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Home > "A" Clinical Trials Conditions > A multi-centered study of the long-term effect of salmeterol and albuterol in cystic fibrosis  A multi-centered study of the long-term effect of salmeterol and albuterol in cystic fibrosis
A multi-centered study of the long-term effect of salmeterol and albuterol in cystic fibrosis
For Condition: Cystic Fibrosis
Status: Suspended
Sponsor(s): National Center for Research Resources (NCRR) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Minimum Age/Maximum Age: 5 Years/45 Years
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Division of Allergy and Pulmonary Medicine
St. Louis, Missouri, 63110
United States
Additional Information:
Study ID Numbers: NCRR-M01RR00036-5074; M01RR00036
Study Start Date:
Record last reviewed: November 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005110
Other Cystic Fibrosis Studies:
1. Quantification of pulmonary neutrophil activity in cystic fibrosis using radiolabeled fluorodeoxyglucose and PET imaging
2. A multi-centered study of the long-term effect of salmeterol and albuterol in cystic fibrosis
3. Weight Gain in CF
4. Study of Tauroursodeoxycholic Acid for Hepatobiliary Disease in Cystic Fibrosis
5. Phase I Randomized Study of Adeno-Associated Virus-CFTR Vector in Patients with Cystic Fibrosis
Related Studies:
Other Cystic Fibrosis Clinical Trials
Other Missouri Clinical Trials
Other St. Louis Clinical Trials
A multi-centered study of the long-term effect of salmeterol and albuterol in cystic fibrosis
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