Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 35 of 318 for:    FLUTICASONE AND SALMETEROL

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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator)
Condition Asthma
Interventions Drug: fluticasone
Drug: placebo inhalation
Drug: Salmeterol
Drug: fluticasone/salmeterol
Enrollment 14
Recruitment Details Subjects were recruited from our Asthma Database. Subjects with asthma who are in our database have previously agreed to serve as potential subjects in future studies. These subjects have signed an informed consent (approved by UM IRB) to be included in this database.
Pre-assignment Details  
Arm/Group Title All Study Groups
Hide Arm/Group Description

inhalation of 250 mcg of fluticasone

fluticasone: 220- mcg once

Period Title: Overall Study
Started 14
Fluticasone 14
Salmeterol 14
Fluticasone/Salmeterol 14
Placebo 14
Completed 14
Not Completed 0
Arm/Group Title All Study Participants
Hide Arm/Group Description participant received in random order one of the four treatments ( fluticasone, salmeterol, fluticasone+salmeterol or placebo)
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
Fourteen lifetime nonsmokers with a physician diagnosis of asthma were recruited for the study. All but one of the subjects were using an ICS/LABA combination preparation regularly, and all used a short-acting b2-adrenergic agonist as rescue medication. All subjects had to have a prebronchodilator FEV1 of 60% to 85% predicted .
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
9
  64.3%
Male
5
  35.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  21.4%
White
11
  78.6%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants
14
Airway blood flow (Qaw)   [1] 
Mean (Standard Deviation)
Unit of measure:  µl.min-1.ml-1
Number Analyzed 14 participants
54.8  (2.6)
[1]
Measure Description: Qaw was measured with a previously validated soluble inert gas uptake method. It is based on quantifying the disappearance of the soluble gas dimethylether (DME) from the anatomical dead space. The method involves the inhalation of a gas mixture containing 10 % DME and 90% nitrogen from 500 ml below the total lung capacity position to total lung capacity, followed by a breathhold (5 or 15 sec) and subsequent exhalation while the instantaneous concentrations of DME and nitrogen are recorded.
1.Primary Outcome
Title Maximum Change From Baseline in Airway Blood Flow (Qaw)
Hide Description [Not Specified]
Time Frame maximum change in Qaw within 240 minutes post drug inhalation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluticasone Placebo Salmeterol Fluticasone/Salmeterol
Hide Arm/Group Description:

inhalation of 250 mcg of fluticasone

fluticasone: 220- mcg once

inhalation of placebo diskus

placebo inhalation: placebo inhalation once

inhalation of salmeterol 50 mcg once

Salmeterol: 50 mcg salmeterol once

Salmeterol: 50 mcg once

inhalation of fluticasone 250mcg combined with salmeterol 50 mcg

fluticasone/salmeterol: inhalation of 250 mcg of fluticasone combined with 50 mcg of salmeterol

Overall Number of Participants Analyzed 14 14 14 14
Mean (Standard Error)
Unit of Measure: change from baseline ( µl/min/ml)
-11.0  (2.9) 14.1  (1.9) 23.9  (3.6) 25.5  (4.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone/Salmeterol
Comments mean difference from baseline relative to placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 15
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Salmeterol
Comments mean difference from baseline relative to placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Fluticasone, Placebo
Comments mean difference from baseline relative to placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fluticasone Placebo Salmeterol Fluticasone/Salmeterol
Hide Arm/Group Description

inhalation of 250 mcg of fluticasone

fluticasone: 220- mcg once

inhalation of placebo diskus

placebo inhalation: placebo inhalation once

inhalation of salmeterol 50 mcg once

Salmeterol: 50 mcg salmeterol once

Salmeterol: 50 mcg once

inhalation of fluticasone 250mcg combined with salmeterol 50 mcg

fluticasone/salmeterol: inhalation of 250 mcg of fluticasone combined with 50 mcg of salmeterol

All-Cause Mortality
Fluticasone Placebo Salmeterol Fluticasone/Salmeterol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fluticasone Placebo Salmeterol Fluticasone/Salmeterol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/14 (0.00%)   0/14 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fluticasone Placebo Salmeterol Fluticasone/Salmeterol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/14 (0.00%)   0/14 (0.00%)   0/14 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Adam Wanner, MD
Organization: University of Miami
Phone: (305)243-2568
EMail: awanner@med.miami.edu
Layout table for additonal information
Responsible Party: Adam Wanner, University of Miami
ClinicalTrials.gov Identifier: NCT01231230     History of Changes
Other Study ID Numbers: 20060346
First Submitted: October 25, 2010
First Posted: November 1, 2010
Results First Submitted: March 24, 2014
Results First Posted: December 10, 2014
Last Update Posted: June 30, 2016