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

NCT ID: NCT01231230

Last Updated: 2016-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2010-08-31

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

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: DOUBLE

Study Groups

fluticasone/salmeterol

participants were treated fluticasone/salmeterol,

Group Type: EXPERIMENTAL

fluticasone/salmeterol

Intervention Type: DRUG

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

salmeterol

participants were treated with salmeterol

Group Type: EXPERIMENTAL

Salmeterol

Intervention Type: DRUG

50 mcg salmeterol once

fluticasone

participants were treated with fluticasone

Group Type: EXPERIMENTAL

fluticasone

Intervention Type: DRUG

220- mcg once

placebo inhalation

participants were treated with placebo

Group Type: PLACEBO_COMPARATOR

placebo inhalation

Intervention Type: DRUG

placebo inhalation once

Interventions

fluticasone

220- mcg once

Intervention Type: DRUG

placebo inhalation

placebo inhalation once

Intervention Type: DRUG

Salmeterol

50 mcg salmeterol once

Intervention Type: DRUG

fluticasone/salmeterol

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

Intervention Type: DRUG

Other Intervention Names

flovent; sugar pill; serevent; advair

Eligibility 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

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Adam Wanner

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adam Wanner, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

References

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.

Reference Type: DERIVED

PMID: 21980058 (View on PubMed)

Other Identifiers

20060346

Identifier Type: -

Identifier Source: org_study_id