A Randomized Clinical Trial to Study the Effects of Single Dose of Corticosteroid on Response to Nasal Allergen Challenge in Patients

Merck Sharp & Dohme LLC0 sites19 target enrollmentFebruary 4, 2009

ConditionsAllergic Rhinitis

InterventionsPlacebo prednisone

DrugsPlacebo prednisone

Overview

Phase: Phase 1
Intervention: Placebo
Conditions: Allergic Rhinitis
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 19
Primary Endpoint: Fold Change From Baseline at Hour 8 in Interleukin 5 (IL-5) Concentration
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 4, 2009

End Date

May 21, 2009

Last Updated

7 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

Eligibility Criteria

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

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

Arms & Interventions

A

placebo

Intervention: Placebo

B

10 mg prednisone

Intervention: prednisone

C

25 mg prednisone

Intervention: prednisone

Outcomes

Primary Outcomes

Fold Change From Baseline at Hour 8 in Interleukin 5 (IL-5) Concentration

Time Frame: 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