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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Allergic Rhinitis

Treatments: Drug: prednisone; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00828061

0000-129

2009_517

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

19 participants in 3 patient groups, including a placebo group

A

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Placebo

B

Active Comparator group

Description:

10 mg prednisone

Treatment:

Drug: prednisone

Drug: prednisone

C

Active Comparator group

Description:

25 mg prednisone

Treatment:

Drug: prednisone

Drug: prednisone