Asthma Clinical Trial
Official title:
Interactive Acute Smooth Muscle Effects of Salmeterol and Fluticasone in the Airway
The addition of an inhaled long-acting beta-adrenergic agonist to an inhaled glucocorticosteroid improves disease control in persistent asthma. This observation has supported the use of long-acting beta-adrenergic agonist/glucocorticosteroid combination preparations for the management of asthma. Currently, salmeterol/fluticasone and formoterol/budesonide are available for clinical use. The long-term beneficial clinical effects of the two drug classes seem to be synergistic, and several mechanisms of glucocorticoid-beta-adrenergic agonist interactions involving gene transcription have been invoked to explain this phenomenon.This study, wish to address the question whether glucocorticoids can acutely potentiate the bronchodilator response to a long-acting beta-adrenergic agonist.We expect that in patients with asthma, the short-term bronchodilator effect of salmeterol is enhanced by the addition of fluticasone, which by itself has no short-term bronchodilator effect. To test this premise, we will assess the respective short-term effects of salmeterol (50 µg), fluticasone (250 µg), salmeterol/fluticasone (50/250 µg), and placebo/placebo on spirometric parameters. Airway Blood flow will also be measured to ensure that vasoconstriction does not occur.
Fourteen lifetime nonsmokers with a physician diagnosis of asthma will be recruited for the
study. All subjects will be allowed to use short-acting beta-adrenergic agonists as rescue
medication.
Inclusion criteria:
1. Males and females, 18 to 65 years of age.
2. FEV1 60-85% of predicted on the screening day.
Exclusion criteria:
1. Women of childbearing potential who do not use accepted birth control measures;
pregnant and breast feeding women.
2. Cardiovascular disease and/or use of cardiovascular medications
2. Subjects with known beta-adrenergic agonist or glucocorticosteroid intolerance 4. Acute
respiratory infection within four weeks prior to the study 5. Use, within two weeks prior to
the study, of any anti-asthma medication not mentioned above
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
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