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
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: fluticasone Drug: placebo inhalation Drug: Salmeterol Drug: fluticasone/salmeterol||Not Applicable|
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.
- Males and females, 18 to 65 years of age.
- FEV1 60-85% of predicted on the screening day.
- 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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|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|
participants were treated fluticasone/salmeterol,
inhalation of 250 mcg of fluticasone combined with 50 mcg of salmeterol
Other Name: advair
participants were treated with salmeterol
50 mcg salmeterol once
Other Name: serevent
participants were treated with 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
- Maximum Change From Baseline in Airway Blood Flow (Qaw) [ Time Frame: maximum change in Qaw within 240 minutes post drug inhalation ]
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
|Principal Investigator:||Adam Wanner, MD||University of Miami|