Phase 1 N=19 Randomized Double-blind Diagnostic

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

Allergic Rhinitis

Bottom Line

View on ClinicalTrials.gov: NCT00828061 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2010

Primary outcome: Primary: Fold Change From Baseline at Hour 8 in Interleukin 5 (IL-5) Concentration — 26.94; 6.70; 1.86 Fold Change — p=0.002

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Placebo (Drug); prednisone (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: May 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Fold Change From Baseline at Hour 8 in Interleukin 5 (IL-5) Concentration	26.94; 6.70; 1.86	0.002 sig
SECONDARY Change From Baseline at Hour 8 in the Percent of Total Cells That Are Eosinophils	2.28; 3.17; 6.02	0.537

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00828061). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.