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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00624286
Registration number
NCT00624286
Ethics application status
Date submitted
15/02/2008
Date registered
27/02/2008
Date last updated
18/08/2011
Titles & IDs
Public title
Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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Scientific title
A 12-week Treatment, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Indacaterol (150 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease
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Secondary ID [1]
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EUDRACT Number: 2008-000301-11
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Secondary ID [2]
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CQAB149B2346
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease
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Condition category
Condition code
Respiratory
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Indacaterol 150 µg
Treatment: Drugs - Placebo to indacaterol
Experimental: Indacaterol 150 µg - Patients inhaled indacaterol 150 µg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting ß2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Placebo comparator: Placebo to indacaterol - Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting ß2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Treatment: Drugs: Indacaterol 150 µg
Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
Treatment: Drugs: Placebo to indacaterol
Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85)
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Assessment method [1]
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FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
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Timepoint [1]
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24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)
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Secondary outcome [1]
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Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2
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Assessment method [1]
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FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
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Timepoint [1]
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24 hours post-dose on Day 2
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Eligibility
Key inclusion criteria
• Male or female patients aged 40 years or over with moderate to severe chronic obstructive pulmonary disease (COPD) plus
* 20 pack-year smoking history
* Signed informed consent
* Post-bronchodilator forced expiratory volume in 1 second )FEV1) = 30% and < 80% predicted FEV1/FVC (forced vital capacity) < 70%
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Minimum age
40
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria include:
* History of asthma
* Prior exposure to indacaterol
* Active cancer or history of cancer
* Patients with concomitant pulmonary disease
* Patients with diabetes Type I or uncontrolled diabetes Type II
* Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at screening or randomization is prolonged
* Patients unable to successfully use a dry-powder inhaler device or perform spirometry measurements
Other protocol-defined inclusion/exclusion criteria applied to the study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2008
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Sample size
Target
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Accrual to date
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Final
416
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Recruitment in Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This study was designed to provide 12 weeks efficacy and safety data of the 150 µg once-daily (od) dose of indacaterol in chronic obstructive pulmonary disease (COPD).
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Trial website
https://clinicaltrials.gov/study/NCT00624286
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Trial related presentations / publications
Jones PW, Donohue JF, Nedelman J, Pascoe S, Pinault G, Lassen C. Correlating changes in lung function with patient outcomes in chronic obstructive pulmonary disease: a pooled analysis. Respir Res. 2011 Dec 29;12(1):161. doi: 10.1186/1465-9921-12-161. Bleecker ER, Siler T, Owen R, Kramer B. Bronchodilator efficacy and safety of indacaterol 150 mug once daily in patients with COPD: an analysis of pooled data. Int J Chron Obstruct Pulmon Dis. 2011;6:431-8. doi: 10.2147/COPD.S21073. Epub 2011 Aug 18. Feldman G, Siler T, Prasad N, Jack D, Piggott S, Owen R, Higgins M, Kramer B; INLIGHT 1 study group. Efficacy and safety of indacaterol 150 microg once-daily in COPD: a double-blind, randomised, 12-week study. BMC Pulm Med. 2010 Mar 8;10:11. doi: 10.1186/1471-2466-10-11.
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Public notes
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Contacts
Principal investigator
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00624286
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