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

NCT01549340 | Completed Results

• 1 other identifier: 7243-022
• Study Type: observational
• Target: 8,790
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Perennial Allergic Rhinitis; Seasonal Allergic Rhinitis

Keywords

Rhinitis; Allergen immunotherapy

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants Advised to Start AIT Who Elected Subcutaneous Immunotherapy (SCIT) Shots or Sublingual Immunotherapy (SLIT) Drops

  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).

  Up to 5 years

• Percentage of Participants Who Initiated SCIT or SLIT and Completed 5 Years of Treatment

  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.

  At 5 years

• Duration of Treatment With SCIT or SLIT

  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.

  Up to 5 years

• Reason for Discontinuation of SCIT or SLIT More Than 6 Months Before Completion of the Recommended Course

  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.

  Up to 5 years

Secondary Outcomes (2)

• Percentage of Participants With a Co-morbidity of Asthma Who Initiated SCIT or SLIT

  Up to 5 years

• Duration of SCIT or SLIT Treatment for Participants With AR and Asthma or AR Alone

  Up to 5 years

Study Arms (1)

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 Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Diagnosis of AR with or without allergic conjunctivitis (AC)
• Documented provider-to-patient or parent discussion of AIT as a treatment option

You may not qualify if:

• 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

Sponsors & Collaborators

• ALK-Abelló A/S: lead

Related Publications (1)

• 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.

  PMID: 24814759 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Rhinitis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: March 9, 2012
• Study Start: November 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: March 3, 2017
• Results First Posted: March 6, 2014

Record last verified: 2017-01