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| Sponsored by: |
National Center for Research Resources (NCRR) |
|---|---|
| Information provided by: | National Center for Research Resources (NCRR) |
| ClinicalTrials.gov Identifier: | NCT00005110 |
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 |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
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 |
Inclusion Criteria:
Contacts and Locations More Information
| Study ID Numbers: | NCRR-M01RR00036-5074, M01RR00036 |
| Study First Received: | April 13, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00005110 History of Changes |
| Health Authority: | United States: Federal Government |
|
Neurotransmitter Agents Salmeterol Adrenergic beta-Agonists Adrenergic Agents Fibrosis Albuterol Anti-Asthmatic Agents Adrenergic Agonists Digestive System Diseases |
Cystic Fibrosis Respiratory Tract Diseases Genetic Diseases, Inborn Lung Diseases Pancreatic Diseases Infant, Newborn, Diseases Peripheral Nervous System Agents Bronchodilator Agents |
|
Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Fibrosis Albuterol Physiological Effects of Drugs Reproductive Control Agents Adrenergic Agonists Pathologic Processes Respiratory Tract Diseases Tocolytic Agents Therapeutic Uses |
Infant, Newborn, Diseases Salmeterol Adrenergic beta-Agonists Anti-Asthmatic Agents Pharmacologic Actions Digestive System Diseases Genetic Diseases, Inborn Cystic Fibrosis Autonomic Agents Lung Diseases Pancreatic Diseases Peripheral Nervous System Agents Bronchodilator Agents |
