Clinical trial NCT02690740: Titrated Quantitative Conjunctival Provocation Test (tqCPT)
Official title: Titrated Quantitative Conjunctival Provocation Test (tqCPT): Standardization and Validation of a New Clinical Endpoint
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Rhinitis
Keywords: titrated quantitative conjunctival provocation test
Lead sponsor: Zentrums für Rhinologie und Allergologie Wiesbaden
Sponsor class: OTHER
Collaborators: name: University Hospital of Cologne
First posted: 2016-02-24
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: Inclusion Criteria:

* moderate to severe allergic rhinoconjunctivitis (ARC) symptoms in preceding two years -intake of anti-allergic medication in the preceding two years -positive test result in skin prick test (SPT) (wheal size at least 3 mm larger than the negative control). -
* retrospective global symptoms score (≥5 out of 12)

Exclusion Criteria:

* acute diseases of the eye or of the nose/nasal sinuses,
* persistent allergy
* intake of concomitant (antiallergic) medication prior to CPT-challenges
* CPT score ≥3 during the examination of the control (non-challenged eye) at baseline

Primary outcomes:
measure: total conjunctival symptoms provoked by conjunctival provocation test (CPT) at two consecutive settings
timeFrame: baseline and re-challenge after 3-4 weeks
Secondary outcomes:
measure: Conjunctival redness score (0-3) provoked by conjunctival provocation test (CPT) at two consecutive settings.
timeFrame: baseline and re-challenge after 3-4 weeks
measure: difference in the degree of conjunctival redness provoked by conjunctival provocation test (CPT) at two consecutive settings as assessed by digital photo analysis
timeFrame: baseline and re-challenge after 3-4 weeks
measure: Correlation of the degree of conjunctival redness as assessed by digital photo analysis with the conjunctival redness score evaluated and categorized on a 4 point Likert-Scale (0-3) provoked by a conjunctival provocation test (CPT).
timeFrame: baseline and re-challenge after 3-4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Allergy Center Wiesbaden, Germany
name: Oliver Pfaar, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Allergy Center Wiesbaden, Germany
name: Ludger Klimek, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Allergy Center Wiesbaden, Germany
name: Dan Philipp Claßen
role: STUDY_CHAIR
References:
citation: Pfaar O, Classen DP, Astvatsatourov A, Klimek L, Mosges R. Reliability of a New Symptom Score in a Titrated Quantitative Conjunctival Provocation Test Supported by an Objective Photodocumentation. Int Arch Allergy Immunol. 2018;176(3-4):215-224. doi: 10.1159/000487884. Epub 2018 May 16.