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

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00828061
• Other study ID #: 0000-129
• Secondary ID: 2009_517
• Status: Completed
• Phase: Phase 1
• Start date: February 4, 2009
• Est. completion date: May 21, 2009

Study information

• Verified date: March 2019
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 21, 2009
• Est. primary completion date: May 7, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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 a — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fold Change From Baseline at Hour 8 in Interleukin 5 (IL-5) Concentration	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	Baseline and Hour 8 post nasal allergen challenge
Secondary	Change From Baseline at Hour 8 in the Percent of Total Cells That Are Eosinophils	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	Baseline and Hour 8 post nasal allergen challenge