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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 5 years |
| Duration of SCIT or SLIT Treatment for Participants With AR and Asthma or AR Alone |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24814759 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With AR | Participants with AR whose records were retrospectively reviewed |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With AR | Participants with AR whose records were retrospectively reviewed |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | The analysis population consisted of those participants with AR who were advised by their physician to receive AIT to treat their AR. | Posted | Number | percentage of participants | Up to 5 years |
|
|
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Adverse events leading to discontinuation were reviewed in this retrospective chart review, but clinical and laboratory adverse events were not collected prospectively.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants With AR | Participants with AR whose records were retrospectively reviewed |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| D006255 | Rhinitis, Allergic, Seasonal |
| D012220 | Rhinitis |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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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. |
| Up to 5 years |
| years |
|
| Gender | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | 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. | The analysis population consisted of those participants with AR who were advised by their physician to receive AIT to treat their AR and who initiated AIT. | Posted | Number | percentage of participants | At 5 years |
|
|
|
| Primary | 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. | The analysis population consisted of those participants with AR who were advised by their physician to receive AIT to treat their AR and who initiated AIT. | Posted | Mean | Standard Deviation | years | Up to 5 years |
|
|
|
| Primary | 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. | The analysis population consisted of those participants with AR who were advised by their physician to receive AIT to treat their AR, who initiated and subsequently discontinued AIT, and had their charts reviewed for the reason for discontinuation. | Posted | Number | percentage of participants | Up to 5 years |
|
|
|
| Secondary | 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. | The analysis population consisted of those participants with AR and asthma who were advised by their physician to receive AIT to treat their AR and who initiated SCIT or SLIT. | Posted | Number | percentage of participants | Up to 5 years |
|
|
|
| Secondary | 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. | The analysis population consisted of those participants with AR and asthma or AR alone who were advised by their physician to receive AIT to treat their AR and who initiated AIT. | Posted | Mean | Standard Deviation | years | Up to 5 years |
|
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| 0 |
| 0 |
| 0 |
| 0 |
The Sponsor shall be notified and have a right to timely and prior review of public disclosures of the results, including without limitation, disclosures at research seminars, lectures and professional meetings and submission of papers for publication.
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| Lack of efficacy |
|
| Financial |
|
| Other reason |
|