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 Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01549340
First received: March 6, 2012
Last updated: July 23, 2014
Last verified: July 2014

March 6, 2012
July 23, 2014
November 2011
May 2012   (final data collection date for primary outcome measure)
  • 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.
  • 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 ]
  • 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 ]
  • 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 that completed the 5-year recommended course of SCIT or SLIT [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01549340 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 ]
Not Provided
Not Provided
 
Retrospective Record Review of Adults and Children Advised for Allergen Immunotherapy (MK-7243-022)
Evaluation of Patient Initiation and Persistence With Advised Allergen Immunotherapy

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.

Not Provided
Observational
Observational Model: Ecologic or Community
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • Perennial Allergic Rhinitis
  • Seasonal Allergic Rhinitis
Not Provided
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.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8790
May 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01549340
7243-022
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP