Allergic RhinitisNCT05881577
The Effect of Allergic Rhinitis on Educational Outcomes
An observational study of Allergic Rhinitis, run by ALK-Abelló A/S at 1 site in Denmark.
Trial summary
The study will assess the the burden of living with allergic rhinitis (AR) and the effect of AR on school performance for children and adolescents in Denmark. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Observational
- How many people
- 150,000 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Feb 2023to 31 Jul 2023
- How long will I take part?
- 25 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- Child
Study population: children who have been diagnosed with AR before turning 13
Who may be able to join
- The main study population (cases) consists of children who have been diagnosed with AR before turning 13. Diagnosis of AR will be identified by dispensations of prescribed AR medications, ICD-10 codes of AR-related hospitalisations and reimbursement codes for AR-related healthcare contacts in the primary healthcare sector.
- At least two dispensed prescriptions of product containing intranasal corticosteroids (INCS) or antihistamines during the same calendar year for two consecutive years OR at least one visit with the primary healthcare sector with registered AR consultations AND at least one dispensed prescriptions of product containing INCS or antihistamines OR at least one contact with the hospital sector with an ICD-10 code for AR (primary or secondary diagnosis).
Who cannot join
- Children with their first AR-related healthcare contact or first AR-specific dispensed prescription at the age of 13 or older will be excluded.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
ALK Abello
Hørsholm, Capital Region, 2970
Mercedes Romano, PharmD MBA, +4522971265, MRRDK@ALK.NET
About this study
Official title: The Effect of Allergic Rhinitis on Educational Outcomes - a Register-based Study
The study will assess the the burden of living with allergic rhinitis (AR) and the effect of AR on school performance for children and adolescents in Denmark.
Read the detailed description
The aim of the study is to investigate the effect of AR on school performance and examination test grades for children and adolescents diagnosed with AR early in life, as well as analyse their burden of disease and healthcare resource use using real-world data from the exhaustive Danish population registers. This is a retrospective registry analysis that uses Danish registers during 1994 and 2021.
In Denmark, national registers collect data for the entire Danish population from birth to death and have done so for decades. This exhaustive data creates a sound foundation for this study of the impact of school performance caused by AR, as subjects can be traced with high certainty and detail over several years.
- Conditions
- Allergic Rhinitis
- Being tested
- Observational
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Impact of AR on educational outcomes
| Study group | Role | What they receive |
|---|---|---|
| Cases | The primary study population will consist of subjects with AR Receives: Other: Observational | |
| Matched controls | children with no history of AR | |
| Sibling controls | siblings of the subjects in the case group with no history of AR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary school final examination test grades (oral and written) in: Language (Danish, English), Mathematics Obtained high school degree Obtained university degree
Test grades
Measured: 1994-2021
Secondary outcomes (3)
Cost of inpatient and outpatient hospitalisation
Cost in DKK
Measured: 1994-2021
Cost of prescription medicine
Cost in DKK
Measured: 1994-2021
Number of inpatient and outpatient visits
The number of inpatient/outpatients visits per year.
Measured: 1994-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start15 Feb 2023
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 150,000 participants (estimated)
- Target duration
- 25 Years
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ernst & Young
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881577
- Sponsor's protocol ID
- NI-X-06
- Status last verified
- May 2023
- First submitted
- 16 Feb 2023
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Allergic Rhinitis on Educational Outcomes - a Register-based Study
- ClinicalTrials.gov ID
- NCT05881577
- Acronym / sponsor ID
- NI-X-06
- Conditions
- Allergic Rhinitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150,000 participants (estimated)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Collaborators
- Ernst & Young
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will assess the the burden of living with allergic rhinitis (AR) and the effect of AR on school performance for children and adolescents in Denmark.
Detailed description
The aim of the study is to investigate the effect of AR on school performance and examination test grades for children and adolescents diagnosed with AR early in life, as well as analyse their burden of disease and healthcare resource use using real-world data from the exhaustive Danish population registers. This is a retrospective registry analysis that uses Danish registers during 1994 and 2021.
In Denmark, national registers collect data for the entire Danish population from birth to death and have done so for decades. This exhaustive data creates a sound foundation for this study of the impact of school performance caused by AR, as subjects can be traced with high certainty and detail over several years.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 25 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: ObservationalThe primary study population will consist of subjects with AR |
| Matched controls | – | –children with no history of AR |
| Sibling controls | – | –siblings of the subjects in the case group with no history of AR |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- children who have been diagnosed with AR before turning 13
Key inclusion criteria (2 listed)
- The main study population (cases) consists of children who have been diagnosed with AR before turning 13. Diagnosis of AR will be identified by dispensations of prescribed AR medications, ICD-10 codes of AR-related hospitalisations and reimbursement codes for AR-related healthcare contacts in the primary healthcare sector.
- At least two dispensed prescriptions of product containing intranasal corticosteroids (INCS) or antihistamines during the same calendar year for two consecutive years OR at least one visit with the primary healthcare sector with registered AR consultations AND at least one dispensed prescriptions of product containing INCS or antihistamines OR at least one contact with the hospital sector with an ICD-10 code for AR (primary or secondary diagnosis).
Key exclusion criteria (1 listed)
- Children with their first AR-related healthcare contact or first AR-specific dispensed prescription at the age of 13 or older will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalImpact of AR on educational outcomes | Other | Cases |
Primary outcome
Primary school final examination test grades (oral and written) in: Language (Danish, English), Mathematics Obtained high school degree Obtained university degree
Time frame: 1994-2021
Test grades
3 secondary outcomes
Cost of inpatient and outpatient hospitalisation
Time frame: 1994-2021
Cost of prescription medicine
Time frame: 1994-2021
Number of inpatient and outpatient visits
Time frame: 1994-2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Allergic Rhinitis
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RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
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Enrolling by invitationObservational study
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Not yet recruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinitis, run by ALK-Abelló A/S at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mercedes Romano, Pharm D, MBA (+4522971265, MRRDK@ALK.NET), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary school final examination test grades (oral and written) in: Language (Danish, English), Mathematics Obtained high school degree Obtained university degree (time frame: 1994-2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.