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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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12 December 2016 |
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Main ID: |
NCT00076076 |
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Date of registration:
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13/01/2004 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The FLASH Study: A Study of Roflumilast Versus Placebo in Patients With Asthma (BY217/M2-023)
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Scientific title:
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The FLASH Study: A Randomized, Controlled Study of Roflumilast 250 mcg and 500 mcg Versus Placebo in Patients With Asthma |
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Date of first enrolment:
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December 2003 |
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Target sample size:
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822 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00076076 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Russian Federation
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Ukraine
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United States
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Contacts
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Name:
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AstraZeneca AstraZeneca |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca |
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Key inclusion & exclusion criteria
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Main Inclusion Criteria:
- Diagnosis of persistent chronic bronchial asthma
- Baseline lung function within specified parameters
- No change in asthma treatment during the last 4 weeks prior to start of baseline
period
- Stable clinical state
- Except for asthma, in good health
- Non-smokers or ex-smokers
Main Exclusion Criteria:
- Poorly controlled asthma
- Diagnosis of chronic pulmonary disease and/or other relevant lung diseases
- Patients using continuously (more than 3 days per week) > 8 puffs/day rescue
medication
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Asthma
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Intervention(s)
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Drug: Roflumilast
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Primary Outcome(s)
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change in lung function.
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Secondary Outcome(s)
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asthma symptom score
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rescue medication
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change in morning PEF
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time to withdrawal due to worsening asthma.
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Secondary ID(s)
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BY217/M2-023
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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