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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00215436 |
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Date of registration:
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13/09/2005 |
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Primary sponsor: |
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Public title:
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A Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate in the Treatment of Patients With COPD
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Scientific title:
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A 12-week Double-Blind, Parallel-Group, Placebo- and Active- Controlled Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate Inhalation Solution 20 Mcg in the Treatment of Patients With Chronic Obstructive Pulmonary Disease |
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Date of first enrolment:
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March 2005 |
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Target sample size:
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345 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00215436 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Medical diagnosis of COPD
- Current or prior history of cigarette smoking
Exclusion Criteria:
- Medical diagnosis of asthma
- Chest X-ray diagnostic of significant disease other than COPD
- Significant condition or disease other than COPD
Age minimum:
40 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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COPD
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Intervention(s)
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Drug: Formoterol Fumarate
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Primary Outcome(s)
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Measure of lung function
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Secondary Outcome(s)
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Change in lung function, as well as vital signs
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Physical Exam results, Adverse event reporting, etc
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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