Allergic RhinoconjunctivitisNCT03850626
Validation of Combined Symptom Medication Score (cSMS) in Allergic Patients
An observational study of Allergic Rhinoconjunctivitis and Allergic Asthma, run by Leti Pharma GmbH at 1 site in Germany.
Trial summary
The CSMS was defined by the European Academy of Allergy and Immunology Taskforce as a standardised tool to assess clinical effects of allergen-specific immunotherapy (AIT). The aim of this study is to validate the CSMS as a tool to assess the clinical effects of Depigoid AIT, so that the CSMS can be used in future… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Allergic Rhinoconjunctivitis, Allergic Asthma
- What is being tested?
- Immunotherapy
- Type of treatment
- Injection or infusion
- How many people
- 168 participants
- Where
- 1 siteGermany
- Study dates
- 9 Sep 2018to 3 Sep 2020
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: adults and adolescents suffering from allergic diseases (rhinitis, rhinoconjunctivitis, with or without concomitant asthma)
Who may be able to join
- Indication of an allergen-specific immunotherapy with Depigoid
Who cannot join
- exclusion criteria according to the SmPC
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validierung Des cSMS in Patienten Mit Allergischer Rhinokonjunktivitis (Baum- Und Gräserpollen, Hausstaubmilben). - Eine NIS Bei Patienten, Die Depigoid® Als Spezifische Immuntherapie Erhalten
The CSMS was defined by the European Academy of Allergy and Immunology Taskforce as a standardised tool to assess clinical effects of allergen-specific immunotherapy (AIT). The aim of this study is to validate the CSMS as a tool to assess the clinical effects of Depigoid AIT, so that the CSMS can be used in future studies as a primary endpoint as well as a comparative parameter.
Read the detailed description
Approximately 20% of the general public suffer from seasonal or perennial allergic rhinoconjunctivitis. The only available curative therapy is AIT. The effectiveness of AIT was demonstrated in numerous randomized clinical trials but comparability is difficult because of different primary and secondary endpoints.
To validate the CSMS, adolescent (≥ 12 years) and adult patients will be observed who are allergic to house dust mites (HDM), tree or grass pollen and who were treated with Depigoid. Depigoid is a registered (for tree and grass pollen) respective authorized (for HDM) suspension for injection for the treatment of immediate type allergic diseases. Depigoid contains depigmented and chemically modified allergen extracts, so called allergoids, derived from grass pollen, tree pollen or HDM.
Allergy symptoms will be documented over a time period of two years: Either for two consecutive allergy seasons (for tree and grass pollen allergic patients) or for two consecutive exposure periods (September-December) for HDM allergic patients. The symptoms (4 nasal and 2 ocular symptoms) and allergy medication intake will be documented on a daily basis either using the CSMS questionnaire or the especially developed electronic CSMS+ diary application.
Already validated and established questionnaires will be used to validate the CSMS with regard to Quality of Life (QoL) and symptom control: the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), Adolescent RQLQ (AdolRQLQ, for patients aged 12-17 years), Asthma Quality of Life Questionnaire (AQLQ) and AQLQ for patients aged 12 years and older (AQLQ+12), the Asthma Control Test (ACT), Rhinitis Control Assessment Test (RCAT) and the Visual Analogue Scale (VAS).
