An observational study in Perennial Allergic Rhinitis and Seasonal Allergic Rhinitis, sponsored by ALK-Abelló A/S. Completed. Per ClinicalTrials.gov, last updated 2017-03-03.
Sponsored by ALK-Abelló A/S · Observational
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.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 8,790 is above the median of 141 across 172 observational studies indexed under Rhinitis.
Browse Rhinitis studies →ALK-Abelló A/S is the lead sponsor of 66 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 5 years
Percentage of Participants With a Co-morbidity of Asthma Who Initiated SCIT or SLIT
The percentage of participants who had AR and asthma and initiated SCIT or SLIT was calculated.
Time frame: Up to 5 years
Duration of SCIT or SLIT Treatment for Participants With AR and Asthma or AR Alone
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.
Time frame: Up to 5 years
This study involved a retrospective record review of patients in a private allergy and asthma practice who were recommended to receive allergen immunotherapy (AIT) to treat their allergic rhinitis (AR) by their physician between January 2005 and June 2011.
| Milestone | Participants With AR |
|---|---|
| Started | 8790 |
| Started ait | 3182 |
| Completed | 385 |
| Not completed | 8405 |
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 | Participants With AR |
|---|---|
| Elected SCIT | 28.2 |
| Elected SLIT | 8.0 |
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.
| percentage of participants | Participants With AR |
|---|---|
| Completed 5 years of SCIT (n=2481) | 10.8 |
| Completed 5 years of SLIT (n=701) | 2.6 |
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.
| years | Participants With AR |
|---|---|
| SCIT | 2.4 ± 1.8 |
| SLIT | 1.9 ± 1.4 |
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.
| percentage of participants | Participants With AR Who Discontinued SCIT | Participants With AR Who Discontinued SLIT |
|---|---|---|
| No reason documented | 67 | 69 |
| Adverse event | 7 | 4 |
| Lack of efficacy | 1 | 3 |
| Financial | 4 | 4 |
| Other reason | 21 | 20 |
The percentage of participants who had AR and asthma and initiated SCIT or SLIT was calculated.
| percentage of participants | Participants With AR and Asthma |
|---|---|
| Initiated SCIT | 25.2 |
| Initiated SLIT | 8.7 |
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.
| years | Participants With AR and Asthma | Participants With AR Alone |
|---|---|---|
| SCIT | 2.4 ± 1.77 | 2.4 ± 1.82 |
| SLIT | 2.1 ± 1.50 | 1.8 ± 1.37 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Participants With AR | — | — | — |
| Age, Continuous(years) | Participants With AR |
|---|---|
| Mean | 26.8 ± 16.1 |
| Gender(Participants) | Participants With AR |
|---|---|
| Female | 4439 |
| Male | 4351 |
No study locations are listed for this record.
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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ALK-Abelló A/S