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

Seasonal Allergic Rhinitis Clinical Trial

Official title:

Evaluation of Patient Initiation and Persistence With Advised Allergen Immunotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01549340
• Other study ID #: 7243-022
• Status: Completed
• Phase: N/A
• First received: March 6, 2012
• Last updated: June 8, 2015
• Start date: November 2011
• Est. completion date: May 2012

Study information

• Verified date: June 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8790
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Ecologic or Community, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Perennial Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic, Perennial
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Advised to Start AIT Who Elected Subcutaneous Immunotherapy (SCIT) Shots or Sublingual Immunotherapy (SLIT) Drops	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).	Up to 5 years	No
Primary	Percentage of Participants Who Initiated SCIT or SLIT and Completed 5 Years of Treatment	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.	At 5 years	No
Primary	Duration of Treatment With SCIT or SLIT	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.	Up to 5 years	No
Primary	Reason for Discontinuation of SCIT or SLIT More Than 6 Months Before Completion of the Recommended Course	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.	Up to 5 years	No
Secondary	Percentage of Participants With a Co-morbidity of Asthma Who Initiated SCIT or SLIT	The percentage of participants who had AR and asthma and initiated SCIT or SLIT was calculated.	Up to 5 years	Yes
Secondary	Duration of SCIT or SLIT Treatment for Participants With AR and Asthma or AR Alone	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.	Up to 5 years	No