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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT00005110
Other study ID # NCRR-M01RR00036-5074
Secondary ID M01RR000036
Status Suspended
Phase N/A
First received April 13, 2000
Last updated June 23, 2005

Study information

Verified date November 2001
Source National Center for Research Resources (NCRR)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Suspended
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 5 Years to 45 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Salmeterol

Albuterol


Locations

Country Name City State
United States Division of Allergy and Pulmonary Medicine St. Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

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