Interactive Acute Smooth Muscle Effects of Salmeterol and Fluticasone in the Airway
Information source: University of Miami
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: fluticasone (Drug); placebo inhalation (Drug); Salmeterol (Drug); fluticasone/salmeterol (Drug)
Phase: N/A
Status: Completed
Sponsored by: University of Miami Official(s) and/or principal investigator(s): Adam Wanner, MD, Principal Investigator, Affiliation: University of Miami
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.
Clinical Details
Official title: Interactive Acute Smooth Muscle Effects of Salmeterol and Fluticasone in the Airway
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
Primary outcome: Maximum Change From Baseline in Airway Blood Flow (Qaw)
Detailed description:
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
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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 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
-
Locations and Contacts
Additional Information
Starting date: May 2007
Last updated: December 3, 2014
|