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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Diskus | Placebo Comparator | Placebo comparator |
|
| Salmeterol Diskus 50 mcg twice per day | Experimental | Salmeterol Diskus 50 mcg twice per day |
|
| Placebo diskus, fluticasone | Experimental | placebo diskus, fluticasone MDI 88 mcg twice per day |
|
| Salmeterol, Fluticasone | Experimental | Salmeterol diskus 50 mcg BID, fluticasone MDI 88 mcg twice per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| salmeterol | Drug | salmeterol diskus 50 mcg twice per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Eosinophils are measured 24 hours after the subject has an antigen challenge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Busse, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
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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.
Subjects were recruited at UW Hospital and Clinics, Madison, WI from November 2003 to January 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | All participants completed all 4 arms of the study. 28 days per arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This is a randomized/double-blinded/placebo-controlled/four-phase/crossover trial in subjects with a history of mild allergic asthma. Treatment arms included placebo, fluticasone 44 µg twice daily, salmeterol 50 µµg twice daily and combined FT and SA treatment, all given by inhalers. The order of these treatments was randomized for each subject.
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| ID | Title | Description |
|---|---|---|
| BG000 | 4 Way Cross Over | Participants completed all 4 arms: Placebo, Salmeterol diskus 40 mcg twice per day, Placebo then fluticasone, Salmeterol then Fluticasone, |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants for analysis included any subject that completed that specific treatment phase, even if they did not complete other treatment phases. | Posted | Mean | Standard Deviation | Eosinophil percentage | Eosinophils are measured 24 hours after the subject has an antigen challenge |
|
2.5 years
Subject interview at visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 4 Way Cross Over | Participants completed all 4 treatments: Placebo Salmeterol diskus 50 mcg twice per day Placebo then Fluticasone Salmeterol then Fluticasone |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | ARM: Fluticasone/Placebo |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gina Crisafi | UW Madison | 6082654554 | gmc@medicine.wisc.edu |
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| ID | Term |
|---|---|
| D000068299 | Salmeterol Xinafoate |
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 |
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| Fluticasone | Drug | placebo diskus, fluticasone MDI 88 mcg twice per day |
|
|
| Placebo | Drug | placebo diskus |
|
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants on Placebo/Salmeterol arm |
| OG002 | Placebo/fFuticasone | Participants on Placebo/Fluticasone arm |
| OG003 | Salmeterol/Fluticasone | Participants on Salmeterol/Fluticasone |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 5 |
| 6 |
|
| Increased asthma symptoms | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | ARM: Placebo/Salmeterol |
|
| Back Spasm | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | ARM: Fluticasone/Salmeterol |
|
| Scratchy throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | ARM: Fluticasone/Placebo |
|
| Fainted | Vascular disorders | Non-systematic Assessment | ARM: Fluticasone/Placebo |
|
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| Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |