Clinical trial NCT04071249: Validation of a Combined Symptom and Medication Score in Patients Suffering From Allergic Rhinoconjunctivitis
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinoconjunctivitis, Allergic
Keywords: Combined Symptom and Medication Score (CSMS)
Validation
Lead sponsor: ClinNovis GmbH
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 55
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Allergen-specific immunotherapy

Primary outcomes:
measure: Combined Symptom and Medication Score (CSMS)
timeFrame: 30 to 60 days during allergen exposure
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Otorhinolaryngology practice
city: Bad Schönborn
country: Germany
facility: Otorhinolaryngology practice
city: Bonn
country: Germany
facility: Practice for lung and bronchial medicine
city: Dresden
country: Germany
facility: Otorhinolaryngology practice
city: Duisburg
country: Germany
facility: Otorhinolaryngology practice
city: Füssen
country: Germany
facility: Otorhinolaryngology practice
city: Schorndorf
country: Germany
facility: Otorhinolaryngology practice
Study officials:
affiliation: ClinNovis GmbH, Genter Str. 7, 50672 Cologne, Germany
name: Ralph Moesges, Prof. Dr.
role: STUDY_CHAIR
References:
citation: 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.