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Completed

NCT Number: NCT01549340

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

ALK-Abelló A/S

Industry

Registry information

Official study title

Evaluation of Patient Initiation and Persistence With Advised Allergen Immunotherapy

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 9, 2012
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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