Allergic RhinitisNCT02553590
Tolerability of SLIT With LAIS® 2-Tree Allergoid Tablets
An observational study of Allergic Rhinitis, run by University Hospital of Cologne at 1 site in Germany.
Trial summary
To expand knowledge on the application and tolerability of immunotherapy with LAIS® 2-tree allergoid tablets as well as knowledge on the alleviation of symptoms during sublingual therapy in special consideration of the chosen titration schedule in everyday practice. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Allergic Rhinitis
- How many people
- 160 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2015to Oct 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients aged 5 years or older can be enrolled in the NIS if sublingual specific immunotherapy has been indicated due to allergic rhinoconjunctivitis or allergic bronchial asthma induced by the allergens to be investigated (birch and/or alder).
Who may be able to join
- Patients aged 5 years or older having allergies within the scope of specifications stated in the patient information leaflet
Who cannot join
- Contraindications according to the patient information leaflet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-Interventional Study (NIS) on the Tolerability of Sublingual Immunotherapy With LAIS® 2-Tree Tablets in Consideration of the Chosen Titration Schedule in Everyday Practice
To expand knowledge on the application and tolerability of immunotherapy with LAIS® 2-tree allergoid tablets as well as knowledge on the alleviation of symptoms during sublingual therapy in special consideration of the chosen titration schedule in everyday practice.
Read the detailed description
Until now, results from controlled studies with their specific requirements (patient selection, defined inclusion and exclusion criteria, close patient management and monitoring, randomisation) are available for LAIS® 2-tree allergoid tablets only for a small patient population. In addition, an open-label, controlled study and an observational study have been carried out investigating the clinical efficacy and tolerability of the preparation. Owing to the differences in the study designs, the allergen dose administered and the frequency with which the preparation was applied varied among the individual studies, making it necessary to gather further data on the safety and tolerability of the preparation in a larger patient population.
The observation schedule of this NIS (NIS in accordance with Article 67 Paragraph 6 of the German Medicinal Products Act (AMG)), which takes into account the recommendations made by the German Federal Institute for Drugs and Medical Devices (BfArM) and by the Paul Ehrlich Institute for planning, implementing and evaluating an NIS, is geared to the routine procedure carried out for patients with allergies to tree pollen.
The aim of this observational study is to observe and document the tolerability and improvement of symptoms after treatment with LAIS® 2-tree allergoid tablets under normal application conditions and in consideration of the chosen titration schedule in therapeutic practice - in accordance with the patient information leaflet - in a large patient population:
- Retrospective survey of rhinitis/rhinoconjunctivitis symptoms induced by tree pollen
- Overall symptomatology
- Documentation of restrictions caused by allergy/asthma
- Tolerability of the treatment by means of AE documentation
- Patient compliance
Additional requirements extending beyond the specifications listed in the patient information leaflet on product use, patient groups, dosage, contraindications, etc., will not be made.
- Conditions
- Allergic Rhinitis
- Keywords
- Non Interventional Study, NIS, sublingual immunotherapy, allergen, tree, birch, alder
- Medical subject headings
- Rhinitis, Allergic
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the tolerability of SLIT with LAIS® 2-tree allergoid tablets on the description of adverse events and serious adverse events.
The description of adverse events/serious adverse events (AE/SAE) encompasses frequency, intensity, duration, relationship to LAIS® 2-tree tablets and actions taken due to the treatment with LAIS® 2-tree tablets and other concomitant medication. The documentation of adverse events takes place at visit 1 (before the tree pollen season), at visit 2 (at the peak tree pollen season) and at visit 3 (after the tree pollen season).
Measured: 7 months
Assessment of the tolerability of SLIT with LAIS® 2-tree allergoid tablets on the judgement of the treatment by the investigator and the patient.
