A Study of the Effects of Single Dose Corticosteroids on Response to Allergens

Phase 1

Completed

• Conditions: Allergic Rhinitis
• Interventions: Drug: Placebo; Drug: prednisone

• Registration Number: NCT00828061
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This study will investigate whether changes in inflammatory mediators produced by the nose after exposure to an allergen can be used to evaluate the anti-inflammatory effects of novel drugs for the treatment of allergic asthma.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2009-01-21
• Study First Submitted QC: 2009-01-22
• Study First Posted: 2009-01-23
• Study Start: 2009-02-04
• Primary Completion: 2009-05-07
• Study Completion: 2009-05-21
• Results First Submitted: 2010-04-12
• Results First Submitted QC: 2010-04-12
• Results First Posted: 2010-05-05
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-25
• Last Update Posted: 2019-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Patient is allergic to Timothy grass pollen
• 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

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Exclusion Criteria

• Patient is breastfeeding
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	Placebo	placebo
C	prednisone	25 mg prednisone
B	prednisone	10 mg prednisone

Primary Outcome Measures

Name	Time	Method
Fold Change From Baseline at Hour 8 in Interleukin 5 (IL-5) Concentration	Baseline and Hour 8 post nasal allergen challenge	Comparison of the Change in Allergen-induced Interleukin 5 (IL-5) as Measured in Nasal Exudates After a Single Dose of Low or High Dose of Oral Prednisone Relative to Placebo

Secondary Outcome Measures

Name	Time	Method
Change From Baseline at Hour 8 in the Percent of Total Cells That Are Eosinophils	Baseline and Hour 8 post nasal allergen challenge	Comparison of the Change in the Percent of Total Cells That Are Eosinophils Measured in Nasal Lavage After a Single Dose of 10 mg or 25 mg Prednisone Relative to Placebo