Allergic RhinitisNCT02609581
Tolerability of SLIT With LAIS® Mites Allergoid Tablets
An observational study of Allergic Rhinitis, run by University Hospital of Cologne.
Trial summary
To expand knowledge on the application and tolerability of immunotherapy with LAIS® Mites 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 18 years and older
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Sublingual Immunotherapy with tablets (mites)
- Type of treatment
- Pill or oral medicine
- How many people
- 192 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2015to 28 Feb 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 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 (mites).
Who may be able to join
- Patients aged 18 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
About this study
Official title: Non-Interventional Study (NIS) on the Tolerability of Sublingual Immunotherapy With LAIS® Mites Tablets in Consideration of the Chosen Titration Schedule in Everyday Practice
To expand knowledge on the application and tolerability of immunotherapy with LAIS® Mites 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® Mites 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® Mites 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
- Being tested
- Sublingual Immunotherapy with tablets (mites)
- Keywords
- Non Interventional Study, NIS, sublingual immunotherapy, allergen, Mites
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sublingual Immunotherapy with tablets (mites)Drug
Also called Sublingual immunotherapy
Sublingual immunotherapy involves putting a tablet of allergen extracts (mites) under the tongue to swallow the extract.
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® mites 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® mites tablets and actions taken due to the treatment with LAIS® mites tablets and other concomitant medication. The documentation of adverse events takes place at visit 1, at visit 2 (after titrationphase) and at visit 3 (after first year of treatment).
Measured: 13 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study start1 Dec 2015
- Primary completion28 Feb 2017
- Study completion28 Feb 2017
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
- Other
- Time perspective
- Prospective
- Enrolment
- 192 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, Prof. Dr., Principal investigator, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609581
- Sponsor's protocol ID
- LF HDM/Titra/2015/D
- Status last verified
- Oct 2017
- First submitted
- 17 Nov 2015
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. 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® Mites Tablets in Consideration of the Chosen Titration Schedule in Everyday Practice
- ClinicalTrials.gov ID
- NCT02609581
- Acronym / sponsor ID
- LF HDM/Titra/2015/D
- Conditions
- Allergic Rhinitis
- Keywords
- Non Interventional Study, NIS, sublingual immunotherapy, allergen, Mites
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- University Hospital of CologneUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 20 Nov 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® Mites 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® Mites 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® Mites 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
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 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 (mites).
Key inclusion criteria (1 listed)
- Patients aged 18 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sublingual Immunotherapy with tablets (mites)Also: Sublingual immunotherapySublingual immunotherapy involves putting a tablet of allergen extracts (mites) under the tongue to swallow the extract. | Drug | – |
Primary outcome
Assessment of the tolerability of SLIT with LAIS® mites allergoid tablets on the description of adverse events and serious adverse events.
Time frame: 13 month
The description of adverse events/serious adverse events (AE/SAE) encompasses frequency, intensity, duration, relationship to LAIS® mites tablets and actions taken due to the treatment with LAIS® mites tablets and other concomitant medication. The documentation of adverse events takes place at visit 1, at visit 2 (after titrationphase) and at visit 3 (after first year of treatment).
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 25 Oct 2017.
- Individual participant dataSharing planned: No
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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, Prof. Dr. principal investigator
University Hospital of Cologne
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinitis, run by University Hospital of Cologne.
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 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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® mites allergoid tablets on the description of adverse events and serious adverse events. (time frame: 13 month). 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 25 Oct 2017.