The tolerability of the treatment was judged by the investigator and the patient at visit 2 using a 4-point scale: very well - good - moderate - bad.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startJan 2015
- Primary completionOct 2015
- Study completionOct 2015
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
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Ralph Mösges, University Hospital of Cologne
- Investigators
- Ralph Mösges, Professor, Principal investigator, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02553590
- Sponsor's protocol ID
- LF 2B/Titra/2014/D
- Status last verified
- Nov 2015
- First submitted
- 24 Aug 2015
- Last updated
- 11 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Interventional Study (NIS) on the Tolerability of Sublingual Immunotherapy With LAIS® 2-Tree Tablets in Consideration of the Chosen Titration Schedule in Everyday Practice
- ClinicalTrials.gov ID
- NCT02553590
- Acronym / sponsor ID
- LF 2B/Titra/2014/D
- Conditions
- Allergic Rhinitis
- Keywords
- Non Interventional Study, NIS, sublingual immunotherapy, allergen, tree, birch, alder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University Hospital of CologneUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 17 Sep 2015 (estimated)
- 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.
To expand knowledge on the application and tolerability of immunotherapy with LAIS® 2-tree allergoid tablets as well as knowledge on the alleviation of symptoms during sublingual therapy in special consideration of the chosen titration schedule in everyday practice.
Detailed description
Until now, results from controlled studies with their specific requirements (patient selection, defined inclusion and exclusion criteria, close patient management and monitoring, randomisation) are available for LAIS® 2-tree allergoid tablets only for a small patient population. In addition, an open-label, controlled study and an observational study have been carried out investigating the clinical efficacy and tolerability of the preparation. Owing to the differences in the study designs, the allergen dose administered and the frequency with which the preparation was applied varied among the individual studies, making it necessary to gather further data on the safety and tolerability of the preparation in a larger patient population.
The observation schedule of this NIS (NIS in accordance with Article 67 Paragraph 6 of the German Medicinal Products Act (AMG)), which takes into account the recommendations made by the German Federal Institute for Drugs and Medical Devices (BfArM) and by the Paul Ehrlich Institute for planning, implementing and evaluating an NIS, is geared to the routine procedure carried out for patients with allergies to tree pollen.
The aim of this observational study is to observe and document the tolerability and improvement of symptoms after treatment with LAIS® 2-tree allergoid tablets under normal application conditions and in consideration of the chosen titration schedule in therapeutic practice - in accordance with the patient information leaflet - in a large patient population:
- Retrospective survey of rhinitis/rhinoconjunctivitis symptoms induced by tree pollen
- Overall symptomatology
- Documentation of restrictions caused by allergy/asthma
- Tolerability of the treatment by means of AE documentation
- Patient compliance
Additional requirements extending beyond the specifications listed in the patient information leaflet on product use, patient groups, dosage, contraindications, etc., will not be made.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients aged 5 years or older can be enrolled in the NIS if sublingual specific immunotherapy has been indicated due to allergic rhinoconjunctivitis or allergic bronchial asthma induced by the allergens to be investigated (birch and/or alder).
Key inclusion criteria (1 listed)
- Patients aged 5 years or older having allergies within the scope of specifications stated in the patient information leaflet
Key exclusion criteria (1 listed)
- Contraindications according to the patient information leaflet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of the tolerability of SLIT with LAIS® 2-tree allergoid tablets on the description of adverse events and serious adverse events.
Time frame: 7 months
The description of adverse events/serious adverse events (AE/SAE) encompasses frequency, intensity, duration, relationship to LAIS® 2-tree tablets and actions taken due to the treatment with LAIS® 2-tree tablets and other concomitant medication. The documentation of adverse events takes place at visit 1 (before the tree pollen season), at visit 2 (at the peak tree pollen season) and at visit 3 (after the tree pollen season).
Assessment of the tolerability of SLIT with LAIS® 2-tree allergoid tablets on the judgement of the treatment by the investigator and the patient.
Time frame: 7 months
The tolerability of the treatment was judged by the investigator and the patient at visit 2 using a 4-point scale: very well - good - moderate - bad.
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 11 Nov 2015.
Related trials for Allergic Rhinitis
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Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
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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.
Ralph Mösges, Professor principal investigator
University Hospital of Cologne
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 University Hospital of Cologne at 1 site in Germany.
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 1 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 11 Nov 2015. 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 Germany. 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?
Assessment of the tolerability of SLIT with LAIS® 2-tree allergoid tablets on the description of adverse events and serious adverse events. (time frame: 7 months). The study lists 2 primary outcomes in all. 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 11 Nov 2015; AzTrials last refreshed its copy on 2 Nov 2026.