N/A
N=14
Interactive Acute Smooth Muscle Effects of Salmeterol and Fluticasone in the Airway
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT01231230 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Maximum Change From Baseline in Airway Blood Flow (Qaw) — -11.0; 14.1; 23.9; 25.5 change from baseline ( µl/min/ml) — p=< 0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- fluticasone (Drug); placebo inhalation (Drug); Salmeterol (Drug); fluticasone/salmeterol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Change From Baseline in Airway Blood Flow (Qaw) |
-11.0; 14.1; 23.9; 25.5 | < 0.001 sig |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Males and females, 18 to 65 years of age.
- FEV1 60-85% of predicted on the screening day. -
Exclusion Criteria
- 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 3. 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
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Data sourced from ClinicalTrials.gov (NCT01231230). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.