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

University of Miami

Status: Completed

Conditions: Asthma

Treatments: Drug: fluticasone; Drug: placebo inhalation; Drug: Salmeterol; Drug: fluticasone/salmeterol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01231230

20060346

Details and patient eligibility

About

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.

Full 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

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

Enrollment: 14 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

14 participants in 4 patient groups, including a placebo group

fluticasone/salmeterol

Experimental group

Description:

participants were treated fluticasone/salmeterol,

Treatment:

Drug: fluticasone/salmeterol

salmeterol

Experimental group

Description:

participants were treated with salmeterol

Treatment:

Drug: Salmeterol

fluticasone

Experimental group

Description:

participants were treated with fluticasone

Treatment:

Drug: fluticasone

placebo inhalation

Placebo Comparator group

Description:

participants were treated with placebo

Treatment:

Drug: placebo inhalation