Retrospective Record Review of Adults and Children Advised for Allergen Immunotherapy (MK-7243-022)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01549340
First received: March 6, 2012
Last updated: July 23, 2014
Last verified: July 2014
Results First Received: January 23, 2014  
Study Type: Observational
Study Design: Observational Model: Ecologic or Community;   Time Perspective: Retrospective
Conditions: Perennial Allergic Rhinitis
Seasonal Allergic Rhinitis

  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
This study involved a retrospective record review of patients in a private allergy and asthma practice who were recommended to receive allergen immunotherapy (AIT) to treat their allergic rhinitis (AR) by their physician between January 2005 and June 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Participants With AR Participants with AR whose records were retrospectively reviewed

Participant Flow:   Overall Study
    Participants With AR  
STARTED     8790 [1]
Started AIT     3182  
COMPLETED     385 [2]
NOT COMPLETED     8405  
[1] Advised to receive AIT
[2] Completed 5 years of AIT



  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.
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Reporting Groups
  Description
Participants With AR Participants with AR whose records were retrospectively reviewed

Baseline Measures
    Participants With AR  
Number of Participants  
[units: participants]
  8790  
Age  
[units: years]
Mean ± Standard Deviation
  26.8  ± 16.1  
Gender  
[units: participants]
 
Female     4439  
Male     4351  



  Outcome Measures
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1.  Primary:   Percentage of Participants Advised to Start AIT Who Elected Subcutaneous Immunotherapy (SCIT) Shots or Sublingual Immunotherapy (SLIT) Drops   [ Time Frame: Up to 5 years ]

2.  Primary:   Percentage of Participants Who Initiated SCIT or SLIT and Completed 5 Years of Treatment   [ Time Frame: At 5 years ]

3.  Primary:   Duration of Treatment With SCIT or SLIT   [ Time Frame: Up to 5 years ]

4.  Primary:   Reason for Discontinuation of SCIT or SLIT More Than 6 Months Before Completion of the Recommended Course   [ Time Frame: Up to 5 years ]

5.  Secondary:   Percentage of Participants With a Co-morbidity of Asthma Who Initiated SCIT or SLIT   [ Time Frame: Up to 5 years ]

6.  Secondary:   Duration of SCIT or SLIT Treatment for Participants With AR and Asthma or AR Alone   [ Time Frame: Up to 5 years ]


  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
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  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: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided by Merck Sharp & Dohme Corp.

Publications automatically indexed to this study:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01549340     History of Changes
Other Study ID Numbers: 7243-022
Study First Received: March 6, 2012
Results First Received: January 23, 2014
Last Updated: July 23, 2014
Health Authority: United States: Food and Drug Administration