Titrated Quantitative Conjunctival Provocation Test (tqCPT)

NCT02690740 | Completed

• 1 other identifier: AZ_001_CPT
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Allergic Rhinitis

Keywords

titrated quantitative conjunctival provocation test

Outcome Measures

Primary Outcomes (1)

• total conjunctival symptoms provoked by conjunctival provocation test (CPT) at two consecutive settings

  Total Conjunctival symptoms (itching (0-3), irritation (0-3), tearing (0-3), redness (0-3)) provoked by a conjunctival provocation test (CPT) were evaluated and categorized on a 4 point Likert-Scale (Total Score = 0-12 points)) at a first setting and then again after a rechallenge after an interval of 3-4 weeks. Changes of Total score values (0-12 points) of both settings were calculated using the the Pearson and Spearman correlation coefficients.

  baseline and re-challenge after 3-4 weeks

Secondary Outcomes (3)

• Conjunctival redness score (0-3) provoked by conjunctival provocation test (CPT) at two consecutive settings.

  baseline and re-challenge after 3-4 weeks

• difference in the degree of conjunctival redness provoked by conjunctival provocation test (CPT) at two consecutive settings as assessed by digital photo analysis

  baseline and re-challenge after 3-4 weeks

• 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).

  baseline and re-challenge after 3-4 weeks

Study Arms (1)

open label

EXPERIMENTAL

test/retest of a titrated quantitative CPT (TqCPT) with outcomes: CPT-scoring system and correlation with digital photo analysis. in all patients: 1 Arm = CPT test/re-test, no comparator No intervention of a new drug (CPT-solution registered (ALK- Abelló, Hørsholm, Denmark));

Other: (diagnostic) conjunctival provocation test with solution: ALK 100, 1.000, 10.000, 20.000, 50.000 and 100.000 SQ-U/ml

Interventions

(diagnostic) conjunctival provocation test with solution: ALK 100, 1.000, 10.000, 20.000, 50.000 and 100.000 SQ-U/ml OTHER

see information in "arm/group descriptions"

open label

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Zentrums für Rhinologie und Allergologie Wiesbaden: lead
• University Hospital of Cologne: collaborator

Related Publications (1)

• 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.

  PMID: 29768274 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Oliver Pfaar, Prof.Dr.

  Allergy Center Wiesbaden, Germany

  PRINCIPAL INVESTIGATOR

• Ludger Klimek, Prof. Dr.

  Allergy Center Wiesbaden, Germany

  STUDY DIRECTOR

• Dan Philipp Claßen

  Allergy Center Wiesbaden, Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2016
• First Posted: February 24, 2016
• Study Start: December 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: February 24, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share