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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00828061
First received: January 21, 2009
Last updated: May 10, 2010
Last verified: May 2010
Results First Received: April 12, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Diagnostic
Condition: Allergic Rhinitis
Interventions: Drug: Placebo
Drug: prednisone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First Patient Entered: 04-Feb-2009 Last Patient, Last Visit: 21-May-2009 2 sites

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo / Prednisone / Prednisone 1 day placebo, 1 day 10 mg prednisone, 1 day 25 mg prednisone
Prednisone / Prednisone / Placebo 1 day 10 mg prednisone, 1 day 25 mg prednisone, 1 day placebo
Prednisone / Placebo / Prednisone 1 day 25 mg prednisone, 1 day placebo, 1 day 10 mg prednisone
Placebo / Prednisone / Prednisone 1 day placebo, 1 day 25 mg prednisone, 1 day 10 mg prednisone
Prednisone / Placebo / Prednisone 1 day 10 mg prednisone, 1 day placebo, 1 day 25 mg prednisone
Prednisone / Prednisone / Placebo 1 day 25 mg prednisone, 1 day 10 mg prednisone, 1 day placebo

Participant Flow for 3 periods

Period 1:   Period 1
    Placebo / Prednisone / Prednisone     Prednisone / Prednisone / Placebo     Prednisone / Placebo / Prednisone     Placebo / Prednisone / Prednisone     Prednisone / Placebo / Prednisone     Prednisone / Prednisone / Placebo  
STARTED     4     3     3     3     3     3  
COMPLETED     4     3     3     3     3     3  
NOT COMPLETED     0     0     0     0     0     0  

Period 2:   Period 2
    Placebo / Prednisone / Prednisone     Prednisone / Prednisone / Placebo     Prednisone / Placebo / Prednisone     Placebo / Prednisone / Prednisone     Prednisone / Placebo / Prednisone     Prednisone / Prednisone / Placebo  
STARTED     4     3     3     3     3     3  
COMPLETED     4     3     3     3     3     3  
NOT COMPLETED     0     0     0     0     0     0  

Period 3:   Period 3
    Placebo / Prednisone / Prednisone     Prednisone / Prednisone / Placebo     Prednisone / Placebo / Prednisone     Placebo / Prednisone / Prednisone     Prednisone / Placebo / Prednisone     Prednisone / Prednisone / Placebo  
STARTED     4     3     3     3     3     3  
COMPLETED     4     3     3     3     3     3  
NOT COMPLETED     0     0     0     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Patients All patients who completed at least one period and included in the analysis

Baseline Measures
    All Patients  
Number of Participants  
[units: participants]
  19  
Age  
[units: years]
Mean ( Full Range )
  40.4  
  ( 22 to 55 )  
Gender  
[units: participants]
 
Female     2  
Male     17  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Fold Change From Baseline at Hour 8 in Interleukin (IL-5) Concentration   [ Time Frame: Baseline and Hour 8 post nasal allergen challenge ]

2.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Poor cell yields from nasal lavage significantly reduced the utility of eosinophil count data.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372


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