The Effect of Salmeterol on Eosinophil (EOS) Function

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Completed
• CT.gov ID: NCT00214019
• Collaborator: GlaxoSmithKline (Industry)
• Enrollment: 36
• Location: 1
• Arms: 4
• Actual Duration (Months): 50
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

This study is designed to test the hypothesis that salmeterol use, and not fluticasone use or the combination treatment with fluticasone and salmeterol, is associated with a greater number of sputum eosinophils following antigen challenge and, under these circumstances, the migrating peripheral blood eosinophils are less adherent.

Condition or Disease	Intervention/Treatment	Phase
Allergic Asthma	Drug: salmeterol; Drug: Fluticasone; Drug: Placebo	N/A

Detailed Description

An antigen challenge is when a participant inhales either cat, ragweed, or dust dander in increasing concentrations until their lung function drops 15 or 20 percent.

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: The Effect of Salmeterol on Eosinophil (EOS) Function
• Actual Study Start Date: Nov 1, 2003
• Actual Primary Completion Date: Jan 1, 2008
• Actual Study Completion Date: Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Diskus Placebo comparator	Drug: Placebo; placebo diskus; Other Names: no drug comparator treatment
Experimental: Salmeterol Diskus 50 mcg twice per day Salmeterol Diskus 50 mcg twice per day	Drug: salmeterol; salmeterol diskus 50 mcg twice per day; Other Names: Seravent Advair
Experimental: Placebo diskus, fluticasone placebo diskus, fluticasone MDI 88 mcg twice per day	Drug: Fluticasone; placebo diskus, fluticasone MDI 88 mcg twice per day; Other Names: flovent advair
Experimental: Salmeterol, Fluticasone Salmeterol diskus 50 mcg BID, fluticasone MDI 88 mcg twice per day	Drug: salmeterol; salmeterol diskus 50 mcg twice per day; Other Names: Seravent Advair ; Drug: Fluticasone; placebo diskus, fluticasone MDI 88 mcg twice per day; Other Names: flovent advair

Outcome Measures

Primary Outcome Measures

1. Sputum Eosinophils (EOS) 24 Hours Post Antigen Challenge [Eosinophils are measured 24 hours after the subject has an antigen challenge]

   Sputum samples were collected from the participants. Cell counts were made from these samples after treatment with 0.1% dithiothreitol. Percentage of eosinophils were reported. Time frame measurement was 24 hours after the subject had an antigen challenge.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18-55 years of age

• history of asthma symptoms for the previous 6 months

• Forced Expiratory Value (FEV1) >75% of predicted

• positive prick skin test to cat, house dust mite or ragweed

Exclusion Criteria:

• history of life threatening asthma or anaphylaxis

• current smoker

• pregnant or breast-feeding

• evidence of an upper respiratory infection within 4 weeks of screening

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Wisconsin	Madison	Wisconsin	United States	53792

Sponsors and Collaborators

• University of Wisconsin, Madison
• GlaxoSmithKline

Investigators

• Principal Investigator: William Busse, MD, University of Wisconsin, Madison

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT00214019
• Other Study ID Numbers: H-2003-0469
• First Posted: Sep 21, 2005
• Last Update Posted: Nov 21, 2017
• Last Verified: Oct 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Fluticasone; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination

Study Results

Participant Flow

Recruitment Details	Subjects were recruited at UW Hospital and Clinics, Madison, WI from November 2003 to January 2008.
Pre-assignment Detail	6 participants completed all four arms of the study. 36 participants were recruited; 17 screen failed prior to randomization, 11 were lost to follow up prior to randomization, and 2 withdrew consent prior to randomization.

Arm/Group Title	All Study Participants
Arm/Group Description	All participants completed all 4 arms of the study. 28 days per arm.
Period Title: Overall Study
STARTED	36
Placebo/Placebo Arm	6
Placebo/Salmeterol Arm	6
Fluticasone/Placebo Arm	6
Fluticason/Salmeterol Arm	6
COMPLETED	6
NOT COMPLETED	30

Baseline Characteristics

Arm/Group Title	4 Way Cross Over
Arm/Group Description	Participants completed all 4 arms: Placebo, Salmeterol diskus 40 mcg twice per day, Placebo then fluticasone, Salmeterol then Fluticasone,
Overall Participants	6
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	6 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	25.5 (6.2)
Sex: Female, Male (Count of Participants)
Female	3 50%
Male	3 50%
Region of Enrollment (participants) [Number]
United States	6 100%

Outcome Measures

1. Primary Outcome

Title	Sputum Eosinophils (EOS) 24 Hours Post Antigen Challenge
Description	Sputum samples were collected from the participants. Cell counts were made from these samples after treatment with 0.1% dithiothreitol. Percentage of eosinophils were reported. Time frame measurement was 24 hours after the subject had an antigen challenge.
Time Frame	Eosinophils are measured 24 hours after the subject has an antigen challenge

Outcome Measure Data

Analysis Population Description

Participants for analysis included any subject that completed that specific treatment phase, even if they did not complete other treatment phases.

Arm/Group Title	Placebo/Placebo	Placebo/Salmeterol	Placebo/fFuticasone	Salmeterol/Fluticasone
Arm/Group Description	Participants on Placebo/Placebo arm	Participants on Placebo/Salmeterol arm	Participants on Placebo/Fluticasone arm	Participants on Salmeterol/Fluticasone
Measure Participants	6	6	6	6
Mean (Standard Deviation) [Eosinophil percentage]	3.5 (3.4)	2.4 (3.4)	0.54 (0.39)	2.4 (2.6)

Adverse Events

Time Frame	2.5 years
Adverse Event Reporting Description	Subject interview at visit
Arm/Group Title	4 Way Cross Over
Arm/Group Description	Participants completed all 4 treatments: Placebo Salmeterol diskus 50 mcg twice per day Placebo then Fluticasone Salmeterol then Fluticasone
All Cause Mortality
	4 Way Cross Over
	Affected / at Risk (%)	# Events
Total	0/6 (0%)
Serious Adverse Events
	4 Way Cross Over
	Affected / at Risk (%)	# Events
Total	0/6 (0%)
Other (Not Including Serious) Adverse Events
	4 Way Cross Over
	Affected / at Risk (%)	# Events
Total	5/6 (83.3%)
Musculoskeletal and connective tissue disorders
Back Spasm	1/6 (16.7%)	1
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection	1/6 (16.7%)	1
Increased asthma symptoms	1/6 (16.7%)	1
Scratchy throat	1/6 (16.7%)	1
Vascular disorders
Fainted	1/6 (16.7%)	1

Limitations/Caveats

36 subjects were screened, identifying subjects with both a peripheral eosinophil count >0.200x106 cells/ml and a LPR >15% was more difficult than expected. Of the subjects screened, only 12 met criteria and 6 subjects completed.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.