- Conditions
- Allergic Rhinoconjunctivitis, Allergic Asthma
- Being tested
- Immunotherapy
- Keywords
- Allergy, Rhinoconjuctivitis, Combined Symptom and Medication Score, Allergic Asthma, Pollen, Mites
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunotherapyBiological
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Immunotherapy Trees | Patients allergic to tree pollen Receives: Biological: Immunotherapy | |
| Immunotherapy Grass | Patients allergic to grass pollen Receives: Biological: Immunotherapy | |
| Immunotherapy Mites | Patients allergic to HDM Receives: Biological: Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
cSMS
Combined Symptom and Medication Score
Measured: after up to 60 days during allergen exposure period (=pollen season resp. allergen season) in 2 consecutive years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start9 Sep 2018
- Primary completion3 Sep 2020
- Study completion3 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinoconjunctivitisStudies 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
- Prospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leti Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Angelika Sager, Dr.med., Study director, Medical Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03850626
- Sponsor's protocol ID
- cSMS-2018
- Status last verified
- Mar 2021
- First submitted
- 18 Feb 2019
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validierung Des cSMS in Patienten Mit Allergischer Rhinokonjunktivitis (Baum- Und Gräserpollen, Hausstaubmilben). - Eine NIS Bei Patienten, Die Depigoid® Als Spezifische Immuntherapie Erhalten
- ClinicalTrials.gov ID
- NCT03850626
- Acronym / sponsor ID
- cSMS-2018
- Conditions
- Allergic Rhinoconjunctivitis, Allergic Asthma
- Keywords
- Allergy, Rhinoconjuctivitis, Combined Symptom and Medication Score, Allergic Asthma, Pollen, Mites
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Leti Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2018 (actual)
- Primary completion
- 3 Sep 2020 (actual)
- Study completion
- 3 Sep 2020 (actual)
- First posted
- 22 Feb 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 CSMS was defined by the European Academy of Allergy and Immunology Taskforce as a standardised tool to assess clinical effects of allergen-specific immunotherapy (AIT). The aim of this study is to validate the CSMS as a tool to assess the clinical effects of Depigoid AIT, so that the CSMS can be used in future studies as a primary endpoint as well as a comparative parameter.
Detailed description
Approximately 20% of the general public suffer from seasonal or perennial allergic rhinoconjunctivitis. The only available curative therapy is AIT. The effectiveness of AIT was demonstrated in numerous randomized clinical trials but comparability is difficult because of different primary and secondary endpoints.
To validate the CSMS, adolescent (≥ 12 years) and adult patients will be observed who are allergic to house dust mites (HDM), tree or grass pollen and who were treated with Depigoid. Depigoid is a registered (for tree and grass pollen) respective authorized (for HDM) suspension for injection for the treatment of immediate type allergic diseases. Depigoid contains depigmented and chemically modified allergen extracts, so called allergoids, derived from grass pollen, tree pollen or HDM.
Allergy symptoms will be documented over a time period of two years: Either for two consecutive allergy seasons (for tree and grass pollen allergic patients) or for two consecutive exposure periods (September-December) for HDM allergic patients. The symptoms (4 nasal and 2 ocular symptoms) and allergy medication intake will be documented on a daily basis either using the CSMS questionnaire or the especially developed electronic CSMS+ diary application.
Already validated and established questionnaires will be used to validate the CSMS with regard to Quality of Life (QoL) and symptom control: the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), Adolescent RQLQ (AdolRQLQ, for patients aged 12-17 years), Asthma Quality of Life Questionnaire (AQLQ) and AQLQ for patients aged 12 years and older (AQLQ+12), the Asthma Control Test (ACT), Rhinitis Control Assessment Test (RCAT) and the Visual Analogue Scale (VAS).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Immunotherapy Trees | – | Biological: ImmunotherapyPatients allergic to tree pollen |
| Immunotherapy Grass | – | Biological: ImmunotherapyPatients allergic to grass pollen |
| Immunotherapy Mites | – | Biological: ImmunotherapyPatients allergic to HDM |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- adults and adolescents suffering from allergic diseases (rhinitis, rhinoconjunctivitis, with or without concomitant asthma)
Key inclusion criteria (1 listed)
- Indication of an allergen-specific immunotherapy with Depigoid
Key exclusion criteria (1 listed)
- exclusion criteria according to the SmPC
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 |
|---|---|---|
| Immunotherapysubcutaneous injection | Biological | Immunotherapy Grass, Immunotherapy Mites, Immunotherapy Trees |
Primary outcome
cSMS
Time frame: after up to 60 days during allergen exposure period (=pollen season resp. allergen season) in 2 consecutive years
Combined Symptom and Medication Score
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 26 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Angelika Sager, Dr.med. study director
Medical Department
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 Rhinoconjunctivitis and Allergic Asthma, run by Leti Pharma GmbH 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 26 Mar 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 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?
cSMS (time frame: after up to 60 days during allergen exposure period (=pollen season resp. allergen season) in 2 consecutive years). 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 26 Mar 2021.