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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Patients who use symptomatic medication as therapy for their allergic rhinoconjuntivitis as recommended by their physician |
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| Measure | Description | Time Frame |
|---|---|---|
| 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:
The combination of symptom and medication score based on an equal weight generates the daily CSMS with a range from 0 to 6. | 30 to 60 days during allergen exposure |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Ralph Moesges, Prof. Dr. | ClinNovis GmbH, Genter Str. 7, 50672 Cologne, Germany | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Otorhinolaryngology practice | Aachen | Germany | ||||
| Otorhinolaryngology practice |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24761804 | Background | 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. |
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| Bad Schönborn |
| Germany |
| Practice for lung and bronchial medicine | Bonn | Germany |
| Otorhinolaryngology practice | Dresden | Germany |
| Otorhinolaryngology practice | Duisburg | Germany |
| Otorhinolaryngology practice | Füssen | Germany |
| Otorhinolaryngology practice | Schorndorf | Germany |