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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00624286




Registration number
NCT00624286
Ethics application status
Date submitted
15/02/2008
Date registered
15/02/2008
Date last updated
22/07/2011

Titles & IDs
Public title
Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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
Secondary ID [1] 0 0
EUDRACT Number: 2008-000301-11
Secondary ID [2] 0 0
CQAB149B2346
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85) - 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.
Timepoint [1] 0 0
24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)
Secondary outcome [1] 0 0
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2 - 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.
Timepoint [1] 0 0
24 hours post-dose on Day 2

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%
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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United States of America
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Alabama
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California
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Colorado
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Delaware
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Florida
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Georgia
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Illinois
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Indiana
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Louisiana
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Montana
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Nebraska
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Nevada
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New Jersey
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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West Virginia
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Wisconsin
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Belgium
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Lanaken
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New Zealand
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Tauranga

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/show/NCT00624286
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Other publications