Back to resultsA Study of the Effects of Single Dose Corticosteroids on Response to Allergens
Primary Purpose
Allergic Rhinitis
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Placebo
prednisone
prednisone
Sponsored by
About this trial
This is an interventional diagnostic trial for Allergic Rhinitis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
A
B
C
Arm Description
placebo
10 mg prednisone
25 mg prednisone
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00828061
First Posted
January 21, 2009
Last Updated
March 25, 2019
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00828061
Brief Title
A Study of the Effects of Single Dose Corticosteroids on Response to Allergens
Official Title
A Randomized Clinical Trial to Study the Effects of Single Dose of Corticosteroid on Response to Nasal Allergen Challenge in Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
February 4, 2009 (Actual)
Primary Completion Date
May 7, 2009 (Actual)
Study Completion Date
May 21, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Placebo Comparator
Arm Description
placebo
Arm Title
B
Arm Type
Active Comparator
Arm Description
10 mg prednisone
Arm Title
C
Arm Type
Active Comparator
Arm Description
25 mg prednisone
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single dose of 5 tablets matching placebo (5 x 0 mg) to prednisone. The washout between treatment periods will be approximately 4 weeks
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Description
Single dose of 5 tablets prednisone totaling 25 mg (5 x 5 mg). The washout between treatment periods will be approximately 4 weeks.
Primary Outcome Measure Information:
Title
Fold Change From Baseline at Hour 8 in Interleukin 5 (IL-5) Concentration
Description
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
Time Frame
Baseline and Hour 8 post nasal allergen challenge
Secondary Outcome Measure Information:
Title
Change From Baseline at Hour 8 in the Percent of Total Cells That Are Eosinophils
Description
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
Time Frame
Baseline and Hour 8 post nasal allergen challenge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
27677865
Citation
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.
Results Reference
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A Study of the Effects of Single Dose Corticosteroids on Response to Allergens
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