Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01231230
Recruitment Status : Completed
First Posted : November 1, 2010
Results First Posted : December 10, 2014
Last Update Posted : June 30, 2016
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Adam Wanner, University of Miami

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: fluticasone Drug: placebo inhalation Drug: Salmeterol Drug: fluticasone/salmeterol Not Applicable

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


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: Interactive Acute Smooth Muscle Effects of Salmeterol and Fluticasone in the Airway
Study Start Date : May 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: fluticasone/salmeterol
participants were treated fluticasone/salmeterol,
Drug: fluticasone/salmeterol
inhalation of 250 mcg of fluticasone combined with 50 mcg of salmeterol
Other Name: advair

Experimental: salmeterol
participants were treated with salmeterol
Drug: Salmeterol
50 mcg salmeterol once
Other Name: serevent

Experimental: fluticasone
participants were treated with fluticasone
Drug: fluticasone
220- mcg once
Other Name: flovent

Placebo Comparator: placebo inhalation
participants were treated with placebo
Drug: placebo inhalation
placebo inhalation once
Other Name: sugar pill




Primary Outcome Measures :
  1. Maximum Change From Baseline in Airway Blood Flow (Qaw) [ Time Frame: maximum change in Qaw within 240 minutes post drug inhalation ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01231230


Sponsors and Collaborators
University of Miami
GlaxoSmithKline
Investigators
Layout table for investigator information
Principal Investigator: Adam Wanner, MD University of Miami

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Adam Wanner, Professor of Medicine, University of Miami
ClinicalTrials.gov Identifier: NCT01231230     History of Changes
Other Study ID Numbers: 20060346
First Posted: November 1, 2010    Key Record Dates
Results First Posted: December 10, 2014
Last Update Posted: June 30, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Adam Wanner, University of Miami:
asthma, corticosteroids, bronchodilator, airway blood flow
Additional relevant MeSH terms:
Layout table for MeSH terms
Fluticasone
Salmeterol Xinafoate
Fluticasone-Salmeterol Drug Combination
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists