sequence 2: Indacaterol 300 μg, Indacaterol 150 μg, Tiotropium
In period I,indacaterol 300 μg once daily delivered via single dose dry powder inhaler (SDDPI)and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period II, indacaterol 150 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period III, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via SDDPI. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.
Indacaterol
Indacaterol 150 μg or 300 μg, delivered via SDDPI
Tiotropium
Tiotropium 18 μg once daily delivered via inhalation device
Sequence 3: Indacaterol 150 μg, Indacaterol 300 μg, Placebo
In period I, indacaterol 150 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period II, indacaterol 300 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period III, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.
Indacaterol
Indacaterol 150 μg or 300 μg, delivered via SDDPI
Placebo
Placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium manufacturer's proprietary inhalation device (HandiHaler®)
Sequence 4: Tiotropium, Placebo, Indacaterol 300 μg
In period I, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via SDDPI. In period II, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. In period III, indacaterol 300 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.
Indacaterol
Indacaterol 150 μg or 300 μg, delivered via SDDPI
Tiotropium
Tiotropium 18 μg once daily delivered via inhalation device
Placebo
Placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium manufacturer's proprietary inhalation device (HandiHaler®)
Interventions
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Indacaterol
Indacaterol 150 μg or 300 μg, delivered via SDDPI
Tiotropium
Tiotropium 18 μg once daily delivered via inhalation device
Placebo
Placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium manufacturer's proprietary inhalation device (HandiHaler®)
Eligibility Criteria
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Inclusion Criteria
* Co-operative out patients with a diagnosis of chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the Global initiative for chronic obstructive lung disease (GOLD) Guidelines, 2006) and:
1. Smoking history of at least 10 pack years (current or previous smokers)
2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥30% of the predicted normal value.
3. Post-bronchodilator FEV1/Forced vital capacity (FVC) \< 70%
Exclusion Criteria
* Patients requiring long-term oxygen therapy for chronic hypoxemia
* Patients who have had a respiratory tract infection within 6 weeks prior to Visit
* 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
* Any patient with active cancer or a history of cancer with less than 5 years disease free survival time
* Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at Visit 1 or randomization is prolonged
* Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period.
* Patients unable to successfully use a dry powder inhaler device, MDI or perform spirometry measurements
40 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Novartis
Principal Investigators
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Novartis Pharma
Role: STUDY_CHAIR
Novartis Pharmaceuticals
Locations
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Novartis Investigative site
Camperdown, , Australia
Novartis Investigator Site
Gauting, , Germany
Novartis Investigator Site
Großhansdorf, , Germany
Novartis Investigator Site
Mainz, , Germany
Novartis Investigator site
Marburg, , Germany
Novartis Investigator Site
Wiesbaden, , Germany
Novartis Investigator Site
Almelo, , Netherlands
Novartis Investigator Site
Breda, , Netherlands
Novartis Investigator Site
Eindhoven, , Netherlands
Novartis Investigator Site
Harderwijk, , Netherlands
Novartis Investigator Site
Helmond, , Netherlands
Novartis Investigator Site
Wellington, , New Zealand
Novartis Investigator Site
Katowice, , Poland
Novartis Investigator Site
Warsaw, , Poland
Novartis Investigator Site
Durban, , South Africa
Novartis Investigator Site
A Coruña, , Spain
Novartis Investigative site
Alicante, , Spain
Novartis Investigative Site
Cacenes, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigator Site
Ourense, , Spain
Countries
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References
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Vogelmeier C, Ramos-Barbon D, Jack D, Piggott S, Owen R, Higgins M, Kramer B; INTIME study investigators (INdacaterol & TIotropium: Measuring Efficacy). Indacaterol provides 24-hour bronchodilation in COPD: a placebo-controlled blinded comparison with tiotropium. Respir Res. 2010 Oct 5;11(1):135. doi: 10.1186/1465-9921-11-135.
Other Identifiers
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CQAB149B2331
Identifier Type: -
Identifier Source: org_study_id
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