A Multi-Centered Study of the Long-Term Effect of Salmeterol and Albuterol in Cystic Fibrosis

• Status: Suspended
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Center for Research Resources (NCRR)
• Treatments: Albuterol; Salmeterol Xinafoate

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