A Study of the Effects of Single Dose Corticosteroids on Response to Allergens
NCT ID: NCT00828061
Last Updated: 2019-04-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
19 participants
INTERVENTIONAL
2009-02-04
2009-05-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
DOUBLE
Study Groups
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A
placebo
Placebo
Single dose of 5 tablets matching placebo (5 x 0 mg) to prednisone. The washout between treatment periods will be approximately 4 weeks
B
10 mg prednisone
prednisone
Single dose of 5 tablets prednisone totaling 10 mg (3 x 0 mg + 2 x 5 mg). The washout between treatment periods will be approximately 4 weeks.
C
25 mg prednisone
prednisone
Single dose of 5 tablets prednisone totaling 25 mg (5 x 5 mg). The washout between treatment periods will be approximately 4 weeks.
Interventions
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Placebo
Single dose of 5 tablets matching placebo (5 x 0 mg) to prednisone. The washout between treatment periods will be approximately 4 weeks
prednisone
Single dose of 5 tablets prednisone totaling 10 mg (3 x 0 mg + 2 x 5 mg). The washout between treatment periods will be approximately 4 weeks.
prednisone
Single dose of 5 tablets prednisone totaling 25 mg (5 x 5 mg). The washout between treatment periods will be approximately 4 weeks.
Eligibility Criteria
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Inclusion Criteria
* Female patients have a negative pregnancy test and agree to use birth control throughout the study
* Male patients agree to use birth control throughout the study
* Patient has been a nonsmoker for at least 6 months
* Patient agrees to avoid the use of aspirin and other Non-steroidal anti-inflammatory drugs (NSAIDs) throughout study
Exclusion Criteria
* Patient has any respiratory disease other than mild stable asthma that does not require treatment
* Patient consumes more than 3 alcoholic beverages per day
* Patient consumes more than 6 caffeinated beverages per day
* Patient has had major surgery or has donated or lost 1 unit of blood within 4 weeks of screening
* Patient has severe allergies
18 Years
55 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Leaker BR, Malkov VA, Mogg R, Ruddy MK, Nicholson GC, Tan AJ, Tribouley C, Chen G, De Lepeleire I, Calder NA, Chung H, Lavender P, Carayannopoulos LN, Hansel TT. The nasal mucosal late allergic reaction to grass pollen involves type 2 inflammation (IL-5 and IL-13), the inflammasome (IL-1beta), and complement. Mucosal Immunol. 2017 Mar;10(2):408-420. doi: 10.1038/mi.2016.74. Epub 2016 Sep 28.
Other Identifiers
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2009_517
Identifier Type: -
Identifier Source: secondary_id
0000-129
Identifier Type: -
Identifier Source: org_study_id
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