Allergic Asthma
Conditions
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.
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.
Interventions
DRUGsalmeterol
salmeterol diskus 50 mcg twice per day
DRUGFluticasone
placebo diskus, fluticasone MDI 88 mcg twice per day
DRUGPlacebo
placebo diskus
Sponsors
GlaxoSmithKline
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited at UW Hospital and Clinics, Madison, WI from November 2003 to January 2008.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 4 Way Cross Over Participants completed all 4 arms:
Placebo, Salmeterol diskus 40 mcg twice per day, Placebo then fluticasone, Salmeterol then Fluticasone, | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 11 |
| Overall Study | Screen Failed prior to randomization | 17 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | 4 Way Cross Over |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Age, Continuous | 25.5 years STANDARD_DEVIATION 6.2 |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 5 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Sputum Eosinophils (EOS) 24 Hours Post 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.
Time frame: Eosinophils are measured 24 hours after the subject has an antigen challenge
Population: Participants for analysis included any subject that completed that specific treatment phase, even if they did not complete other treatment phases.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo/Placebo | Sputum Eosinophils (EOS) 24 Hours Post Antigen Challenge | 3.5 Eosinophil percentage | Standard Deviation 3.4 |
| Placebo/Salmeterol | Sputum Eosinophils (EOS) 24 Hours Post Antigen Challenge | 2.4 Eosinophil percentage | Standard Deviation 3.4 |
| Placebo/fFuticasone | Sputum Eosinophils (EOS) 24 Hours Post Antigen Challenge | 0.54 Eosinophil percentage | Standard Deviation 0.39 |
| Salmeterol/Fluticasone | Sputum Eosinophils (EOS) 24 Hours Post Antigen Challenge | 2.4 Eosinophil percentage | Standard Deviation 2.6 |