Interactive Acute Smooth Muscle Effects of Salmeterol and Fluticasone in the Airway

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Drug: fluticasone/salmeterol; Drug: placebo inhalation; Drug: Salmeterol; Drug: fluticasone

• Registration Number: NCT01231230
• Lead Sponsor: University of Miami

Brief 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.

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

Study Timeline

• Study Start: 2007-05
• Primary Completion: 2009-12
• Study Completion: 2010-08
• Study First Submitted: 2010-10-25
• Study First Submitted QC: 2010-10-29
• Study First Posted: 2010-11-01
• Results First Submitted: 2014-03-24
• Results First Submitted QC: 2014-12-03
• Results First Posted: 2014-12-10
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-27
• Last Update Posted: 2016-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
fluticasone/salmeterol	fluticasone/salmeterol	participants were treated fluticasone/salmeterol,
placebo inhalation	placebo inhalation	participants were treated with placebo
salmeterol	Salmeterol	participants were treated with salmeterol
fluticasone	fluticasone	participants were treated with fluticasone

Primary Outcome Measures

Name	Time	Method
Maximum Change From Baseline in Airway Blood Flow (Qaw)	maximum change in Qaw within 240 minutes post drug inhalation