Rhinoconjunctivitis, AllergicNCT04071249
Validation of a Combined Symptom and Medication Score in Patients Suffering From Allergic Rhinoconjunctivitis
An observational study of Rhinoconjunctivitis, Allergic, run by ClinNovis GmbH at 7 sites in Germany.
Trial summary
This study is a mere data collection without predefined intervention. Patients aged 12 years or older who suffer from allergic rhinitis induced by house dust mites, tree pollen or grass pollen and who are treated exclusively with anti-allergic medication may take part. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Rhinoconjunctivitis, Allergic
- How many people
- 55 participants
- Where
- 7 sitesGermany
- Study dates
- 10 Oct 2019to 25 Aug 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: Patients aged 12 years or older who suffer from allergic rhinoconjunctivitis induced by house dust mites, tree pollen or grass pollen and who are treated exclusively with symptomatic medication
Who may be able to join
- Patients aged 12 years or older who suffer from allergic rhinoconjunctivitis induced by house dust mites, tree pollen or grass pollen and who are treated exclusively with symptomatic medication
Who cannot join
- Allergen-specific immunotherapy
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Otorhinolaryngology practice
Aachen
Otorhinolaryngology practice
Bad Schönborn
Practice for lung and bronchial medicine
Bonn
Otorhinolaryngology practice
Dresden
Otorhinolaryngology practice
Duisburg
Otorhinolaryngology practice
Füssen
Otorhinolaryngology practice
Schorndorf
About this study
Official title: Validation of the Combined Symptom and Medication Score (CSMS) in Patients Suffering From Allergic Rhinoconjunctivitis Induced by Tree Pollen, Grass Pollen or House Dust Mites Who Are Treated Exclusively With Symptomatic Medication
This study is a mere data collection without predefined intervention. Patients aged 12 years or older who suffer from allergic rhinitis induced by house dust mites, tree pollen or grass pollen and who are treated exclusively with anti-allergic medication may take part. The treatment follows the normal medical practice in accordance with national medical guidelines. During the study, data are collected during 3 visits with regard to allergic complaints of a patient and intake of anti-allergic medication. The first visit takes place before allergen exposure, the second visit at the peak of allergen exposure and the third visit after allergen exposure. The allergen exposure is defined as the enhanced exposure to house dust mites during the heating period or the respective pollen season. During the visits, the patients will be asked to complete questionnaires with regard to their quality of life and rhinitis control. Furthermore during allergen exposure, the patients document their allergic complaints and intake of anti-allergic medication in a diary. The diary entries are used to generate the Combined Symptom and Medication Score (CSMS) which will be validated in the course of this study. The validation will be performed by comparing the CSMS with the scores from the already validated questionnaires.
Read the detailed description
This study is a prospective, mulit-center data collection without predefined intervention. Patients aged 12 years or older who suffer from allergic rhinoconjunctivitis induced by house dust mites, tree pollen or grass pollen and who are treated exclusively with symptomatic medication may take part. The treatment follows the normal medical practice in accordance with national medical guidelines. During the study, data are collected during 3 visits with regard to allergic symptoms of a patient and intake of symptomatic medication. The first visit takes place before allergen exposure, the second visit at the peak of allergen exposure and the third visit after allergen exposure. The allergen exposure ist defined as the enhanced exposure to house dust mites during the heating period or the respective pollen season. During the visits, the patients will be asked to complete questionnaires [the rhinitis quality of life questionnaire (RQLQ, Visit 1, 2 and 3) and the rhinitis control assessment test (RCAT, visit 2)]. Furthermore during allergen exposure, the patients document allergic symptoms and intake of symptomatic medication in a diary. These diary entries are used to generate the Combined Symptom and Medication Score (CSMS) which will be validated in the course of this study. The validation will be performed by comparing the CSMS with the scores from the already validated RQLQ and RCAT.
- Conditions
- Rhinoconjunctivitis, Allergic
- Keywords
- Combined Symptom and Medication Score (CSMS), Validation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Patients who use symptomatic medication as therapy for their allergic rhinoconjuntivitis as recommended by their physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined Symptom and Medication Score (CSMS)
The CSMS describes the severity of nasal and conjunctival symptoms of allergic rhinoconjunctivitis as well as the intake of symptomatic medication.
Four nasal and two conjunctival symptoms (itchy nose, sneezing, runny nose, blocked nose, itchy/red eyes, watery eyes) are evaluated using a score from 0 to 3 (0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms).
The stepwise use of medication will be assessed as follows:
- = Oral and/or topical (eyes or nose) nonsedative H1 antihistamines (H1A)
- = Intranasal corticosteroids (INS) with/without H1A
- = Oral corticosteroids with/without INS, with/without H1A
The combination of symptom and medication score based on an equal weight generates the daily CSMS with a range from 0 to 6.
Measured: 30 to 60 days during allergen exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start10 Oct 2019
- Primary completion25 Aug 2020
- Study completion25 Aug 2020
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 Rhinoconjunctivitis, AllergicStudies 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
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- ClinNovis GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ralph Moesges, Prof. Dr., Study chair, ClinNovis GmbH, Genter Str. 7, 50672 Cologne, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071249
- Sponsor's protocol ID
- Control Validation CSMS 2019
- Status last verified
- Aug 2020
- First submitted
- 26 Aug 2019
- Last updated
- 26 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pfaar O, Demoly P, Gerth van Wijk R, Bonini S, Bousquet J, Canonica GW, Durham SR, Jacobsen L, Malling HJ, Mosges R, Papadopoulos NG, Rak S, Rodriguez del Rio P, Valovirta E, Wahn U, Calderon MA; European Academy of Allergy and Clinical Immunology. Recommendations for the standardization of clinical outcomes used in allergen immunotherapy trials for allergic rhinoconjunctivitis: an EAACI Position Paper. Allergy. 2014 Jul;69(7):854-67. doi: 10.1111/all.12383. Epub 2014 Apr 25.
