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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00828061
First received: January 21, 2009
Last updated: May 10, 2010
Last verified: May 2010

January 21, 2009
May 10, 2010
February 2009
May 2009   (final data collection date for primary outcome measure)
Fold Change From Baseline at Hour 8 in Interleukin (IL-5) Concentration [ Time Frame: Baseline and Hour 8 post nasal allergen challenge ] [ Designated as safety issue: No ]
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
Change in allergen-induced inflammatory markers as measured in nasal exudates after a single dose of oral prednisone [ Time Frame: Pre and post nasal allergen challenge ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00828061 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Comparison of the Change in the Percent of Total Cells That Are Eosinophils Measured in Nasal Lavage After a Single Dose of 10 mg Prednisone Relative to Placebo
Comparison of dose response effects of single dose prednisone and placebo on fluid phase markers of inflammation [ Time Frame: Pre and post nasal allergen challenge ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of the Effects of Single Dose Corticosteroids on Response to Allergens
A Randomized Clinical Trial to Study the Effects of Single Dose of Corticosteroid on Response to Nasal Allergen Challenge in Patients

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Allergic Rhinitis
  • 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
  • Drug: 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.
    Other Name: prednisone
  • Drug: prednisone
    Single dose of 5 tablets prednisone totaling 25 mg (5 x 5 mg). The washout between treatment periods will be approximately 4 weeks.
    Other Name: prednisone
  • Placebo Comparator: A
    placebo
    Intervention: Drug: Placebo
  • Active Comparator: B
    10 mg prednisone
    Intervention: Drug: prednisone
  • Active Comparator: C
    25 mg prednisone
    Intervention: Drug: prednisone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
May 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00828061
2009_517, 129
No
Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP