Validation of a Combined Symptom and Medication Score in Patients Suffering From Allergic Rhinoconjunctivitis

Rhinoconjunctivitis, Allergic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04071249
• Other study ID #: Control Validation CSMS 2019
• Status: Completed
• Start date: October 10, 2019
• Est. completion date: August 25, 2020

Study information

• Verified date: August 2020
• Source: ClinNovis GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: August 25, 2020
• Est. primary completion date: August 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Conjunctivitis
• Rhinoconjunctivitis, Allergic

Locations

Country	Name	City	State
Germany	Otorhinolaryngology practice	Aachen
Germany	Otorhinolaryngology practice	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

Sponsors (1)

Lead Sponsor	Collaborator
ClinNovis GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Pfaar O, Demoly P, Gerth van Wijk R, Bonini S, Bousquet J, Canonica GW, Durham SR, Jacobsen L, Malling HJ, Mösges 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 to 60 days during allergen exposure