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

NCT00828061 | Completed Phase 1 Results

• 2 other identifiers: 0000-1292009_517
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Baseline and Hour 8 post nasal allergen challenge

Study Arms (3)

A

PLACEBO COMPARATOR

placebo

Drug: Placebo

B

ACTIVE COMPARATOR

10 mg prednisone

Drug: prednisone

C

ACTIVE COMPARATOR

25 mg prednisone

Drug: prednisone

Interventions

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

A

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.

B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related 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 and IL-13), the inflammasome (IL-1beta), and complement. Mucosal Immunol. 2017 Mar;10(2):408-420. doi: 10.1038/mi.2016.74. Epub 2016 Sep 28.

  PMID: 27677865 RESULT

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Prednisone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

Poor cell yields from nasal lavage significantly reduced the utility of eosinophil count data.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2009
• First Posted: January 23, 2009
• Study Start: February 4, 2009
• Primary Completion: May 7, 2009
• Study Completion: May 21, 2009
• Last Updated: April 2, 2019
• Results First Posted: May 5, 2010

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share