A Study of the Effects of Single Dose Corticosteroids on Response to Allergens - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00828061

Purpose

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.

Condition	Intervention	Phase
Allergic Rhinitis	Drug: Placebo Drug: Comparator: prednisone	Phase I

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Pharmacodynamics Study
Official Title:	A Randomized Clinical Trial to Study the Effects of Single Dose of Corticosteroid on Response to Nasal Allergen Challenge in Patients

Resource links provided by NLM:

Drug Information available for: Prednisone Corticosteroids

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	18
Study Start Date:	February 2009
Study Completion Date:	June 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Placebo Comparator placebo	Drug: Placebo Single dose of 5 tablets matching placebo to prednisone. The washout between treatment periods will be approximately 4 weeks.
B: Active Comparator 10 mg prednisone	Drug: Comparator: prednisone Single dose of 5 tablets prednisone totaling 10 mg or 25 mg. The washout between treatment periods will be approximately 4 weeks.
C: Active Comparator 25 mg prednisone	Drug: Comparator: prednisone Single dose of 5 tablets prednisone totaling 10 mg or 25 mg. The washout between treatment periods will be approximately 4 weeks.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828061

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2009_517, 129
Study First Received:	January 21, 2009
Last Updated:	August 6, 2009
ClinicalTrials.gov Identifier:	NCT00828061 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Anti-Inflammatory Agents
Prednisone
Otorhinolaryngologic Diseases
Antineoplastic Agents, Hormonal
Respiratory Tract Infections
Respiratory Tract Diseases

Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Rhinitis
Hormones
Glucocorticoids

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Prednisone
Otorhinolaryngologic Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Rhinitis

Glucocorticoids
Hormones
Nose Diseases
Pharmacologic Actions
Respiratory Tract Diseases
Respiratory Tract Infections
Therapeutic Uses

ClinicalTrials.gov processed this record on September 10, 2009