Efficacy, Safety and Pharmacokinetics of Different Regimens of Indacaterol
NCT ID: NCT01156844
Last Updated: 2011-08-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
191 participants
INTERVENTIONAL
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
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Indacaterol 37.5 µg (twice a day)
Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days.
All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Indacaterol
Indacaterol inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for 16 days. Dosage and frequency varied according to randomization scheme.
Indacaterol 75 µg (once a day)
Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days.
All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Indacaterol
Indacaterol inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for 16 days. Dosage and frequency varied according to randomization scheme.
Placebo to Indacaterol
Placebo inhaled via Concept1, a SDDPI. Frequency varied according to randomization scheme.
Indacaterol 150 µg (every other day)
Indacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days.
All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Indacaterol
Indacaterol inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for 16 days. Dosage and frequency varied according to randomization scheme.
Placebo to Indacaterol
Placebo inhaled via Concept1, a SDDPI. Frequency varied according to randomization scheme.
Placebo
Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days.
All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Placebo to Indacaterol
Placebo inhaled via Concept1, a SDDPI. Frequency varied according to randomization scheme.
Interventions
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Indacaterol
Indacaterol inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for 16 days. Dosage and frequency varied according to randomization scheme.
Placebo to Indacaterol
Placebo inhaled via Concept1, a SDDPI. Frequency varied according to randomization scheme.
Eligibility Criteria
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Inclusion Criteria
* Receiving daily treatment with inhaled corticosteroid in a regimen that has been stable for at least a month prior to screening
* FEV1 ≥50% and ≤90% of predicted normal at screening
* An increase of ≥12% and ≥200 mL in FEV1 over prebronchodilator value within 30 minutes after inhaling a total dose of albuterol/salbutamol of 360/400 MDI
Exclusion Criteria
* Patients with a diagnosis of COPD
* Patients who have been previously intubated for a severe asthma exacerbation/ attack
* Patients who have experienced a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to screening
* Patients who have had an emergency room visit for an asthma attack/exacerbation within 6 weeks prior to screening
* Patients who have had a respiratory tract infection within 6 weeks prior to screening
* Patients with seasonal allergy whose asthma is likely to deteriorate during the study period
* Patients with Type I or uncontrolled Type II diabetes mellitus
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Novartis Pharmaceuticals
Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Anniston, Alabama, United States
Novartis Investigative Site
Cypress, California, United States
Novartis Investigative Site
Fresno, California, United States
Novartis Investigative Site
San Diego, California, United States
Novartis Investigative Site
Denver, Colorado, United States
Novartis Investigative Site
Clearwater, Florida, United States
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Sarasota, Florida, United States
Novartis Investigative Site
Tampa, Florida, United States
Novartis Investigative Site
Normal, Illinois, United States
Novartis Investigative Site
Lafayette, Louisiana, United States
Novartis Investigative Site
Las Vegas, Nevada, United States
Novartis Investigative Site
Berlin, New Jersey, United States
Novartis Investigative Site
Raleigh, North Carolina, United States
Novartis Investigator Site
Oklahoma City, Oklahoma, United States
Novartis Investigative Site
Houston, Texas, United States
Novartis Investigative Site
Plano, Texas, United States
Novartis Investigative Site
San Antonio, Texas, United States
Novartis Investigative Site
Tacoma, Washington, United States
Novartis Investigative Site
Tacoma, Washington, United States
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Rennes, , France
Novartis Investigative Site
Wiesbaden, , Germany
Novartis Investigative Site
Amman, , Jordan
Novartis Investigative Site
Irbid, , Jordan
Novartis Investigative Site
Groningen, , Netherlands
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
Manchester, , United Kingdom
Novartis Investigative Site
Merthyr Tydfil, , United Kingdom
Countries
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Other Identifiers
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2010-018481-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CQAB149B2223
Identifier Type: -
Identifier Source: org_study_id
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