A Multi-Centered Study of the Long-Term Effect of Salmeterol and Albuterol in Cystic Fibrosis
2 other identifiers
interventional
N/A
1 country
1
Brief Summary
Long term use of bronchodilators in CF is beneficial to the improvement of pulmonary function and symptoms. This study is investigating the long-term benefit of administration of the drug Salmeterol, a bronchodilator. Salmeterol will be compared to albuterol or placebo. The medication will be inhaled twice a day for 6 months.
Trial Health
Trial Health Score
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1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2000
CompletedFirst Posted
Study publicly available on registry
April 14, 2000
CompletedJune 24, 2005
November 1, 2001
April 13, 2000
June 23, 2005
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- Ability to perform reproducible spirometry
- FEVI \> 50% and \< 90% (Knudsen)
- A CF pulmonary exacerbation within the last year or an FEVI\<80%
- At least one delta f508 allele on CF mutation analysis
- Ability to demonstrate use of inhaled medicine and FEVI and PEFR monitor
- Written informed consent
- Negative serum pregnancy test on enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Allergy and Pulmonary Medicine
St Louis, Missouri, 63110, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
April 13, 2000
First Posted
April 14, 2000
Last Updated
June 24, 2005
Record last verified: 2001-11