AllergyNCT04125888
Impact of AIT on Allergic Rhinitis and Asthma
An observational study of Allergy and Respiratory Disease, run by ALK-Abelló A/S at 1 site in Denmark.
Trial summary
The study will assess the effectiveness of AIT treatment in real clinical practice in Germany. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Allergy, Respiratory Disease
- What is being tested?
- Allergy immunotherapy (AIT)
- How many people
- 92,048 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Jul 2019to 16 Apr 2021
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Allergic rhinitis patients with and without asthma
Who may be able to join
- At least two index-AIT prescriptions during the first FU-year
- At least one confirmed AR diagnosis during the study period
- Continuous enrollment (no gaps in insurance time-defined by days) for 12 months before the index event (in the pre-index period)
- Continuous enrollment (no gaps in insurance time-defined by days) for at least 12 months after the index event (in the post-index period)
- For the control groups, the same inclusion criteria will apply, with the exception of inclusion criterion 1, i.e. controls have not received AIT before baseline.
Who cannot join
- AIT prescription 12 months before the index event (in the pre-index period) for the AIT treatment group
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of AIT on Allergic Rhinitis and Asthma Using Real World Evidence
The study will assess the effectiveness of AIT treatment in real clinical practice in Germany.
Read the detailed description
Allergic rhinitis (AR) affects 23-30% of the European population and is associated with a major burden on public health. AR and asthma frequently coexist, and may both be caused by allergen exposure. While the efficacy of AIT, i.e. reduce symptoms and medication use in patients with AR and asthma, has been demonstrated in several randomized clinical trials, little is known about the use and effectiveness of AIT in real world clinical practice.
This study is a retrospective database study that uses real-world data from Germany. The study population consists of AR patients with and without asthma treated with AIT and matched controls not treated with AIT. Information about the patients and treatments will be obtained from the 'BKK German Sickness Fund Database' from 2007 until 2017.
- Conditions
- Allergy, Respiratory Disease
- Being tested
- Allergy immunotherapy (AIT)
- Medical subject headings
- Hypersensitivity, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allergy immunotherapy (AIT)Drug
Immunotherapy for different types of allergies
| Study group | Role | What they receive |
|---|---|---|
| AIT Cohort | Allergic rhinitis patients with and without asthma treated with AIT Receives: Drug: Allergy immunotherapy (AIT) | |
| Control Cohort | Allergic rhinitis patients with and without asthma not treated with AIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allergic rhinitis medication use
Number of patients with an AR prescription and number of prescriptions by drug class
Measured: From pre-index year to follow-up year(s), assessed from 2007 and up to 2017
Secondary outcomes (2)
Asthma medication use
Number of patients with an asthma prescription and number of prescriptions by drug class
Measured: From pre-index to follow-up year(s), assessed from 2007 and up to 2017
Change in asthma disease severity
Change in asthma disease severity assessed by asthma diagnoses, asthma medication use and severe asthma exacerbation
Measured: From pre-index to follow-up year(s), assessed from 2007 and up to 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start22 Jul 2019
- Primary completion16 Apr 2021
- Study completion16 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AllergyStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 92,048 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mercedes Romano, PharmD, MBA, MSc, Study director, ALK Abelló
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125888
- Sponsor's protocol ID
- NI-X-04
- Status last verified
- May 2021
- First submitted
- 4 Oct 2019
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fritzsching B, Contoli M, Porsbjerg C, Buchs S, Larsen JR, Elliott L, Rodriguez MR, Freemantle N. Long-term real-world effectiveness of allergy immunotherapy in patients with allergic rhinitis and asthma: Results from the REACT study, a retrospective cohort study. Lancet Reg Health Eur. 2021 Nov 30;13:100275. doi: 10.1016/j.lanepe.2021.100275. eCollection 2022 Feb.
PubMed 34901915
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of AIT on Allergic Rhinitis and Asthma Using Real World Evidence
- ClinicalTrials.gov ID
- NCT04125888
- Acronym / sponsor ID
- NI-X-04
- Conditions
- Allergy, Respiratory Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92,048 participants (actual)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 16 Apr 2021 (actual)
- Study completion
- 16 Apr 2021 (actual)
- First posted
- 14 Oct 2019 (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 effectiveness of AIT treatment in real clinical practice in Germany.
Detailed description
Allergic rhinitis (AR) affects 23-30% of the European population and is associated with a major burden on public health. AR and asthma frequently coexist, and may both be caused by allergen exposure. While the efficacy of AIT, i.e. reduce symptoms and medication use in patients with AR and asthma, has been demonstrated in several randomized clinical trials, little is known about the use and effectiveness of AIT in real world clinical practice.
This study is a retrospective database study that uses real-world data from Germany. The study population consists of AR patients with and without asthma treated with AIT and matched controls not treated with AIT. Information about the patients and treatments will be obtained from the 'BKK German Sickness Fund Database' from 2007 until 2017.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIT Cohort | – | Drug: Allergy immunotherapy (AIT)Allergic rhinitis patients with and without asthma treated with AIT |
| Control Cohort | – | –Allergic rhinitis patients with and without asthma not treated with AIT |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Allergic rhinitis patients with and without asthma
Key inclusion criteria (5 listed)
- At least two index-AIT prescriptions during the first FU-year
- At least one confirmed AR diagnosis during the study period
- Continuous enrollment (no gaps in insurance time-defined by days) for 12 months before the index event (in the pre-index period)
- Continuous enrollment (no gaps in insurance time-defined by days) for at least 12 months after the index event (in the post-index period)
- For the control groups, the same inclusion criteria will apply, with the exception of inclusion criterion 1, i.e. controls have not received AIT before baseline.
Key exclusion criteria (1 listed)
- AIT prescription 12 months before the index event (in the pre-index period) for the AIT treatment group
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 |
|---|---|---|
| Allergy immunotherapy (AIT)Immunotherapy for different types of allergies | Drug | AIT Cohort |
Primary outcome
Allergic rhinitis medication use
Time frame: From pre-index year to follow-up year(s), assessed from 2007 and up to 2017
Number of patients with an AR prescription and number of prescriptions by drug class
2 secondary outcomes
Asthma medication use
Time frame: From pre-index to follow-up year(s), assessed from 2007 and up to 2017
Change in asthma disease severity
Time frame: From pre-index to follow-up year(s), assessed from 2007 and up to 2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Derived from this study: PubMed 34901915Fritzsching B, Contoli M, Porsbjerg C, Buchs S, Larsen JR, Elliott L, Rodriguez MR, Freemantle N. Long-term real-world effectiveness of allergy immunotherapy in patients with allergic rhinitis and asthma: Results from the REACT study, a retrospective cohort study. Lancet Reg Health Eur. 2021 Nov 30;13:100275. doi: 10.1016/j.lanepe.2021.100275. eCollection 2022 Feb.
- Individual participant dataSharing planned: Undecided
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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.
Mercedes Romano, PharmD, MBA, MSc study director
ALK Abelló
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 Allergy and Respiratory Disease, 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 5 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: finished, as of the sponsor's last update on 2 Jun 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Allergic rhinitis medication use (time frame: From pre-index year to follow-up year(s), assessed from 2007 and up to 2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04125888, which also lists 1 linked publication.
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 2 Jun 2021.