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

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.

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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Single dose of 5 tablets matching placebo (5 x 0 mg) to prednisone. The washout between treatment periods will be approximately 4 weeks

Prednisone

Drug

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.

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

Secondary outcomes

Change From Baseline at Hour 8 in the Percent of Total Cells That Are Eosinophils

Time frame: 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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Jan 23, 2009
Registry last updated: Apr 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed