A Multi-Centered Study of the Long-Term Effect of Salmeterol and Albuterol in Cystic Fibrosis
Information source: National Center for Research Resources (NCRR)
Information obtained from ClinicalTrials.gov on March 24, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cystic Fibrosis
Intervention: Salmeterol (Drug); Albuterol (Drug)
Phase: N/A
Status: Suspended
Sponsored by: National Center for Research Resources (NCRR)
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.
Clinical Details
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Detailed description:
Patients that have been diagnosed with cystic fibrosis and are above 5 years and below 45
years of age are eligible. Subjects will be randomized into 1 of 3 groups. One group will
get Salmeterol by multi-dose inhaler (MDI) 2 puffs 2 times a day, one group will get
albuterol by MDI 2 puffs 2 times a day and the other will get placebo by MDI 2 puffs 2 times
a day. Height and weight along with pulmonary function testing and vital signs will be
monitored at the beginning of the study and at Visits 2, 3, and 4. Peak flow monitoring will
be done each morning before study medication at home. A daily diary will be kept of this
measurement. Subjects will be seen in the research center at visits 1,2,3, and 4. Telephone
contact will be done at Day 15, 60, 120, and 150. Individual outcomes include a potential
increase in pulmonary function testing and a decrease in frequency of pulmonary
exacerbations, hospitalizations, and usage of antibiotics.
Eligibility
Minimum age: 5 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Locations and Contacts
Division of Allergy and Pulmonary Medicine, St. Louis, Missouri 63110, United States
Additional Information
Last updated: June 23, 2005
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