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

Completed

• Conditions: Perennial Allergic Rhinitis; Seasonal Allergic Rhinitis

• Registration Number: NCT01549340
• Lead Sponsor: ALK-Abelló A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-03-06
• Study First Submitted QC: 2012-03-06
• Study First Posted: 2012-03-09
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Results First Submitted: 2014-01-23
• Results First Submitted QC: 2014-01-23
• Results First Posted: 2014-03-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8790

Inclusion Criteria

• Diagnosis of AR with or without allergic conjunctivitis (AC)
• Documented provider-to-patient or parent discussion of AIT as a treatment option

Exclusion Criteria

• Participants receiving AIT as an AR treatment without documented provider-to-patient or parent discussion of AIT as a treatment option
• Participants receiving immunotherapy for insect sensitivities only
• AIT started before 2005

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Advised to Start AIT Who Elected Subcutaneous Immunotherapy (SCIT) Shots or Sublingual Immunotherapy (SLIT) Drops	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	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	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	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

Name	Time	Method
Percentage of Participants With a Co-morbidity of Asthma Who Initiated SCIT or SLIT	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	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.