Retrospective Record Review of Adults and Children Advised for Allergen Immunotherapy (MK-7243-022)
This study has been completed.
Information provided by (Responsible Party):
First received: March 6, 2012
Last updated: January 18, 2017
Last verified: January 2017
The purpose of this study is to determine the proportion of participants that initiate allergen immunotherapy (AIT) upon the recommendation of their physician and the proportion of participants that persist with their AIT throughout the recommended course.
Perennial Allergic Rhinitis
Seasonal Allergic Rhinitis
|Study Design:||Observational Model: Ecologic or Community
Time Perspective: Retrospective
|Official Title:||Evaluation of Patient Initiation and Persistence With Advised Allergen Immunotherapy|
Further study details as provided by ALK-Abelló A/S:
Primary Outcome Measures:
- Percentage of Participants Advised to Start AIT Who Elected Subcutaneous Immunotherapy (SCIT) Shots or Sublingual Immunotherapy (SLIT) Drops [ Time Frame: Up to 5 years ]The percentage of participants who were advised by their physician to start AIT and elected to initiate AIT was calculated. AIT initiation was broken down by type of AIT initiated (SCIT or SLIT).
- Percentage of Participants Who Initiated SCIT or SLIT and Completed 5 Years of Treatment [ Time Frame: At 5 years ]The percentage of participants who initiated SCIT or SLIT and completed 5 years of treatment was calculated. Duration of SCIT or SLIT was based on dates when allergy extract prescriptions were refilled. If extract refills continued past the recommended time for therapy (e.g. 5 years from the start of therapy), the participant was deemed successful in completing the recommended course. If the extract refills stopped prior to the end of the recommended time for therapy, but the last refill occurred within 6 months of the recommended time for therapy, this participant was deemed successful in completing the recommended course.
- Duration of Treatment With SCIT or SLIT [ Time Frame: Up to 5 years ]The mean duration in years of SCIT or SLIT treatment for all participants with AR who initiated SCIT or SLIT was calculated. Duration of SCIT or SLIT was based on dates when allergy extract prescriptions were refilled.
- Reason for Discontinuation of SCIT or SLIT More Than 6 Months Before Completion of the Recommended Course [ Time Frame: Up to 5 years ]The reason for discontinuation of SCIT or SLIT treatment more than 6 months before completion of the recommended course of therapy was recorded. The percentage of participants whose records were reveiwed and who discontinued SCIT or SLIT due to different reasons was calculated.
Secondary Outcome Measures:
- Percentage of Participants With a Co-morbidity of Asthma Who Initiated SCIT or SLIT [ Time Frame: Up to 5 years ]The percentage of participants who had AR and asthma and initiated SCIT or SLIT was calculated.
- Duration of SCIT or SLIT Treatment for Participants With AR and Asthma or AR Alone [ Time Frame: Up to 5 years ]The mean duration in years of SCIT or SLIT treatment for all participants with AR and asthma and for all participants with AR only was calculated. Duration of SCIT or SLIT treatment was based on dates when allergy extract prescriptions were refilled.
|Study Start Date:||November 2011|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Participants with Allergic Rhinitis (AR)
Patients in a private allergy practice who were diagnosed with AR, with or without asthma, and advised to consider AIT between January 2005 and June 2011 and whose medical records were retrospectively reviewed.
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