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

Purpose

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.

Condition	Intervention
Cystic Fibrosis	Drug: Salmeterol Drug: Albuterol

Genetics Home Reference related topics:

cystic fibrosis

MedlinePlus related topics:

Cystic Fibrosis

ChemIDplus related topics:

Albuterol sulfate Albuterol Levalbuterol hydrochloride Levalbuterol tartrate Salmeterol Salmeterol xinafoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Further study details as provided by National Center for Research Resources (NCRR):

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

Ages Eligible for Study:	5 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005110

Locations


United States, Missouri
	Division of Allergy and Pulmonary Medicine
	St. Louis, Missouri, United States, 63110

Sponsors and Collaborators

National Center for Research Resources (NCRR)

More Information

Study ID Numbers:	NCRR-M01RR00036-5074, M01RR00036
First Received:	April 13, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00005110
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Salmeterol

Digestive System Diseases

Genetic Diseases, Inborn

Respiratory Tract Diseases

Cystic Fibrosis

Fibrosis

Lung Diseases

Albuterol

Infant, Newborn, Diseases

Pancreatic Diseases

Cystic fibrosis

Additional relevant MeSH terms:

Respiratory System Agents

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Adrenergic Agents

Adrenergic beta-Agonists

Physiological Effects of Drugs

Anti-Asthmatic Agents

Reproductive Control Agents

Pharmacologic Actions

Adrenergic Agonists

Pathologic Processes

Tocolytic Agents

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Bronchodilator Agents

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	National Center for Research Resources (NCRR)
Information provided by:	National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:	NCT00005110