Allergic Rhinitis
Conditions
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.
Interventions
DRUGPlacebo
Single dose of 5 tablets matching placebo (5 x 0 mg) to prednisone. The washout between treatment periods will be approximately 4 weeks
DRUGprednisone
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.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fold Change From Baseline at Hour 8 in Interleukin 5 (IL-5) Concentration | Baseline and Hour 8 post nasal allergen challenge | 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline at Hour 8 in the Percent of Total Cells That Are Eosinophils | Baseline and Hour 8 post nasal allergen challenge | 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 |
Participant flow
Recruitment details
First Patient Entered: 04-Feb-2009 Last Patient, Last Visit: 21-May-2009 2 sites
Participants by arm
| Arm | Count |
|---|---|
| All Patients All patients who completed at least one period are included in the analysis | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | All Patients |
|---|---|
| Age, Continuous | 40.4 years |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 12 / 19 | 8 / 19 | 8 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 | 0 / 19 |
Outcome results
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
Time frame: Baseline and Hour 8 post nasal allergen challenge
Population: All Patients as Treated
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Placebo | Fold Change From Baseline at Hour 8 in Interleukin 5 (IL-5) Concentration | 26.94 Fold Change |
| 10 mg Prednisone | Fold Change From Baseline at Hour 8 in Interleukin 5 (IL-5) Concentration | 6.70 Fold Change |
| 25 mg Prednisone | Fold Change From Baseline at Hour 8 in Interleukin 5 (IL-5) Concentration | 1.86 Fold Change |
p-value: 0.00295% CI: [0.12, 0.54]ANOVA
p-value: <0.00195% CI: [0.03, 0.15]ANOVA
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
Time frame: Baseline and Hour 8 post nasal allergen challenge
Population: All Patients with Slide Quality ≤ 3 (Slide Quality measured on a 6 point scale with values \> 3 indicating a level of debris that interferes with cell typing and counting).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline at Hour 8 in the Percent of Total Cells That Are Eosinophils | 2.28 Percentage of cells that are eosinophils |
| 10 mg Prednisone | Change From Baseline at Hour 8 in the Percent of Total Cells That Are Eosinophils | 3.17 Percentage of cells that are eosinophils |
| 25 mg Prednisone | Change From Baseline at Hour 8 in the Percent of Total Cells That Are Eosinophils | 6.02 Percentage of cells that are eosinophils |
p-value: 0.53795% CI: [-15.48, 17.26]ANOVA