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

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ClinicalTrials.gov Identifier: NCT01549340
Recruitment Status : Completed
First Posted : March 9, 2012
Results First Posted : March 6, 2014
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
ALK-Abelló A/S

Study Description
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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.

Condition or disease
Perennial Allergic Rhinitis Seasonal Allergic Rhinitis

Study Design
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Study Type : Observational
Actual Enrollment : 8790 participants
Observational Model: Ecologic or Community
Time Perspective: Retrospective
Official Title: Evaluation of Patient Initiation and Persistence With Advised Allergen Immunotherapy
Study Start Date : November 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012
Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Advised to Start AIT Who Elected Subcutaneous Immunotherapy (SCIT) Shots or Sublingual Immunotherapy (SLIT) Drops [ Time Frame: 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).

  2. Percentage of Participants Who Initiated SCIT or SLIT and Completed 5 Years of Treatment [ Time Frame: 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.

  3. Duration of Treatment With SCIT or SLIT [ Time Frame: 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.

  4. Reason for Discontinuation of SCIT or SLIT More Than 6 Months Before Completion of the Recommended Course [ Time Frame: 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 :
  1. Percentage of Participants With a Co-morbidity of Asthma Who Initiated SCIT or SLIT [ Time Frame: Up to 5 years ]
    The percentage of participants who had AR and asthma and initiated SCIT or SLIT was calculated.

  2. Duration of SCIT or SLIT Treatment for Participants With AR and Asthma or AR Alone [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Responsible Party: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT01549340     History of Changes
Other Study ID Numbers: 7243-022
First Posted: March 9, 2012    Key Record Dates
Results First Posted: March 6, 2014
Last Update Posted: March 3, 2017
Last Verified: January 2017

Keywords provided by ALK-Abelló A/S:
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