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

NCT01231230 | Completed Results

• 1 other identifier: 20060346
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma

Keywords

asthma, corticosteroids, bronchodilator, airway blood flow

Outcome Measures

Primary Outcomes (1)

• Maximum Change From Baseline in Airway Blood Flow (Qaw)

  maximum change in Qaw within 240 minutes post drug inhalation

Study Arms (4)

fluticasone/salmeterol

EXPERIMENTAL

participants were treated fluticasone/salmeterol,

Drug: fluticasone/salmeterol

salmeterol

EXPERIMENTAL

participants were treated with salmeterol

Drug: Salmeterol

fluticasone

EXPERIMENTAL

participants were treated with fluticasone

Drug: fluticasone

placebo inhalation

PLACEBO COMPARATOR

participants were treated with placebo

Drug: placebo inhalation

Interventions

fluticasone DRUG

220- mcg once

Also known as: flovent

fluticasone

placebo inhalation DRUG

placebo inhalation once

Also known as: sugar pill

placebo inhalation

Salmeterol DRUG

50 mcg salmeterol once

Also known as: serevent

salmeterol

fluticasone/salmeterol DRUG

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

Also known as: advair

fluticasone/salmeterol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females, 18 to 65 years of age.
• FEV1 60-85% of predicted on the screening day. -

You may not qualify if:

• \. 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

Sponsors & Collaborators

• University of Miami: lead
• GlaxoSmithKline: collaborator

Related Publications (1)

• Mendes ES, Rebolledo P, Wanner A. Acute effects of salmeterol and fluticasone propionate alone and in combination on airway blood flow in patients with asthma. Chest. 2012 May;141(5):1184-1189. doi: 10.1378/chest.11-0685. Epub 2011 Oct 6.

  PMID: 21980058 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone; Sugars; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Carbohydrates; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Adam Wanner, MD
• Organization: University of Miami

awanner@med.miami.edu

(305)243-2568

Study Officials

• Adam Wanner, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 25, 2010
• First Posted: November 1, 2010
• Study Start: May 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: August 1, 2010
• Last Updated: June 30, 2016
• Results First Posted: December 10, 2014

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share