NCT02690740

Titrated Quantitative Conjunctival Provocation Test (tqCPT)

Titrated Quantitative Conjunctival Provocation Test (tqCPT): Standardization and Validation of a New Clinical Endpoint

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Zentrums für Rhinologie und Allergologie Wiesbaden · Academic / Other
• Sex: All
• Age: 18 Years – 67 Years
• Healthy volunteers: Not accepted

Summary

The clinical relevance of an allergen-specific sensitization is proven e.g., by allergen challenge tests in clinical routine. Several protocols for different challenge tests such as nasal (NPT), bronchial (BPT) or conjunctival provocation test (CPT) have been proposed. Beneath others, the CPT is broadly used in both clinical trials and routine because of its feasibility. However, there is no internationally harmonized standard regarding the clinical interpretation of CPT results as well as a lack of validation of a specific outcome score. Therefore, this trial aims to investigate and validate a new scoring system for CPT results in order to provide this test as a useful method in future clinical trials.

Detailed description

Of 33 patients who had been initially screened, ten patients did not fulfill all of the inclusion criteria mentioned hereafter. Thus, 23 patients aged 18 to 67 years having a birch and/or grass pollen allergy were included in the analysis. The study is in line with the Declaration of Helsinki and is approved by the responsible ethics committee (FF 118/2012 (4 December 2012); Landesärztekammer Hessen, Frankfurt, Germany). All participating patients are informed of the nature and objectives of the study and signed an informed consent document. The CPT is conducted using standardized and registered allergen extracts (ALK- Abelló, Hørsholm, Denmark). At the first visit, a titrated quantitative CPT (tqCPT) is performed according to a standardized protocol. In case of a positive test result, CPT-results are to be confirmed at a re-challenge one week later. The final CPT takes place 3 to 4 weeks after the 2nd (confirmatory) challenge for analyzing the primary objective of the trial: reproducibility of the CPT symptom score. Furthermore, objective evaluation of the clinical reactions after the tqCPT is documented using a MATLAB software program to calculate the degree of redness in percent. This is then correlated with the (subjective) main investigators' evaluations and with the external observer's evaluations.

Conditions

• Allergic Rhinitis

Interventions

Type	Name	Description
OTHER	(diagnostic) conjunctival provocation test with solution: ALK 100, 1.000, 10.000, 20.000, 50.000 and 100.000 SQ-U/ml	see information in "arm/group descriptions"

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2016-02-24
• Last updated: 2016-02-24