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

ClinicalTrials.gov Identifier:

NCT01549340

First received: March 6, 2012

Last updated: June 21, 2012

Last verified: June 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 6, 2012
Last Updated Date	June 21, 2012
Start Date ^ICMJE	November 2011
Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 6, 2012)	Proportion of participants with allergic rhinitis advised to consider allergen immunotherapy (AIT) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ] Proportion of participants advised to start AIT that elected subcutaneous immunotherapy (SCIT) or sublingual immunotherapy (SLIT) drops [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ] Proportion of participants that completed the 5-year recommended course of SCIT or SLIT [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ] Duration of treatment with SCIT or SLIT [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ] Basis for discontinuation of AIT more than 6 months before completion of the recommended course [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01549340 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 6, 2012)	Proportion of participants with a co-morbidity of asthma that elected SCIT or SLIT [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ] Duration of AIT for participants with allergic rhinitis (AR) and asthma or AR alone. [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Retrospective Record Review of Adults and Children Advised for Allergen Immunotherapy (MK-7243-022)
Official Title ^ICMJE	Evaluation of Patient Initiation and Persistence With Advised Allergen Immunotherapy
Brief Summary	The purpose of this study is to determine the proportion of participants that initiate allergen immunotherapy upon the recommendation of their physician and the proportion of participants that persist with their allergen immunotherapy throughout the recommended course.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Ecologic or Community Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Patients in a database recommended for allergen immunotherapy by their physicians between 2005 and 2011 in the United States.
Condition ^ICMJE	Perennial Allergic Rhinitis Seasonal Allergic Rhinitis
Intervention ^ICMJE	Biological: Allergen Immunotherapy Participants receiving subcutaneous immunotherapy or sublingual immunotherapy drops as per routine clinical practice.
Study Group/Cohort (s)	Participants with Allergic Rhinitis and Asthma Intervention: Biological: Allergen Immunotherapy Participants with Allergic Rhinitis Alone Intervention: Biological: Allergen Immunotherapy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	8790
Completion Date	May 2012
Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Diagnosis of allergic rhinitis with or without allergic conjunctivitis Documented provider-to-patient or parent discussion of allergen immunotherapy as a treatment option Exclusion Criteria: Participants receiving allergen immunotherapy as an allergic rhinitis treatment without documented provider-to-patient or parent discussion of allergen immunotherapy as a treatment option Participants receiving immunotherapy for insect sensitivities only Allergen immunotherapy started before 2005
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01549340
Other Study ID Numbers ^ICMJE	MK-7243-022
Has Data Monitoring Committee	No
Responsible Party	Merck
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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