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

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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

Tracking Information
First Submitted Date  ICMJE October 25, 2010
First Posted Date  ICMJE November 1, 2010
Results First Submitted Date  ICMJE March 24, 2014
Results First Posted Date  ICMJE December 10, 2014
Last Update Posted Date June 30, 2016
Study Start Date  ICMJE May 2007
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2014)
Maximum Change From Baseline in Airway Blood Flow (Qaw) [ Time Frame: maximum change in Qaw within 240 minutes post drug inhalation ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 29, 2010)
  • airway blood flow (Qaw) [ Time Frame: immediately after inhalation of salmeterol ]
    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 ]
    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 ]
    Qaw will be measured before and at 5, 15, 30, 60, 120, and 240 min after inhalation of fluticasone/salmeterol
Change History Complete list of historical versions of study NCT01231230 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2010)
  • Spirometry [ Time Frame: immediately after inhalation of salmeterol ]
    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 ]
    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 ]
    Spirometry will be measured before and at 5, 15, 30, 60, 120, and 240 min after inhalation of fluticasone
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: fluticasone
    220- mcg once
    Other Name: flovent
  • Drug: placebo inhalation
    placebo inhalation once
    Other Name: sugar pill
  • Drug: Salmeterol
    50 mcg salmeterol once
    Other Name: serevent
  • Drug: fluticasone/salmeterol
    inhalation of 250 mcg of fluticasone combined with 50 mcg of salmeterol
    Other Name: advair
Study Arms  ICMJE
  • Experimental: fluticasone/salmeterol
    participants were treated fluticasone/salmeterol,
    Intervention: Drug: fluticasone/salmeterol
  • Experimental: salmeterol
    participants were treated with salmeterol
    Intervention: Drug: Salmeterol
  • Experimental: fluticasone
    participants were treated with fluticasone
    Intervention: Drug: fluticasone
  • Placebo Comparator: placebo inhalation
    participants were treated with placebo
    Intervention: Drug: placebo inhalation
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):1184-1189. doi: 10.1378/chest.11-0685. 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
Actual Enrollment  ICMJE
 (submitted: December 3, 2014)
14
Original Actual Enrollment  ICMJE
 (submitted: October 29, 2010)
20
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01231230
Other Study ID Numbers  ICMJE 20060346
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Adam Wanner, University of Miami
Study Sponsor  ICMJE University of Miami
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Principal Investigator: Adam Wanner, MD University of Miami
PRS Account University of Miami
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP