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

Purpose

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.

Condition
Perennial Allergic Rhinitis Seasonal Allergic Rhinitis


Study Type:	Observational
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 Merck Sharp & Dohme Corp.:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
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.


Enrollment:	8790
Study Start Date:	November 2011
Study Completion Date:	May 2012
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts
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.

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients who were managed by physicians in a large allergy practice, recommended for AIT between 2005 and 2011 and identified by their electronic health records.

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Anolik R, Schwartz AM, Sajjan S, Allen-Ramey F. Patient initiation and persistence with allergen immunotherapy. Ann Allergy Asthma Immunol. 2014 Jul;113(1):101-7. doi: 10.1016/j.anai.2014.04.008. Epub 2014 May 9.


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:	June 8, 2015
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:


Rhinitis Allergen immunotherapy

Additional relevant MeSH terms:


Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal Rhinitis, Allergic, Perennial Nose Diseases Respiratory Tract Diseases	Respiratory Tract Infections Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases

ClinicalTrials.gov processed this record on September 23, 2016