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

NCT04071249 | Completed

• 1 other identifier: Control Validation CSMS 2019
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 7

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.

Conditions

Rhinoconjunctivitis, Allergic

Keywords

Combined Symptom and Medication Score (CSMS); Validation

Outcome Measures

Primary Outcomes (1)

• 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: 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.

  30 to 60 days during allergen exposure

Study Arms (1)

Control

Patients who use symptomatic medication as therapy for their allergic rhinoconjuntivitis as recommended by their physician

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Allergen-specific immunotherapy

Sponsors & Collaborators

• ClinNovis GmbH: lead

Study Sites (7)

Otorhinolaryngology practice

Aachen, Germany

Location

Otorhinolaryngology practice

Bad Schönborn, Germany

Location

Practice for lung and bronchial medicine

Bonn, Germany

Location

Otorhinolaryngology practice

Dresden, Germany

Location

Otorhinolaryngology practice

Duisburg, Germany

Location

Otorhinolaryngology practice

Füssen, Germany

Location

Otorhinolaryngology practice

Schorndorf, Germany

Location

Related Publications (1)

• 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.

  PMID: 24761804 BACKGROUND

Study Officials

• Ralph Moesges, Prof. Dr.

  ClinNovis GmbH, Genter Str. 7, 50672 Cologne, Germany

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: August 28, 2019
• Study Start: October 10, 2019
• Primary Completion: August 25, 2020
• Study Completion: August 25, 2020
• Last Updated: August 26, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (7)