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OpenTrials
Completed

NCT Number: NCT01231230

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

  • 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.
  • Cardiovascular disease and/or use of cardiovascular medications
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Fluticasone

Drug

220- mcg once

Other names: flovent

Placebo inhalation

Drug

placebo inhalation once

Other names: sugar pill

Salmeterol

Drug

50 mcg salmeterol once

Other names: serevent

fluticasone/salmeterol

Drug

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

Other names: advair

Primary outcomes

  1. Maximum Change From Baseline in Airway Blood Flow (Qaw)

    Time frame: maximum change in Qaw within 240 minutes post drug inhalation

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • GlaxoSmithKline

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Nov 1, 2010
Registry last updated
Jun 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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