PubMed 24761804
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Combined Symptom and Medication Score (CSMS) in Patients Suffering From Allergic Rhinoconjunctivitis Induced by Tree Pollen, Grass Pollen or House Dust Mites Who Are Treated Exclusively With Symptomatic Medication
- ClinicalTrials.gov ID
- NCT04071249
- Acronym / sponsor ID
- Control Validation CSMS 2019
- Conditions
- Rhinoconjunctivitis, Allergic
- Keywords
- Combined Symptom and Medication Score (CSMS), Validation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- ClinNovis GmbHUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 25 Aug 2020 (actual)
- Study completion
- 25 Aug 2020 (actual)
- First posted
- 28 Aug 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.
This study is a mere data collection without predefined intervention. Patients aged 12 years or older who suffer from allergic rhinitis induced by house dust mites, tree pollen or grass pollen and who are treated exclusively with anti-allergic medication may take part. The treatment follows the normal medical practice in accordance with national medical guidelines. During the study, data are collected during 3 visits with regard to allergic complaints of a patient and intake of anti-allergic medication. The first visit takes place before allergen exposure, the second visit at the peak of allergen exposure and the third visit after allergen exposure. The allergen exposure is defined as the enhanced exposure to house dust mites during the heating period or the respective pollen season. During the visits, the patients will be asked to complete questionnaires with regard to their quality of life and rhinitis control. Furthermore during allergen exposure, the patients document their allergic complaints and intake of anti-allergic medication in a diary. The diary entries are used to generate the Combined Symptom and Medication Score (CSMS) which will be validated in the course of this study. The validation will be performed by comparing the CSMS with the scores from the already validated questionnaires.
Detailed description
This study is a prospective, mulit-center data collection without predefined intervention. Patients aged 12 years or older who suffer from allergic rhinoconjunctivitis induced by house dust mites, tree pollen or grass pollen and who are treated exclusively with symptomatic medication may take part. The treatment follows the normal medical practice in accordance with national medical guidelines. During the study, data are collected during 3 visits with regard to allergic symptoms of a patient and intake of symptomatic medication. The first visit takes place before allergen exposure, the second visit at the peak of allergen exposure and the third visit after allergen exposure. The allergen exposure ist defined as the enhanced exposure to house dust mites during the heating period or the respective pollen season. During the visits, the patients will be asked to complete questionnaires [the rhinitis quality of life questionnaire (RQLQ, Visit 1, 2 and 3) and the rhinitis control assessment test (RCAT, visit 2)]. Furthermore during allergen exposure, the patients document allergic symptoms and intake of symptomatic medication in a diary. These diary entries are used to generate the Combined Symptom and Medication Score (CSMS) which will be validated in the course of this study. The validation will be performed by comparing the CSMS with the scores from the already validated RQLQ and RCAT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Patients who use symptomatic medication as therapy for their allergic rhinoconjuntivitis as recommended by their physician |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients aged 12 years or older who suffer from allergic rhinoconjunctivitis induced by house dust mites, tree pollen or grass pollen and who are treated exclusively with symptomatic medication
Key inclusion criteria (1 listed)
- Patients aged 12 years or older who suffer from allergic rhinoconjunctivitis induced by house dust mites, tree pollen or grass pollen and who are treated exclusively with symptomatic medication
Key exclusion criteria (1 listed)
- Allergen-specific immunotherapy
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
Combined Symptom and Medication Score (CSMS)
Time frame: 30 to 60 days during allergen exposure
The CSMS describes the severity of nasal and conjunctival symptoms of allergic rhinoconjunctivitis as well as the intake of symptomatic medication. Four nasal and two conjunctival symptoms (itchy nose, sneezing, runny nose, blocked nose, itchy/red eyes, watery eyes) are evaluated using a score from 0 to 3 (0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms). The stepwise use of medication will be assessed as follows: 1. = Oral and/or topical (eyes or nose) nonsedative H1 antihistamines (H1A) 2. = Intranasal corticosteroids (INS) with/without H1A 3. = Oral corticosteroids with/without INS, with/without H1A The combination of symptom and medication score based on an equal weight generates the daily CSMS with a range from 0 to 6.
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 Aug 2020.
- Background: PubMed 24761804Pfaar O, Demoly P, Gerth van Wijk R, Bonini S, Bousquet J, Canonica GW, Durham SR, Jacobsen L, Malling HJ, Mosges R, Papadopoulos NG, Rak S, Rodriguez del Rio P, Valovirta E, Wahn U, Calderon MA; European Academy of Allergy and Clinical Immunology. Recommendations for the standardization of clinical outcomes used in allergen immunotherapy trials for allergic rhinoconjunctivitis: an EAACI Position Paper. Allergy. 2014 Jul;69(7):854-67. doi: 10.1111/all.12383. Epub 2014 Apr 25.
- 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 Moesges, Prof. Dr. study chair
ClinNovis GmbH, Genter Str. 7, 50672 Cologne, Germany
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhinoconjunctivitis, Allergic, run by ClinNovis GmbH at 7 sites 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 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Combined Symptom and Medication Score (CSMS) (time frame: 30 to 60 days during allergen exposure). 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 NCT04071249, 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 26 Aug 2020.