CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 14 enrolled
Drug / intervention
fluticasone +3 moredrug
Likely dose
Salmeterol 50 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01231230
NCT01231230N/ACompleted

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

University of Miami·interventional·Posted Nov 1, 2010·Updated Jun 30, 2016

In Brief

A clinical study evaluating fluticasone, placebo inhalation, and 2 other interventions for Asthma. Completed, enrolled 14 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
Countries--
CollaboratorsGlaxoSmithKline

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 1, 2010
Enrollment StartMay 1, 2007
Primary CompletionDec 1, 2009
Study CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 15.7 years ago

Interventions

fluticasonedrug

220- mcg once

placebo inhalationdrug

placebo inhalation once

Salmeteroldrug

50 mcg salmeterol once

fluticasone/salmeteroldrug

inhalation of 250 mcg of fluticasone combined with 50 mcg of salmeterol