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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00828061
First received: January 21, 2009
Last updated: May 10, 2010
Last verified: May 2010
History of Changes
  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: prednisone
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
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:

MedlinePlus related topics: Steroids
Drug Information available for: Prednisone
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 19
Study Start Date: February 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A
placebo
 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
Active Comparator: B
10 mg prednisone
 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
Active Comparator: C
25 mg 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

  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 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
  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: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00828061     History of Changes
Other Study ID Numbers: 2009_517, 129
Study First Received: January 21, 2009
Results First Received: April 12, 2010
Last Updated: May 10, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Prednisone
Glucocorticoids
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 23, 2013