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

This study has been completed.

Sponsor:

Collaborator:

GlaxoSmithKline

Information provided by:

University of Miami

ClinicalTrials.gov Identifier:

NCT01231230

First received: October 25, 2010

Last updated: October 29, 2010

Last verified: October 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	October 25, 2010
Last Updated Date	October 29, 2010
Start Date ^ICMJE	May 2007
Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 29, 2010)	airway blood flow (Qaw) [ Time Frame: immediately after inhalation of salmeterol ] [ Designated as safety issue: No ] Qaw will be measured before and at 5, 15, 30, 60, 120, and 240 min after inhalation of salmeterol Airway Blood Flow (Qaw) [ Time Frame: immediately after inhalation of fluticasone ] [ Designated as safety issue: No ] Qaw will be measured before and at 5, 15, 30, 60, 120, and 240 min after inhalation of fluticasone Airway Blood Flow (Qaw) [ Time Frame: immediately after inhalation of fluticasone/salmeterol ] [ Designated as safety issue: No ] Qaw will be measured before and at 5, 15, 30, 60, 120, and 240 min after inhalation of fluticasone/salmeterol
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01231230 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 29, 2010)	Spirometry [ Time Frame: immediately after inhalation of salmeterol ] [ Designated as safety issue: No ] Spirometry will be measured before and at 5, 15, 30, 60, 120, and 240 min after inhalation of salmeterol spirometry [ Time Frame: immediately after inhalation of fluticasone/salmeterol ] [ Designated as safety issue: No ] Spirometry will be measured before and at 5, 15, 30, 60, 120, and 240 min after inhalation of fluticasone/salmeterol Spirometry [ Time Frame: immediately after inhalation of fluticasone ] [ Designated as safety issue: No ] Spirometry will be measured before and at 5, 15, 30, 60, 120, and 240 min after inhalation of fluticasone
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Interactive Acute Smooth Muscle Effects of Salmeterol and Fluticasone in the Airway
Official Title ^ICMJE	Interactive Acute Smooth Muscle Effects of Salmeterol and Fluticasone in the Airway
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	Twenty lifetime nonsmokers with a physician diagnosis of asthma will be recruited for the study. Ten of them will be subjects who do not use inhaled glucocorticosteroids and/or regular long-acting beta-adrenergic agonists, and 10 will be subjects who have been using salmeterol/fluticasone (50/250 μg) regularly twice a day as a controller for at least 4 weeks. 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 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
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator)
Condition ^ICMJE	Asthma
Intervention ^ICMJE	Drug: fluticasone 220- mcg once Drug: placebo inhalation placebo inhalation once Drug: Salmeterol 50 mcg salmeterol once Drug: Salmeterol 50 mcg once Drug: fluticasone/salmeterol inhalation of 250 mcg of fluticasone combined with 50 mcg of salmeterol
Study Arm (s)	Active Comparator: fluticasone inhalation of 250 mcg of fluticasone Intervention: Drug: fluticasone Placebo Comparator: placebo inhalation of placebo diskus Intervention: Drug: placebo inhalation Active Comparator: salmeterol inhalation of salmeterol 50 mcg once Interventions: Drug: Salmeterol Drug: Salmeterol Active Comparator: fluticasone/salmeterol inhalation of fluticasone 250mcg combined with salmeterol 50 mcg Intervention: Drug: fluticasone/salmeterol
Publications *	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):1184-9. Epub 2011 Oct 6.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	20
Completion Date	August 2010
Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Males and females, 18 to 65 years of age. 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 -
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01231230
Other Study ID Numbers ^ICMJE	20060346
Has Data Monitoring Committee	No
Responsible Party	Adam Wanner, MD, University of Miami
Study Sponsor ^ICMJE	University of Miami
Collaborators ^ICMJE	GlaxoSmithKline
Investigators ^ICMJE	Not Provided
Information Provided By	University of Miami
Verification Date	October 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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