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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00403845 |
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Date of registration:
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24/11/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Dose Ranging Study of Indacaterol in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
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Scientific title:
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A Randomized, Double-blind, Placebo-controlled, 4-period 4-treatment Crossover, Multicenter, Dose-ranging Study to Assess the Efficacy and Safety of 3 Doses of Indacaterol (150, 300, and 600 µg) Delivered Via a Single Dose Dry Powder Inhaler in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD) |
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Date of first enrolment:
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December 2006 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00403845 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Japan
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Contacts
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Name:
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Novartis Pharmaceuticals Japan |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male and female Japanese aged 40 to 75 years old
- Moderate to severe chronic obstructive pulmonary disease (COPD) with smoking history
of at least 20 pack years
Exclusion Criteria:
- History of hospitalization for COPD exacerbation within past 6 months
- Use of long-term oxygen therapy
- History of asthma
- Respiratory tract infection within past 1 month
- Consistently very high or low blood sugar
- Clinically abnormal laboratory values or significant condition
- History of heart failure or heart attack within past 6 months
- History of long QT syndrome or long QT interval in electrocardiogram recorded at
screening
Other protocol-defined inclusion/exclusion criteria applied to the study.
Age minimum:
40 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Obstructive Pulmonary Disease
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Intervention(s)
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Drug: Indacaterol 300 µg
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Drug: Placebo
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Drug: Indacaterol 150 µg
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Primary Outcome(s)
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Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 22 to 24 Hours Post-dose on Day 2
[Time Frame: From 22 to 24 hours post-dose on Day 2]
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Secondary Outcome(s)
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Peak Forced Expiratory Volume in 1 Second (FEV1) From 5 Minutes to 4 Hours Post-dose on Day 1
[Time Frame: From 5 minutes to 4 hours post-dose on Day 1]
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Forced Expiratory Volume in 1 Second (FEV1) by Time Point From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2
[Time Frame: From 5 minutes to 12 hours post-dose on Day 1 and from 22 to 24 hours post-dose on Day 2]
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Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2
[Time Frame: From 5 minutes to 12 hours post-dose on Day 1 and from 22 to 24 hours post-dose on Day 2]
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Secondary ID(s)
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CQAB149B1202
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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