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

Tracking Information
First Received Date ^ICMJE	April 13, 2000
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00005110 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Multi-Centered Study of the Long-Term Effect of Salmeterol and Albuterol in Cystic Fibrosis
Official Title ^ICMJE
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.
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.
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Condition ^ICMJE	Cystic Fibrosis
Intervention ^ICMJE	Drug: Salmeterol Drug: Albuterol
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Suspended
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	5 Years to 45 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00005110
Responsible Party
Study ID Numbers ^ICMJE	NCRR-M01RR00036-5074, M01RR00036
Study Sponsor ^ICMJE	National Center for Research Resources (NCRR)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Center for Research Resources (NCRR)
Verification Date	November 2001
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP