Titrated Quantitative Conjunctival Provocation Test (tqCPT) (tqCPT)

February 23, 2016 updated by: Zentrums für Rhinologie und Allergologie Wiesbaden

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 67 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: open label

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
see information in "arm/group descriptions"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total conjunctival symptoms provoked by conjunctival provocation test (CPT) at two consecutive settings
Time Frame: baseline and re-challenge after 3-4 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conjunctival redness score (0-3) provoked by conjunctival provocation test (CPT) at two consecutive settings.
Time Frame: baseline and re-challenge after 3-4 weeks
Conjunctival redness provoked by a conjunctival provocation test (CPT) was evaluated and categorized on a 4 point Likert-Scale (0-3) at a first setting and then again after a rechallenge after an interval of 3-4 weeks. Changes of the conjunctival redness score of both settings were calculated using the the Pearson and Spearman correlation coefficients.
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
Time Frame: baseline and re-challenge after 3-4 weeks
Degree of conjunctival redness provoked by conjunctival provocation test (CPT) was assessed by digital photo analysis at a first setting and then after a rechallenge of 3-4 weeks. The percent change in the redness area was determined by a special software program.
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).
Time Frame: baseline and re-challenge after 3-4 weeks
baseline and re-challenge after 3-4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zentrums für Rhinologie und Allergologie Wiesbaden

Collaborators

University Hospital of Cologne

Investigators

  • Principal Investigator: Oliver Pfaar, Prof.Dr., Allergy Center Wiesbaden, Germany
  • Study Director: Ludger Klimek, Prof. Dr., Allergy Center Wiesbaden, Germany
  • Study Chair: Dan Philipp Claßen, Allergy Center Wiesbaden, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

February 9, 2016

First Submitted That Met QC Criteria

February 23, 2016

First Posted (Estimate)

February 24, 2016

Study Record Updates

Last Update Posted (Estimate)

February 24, 2016

Last Update Submitted That Met QC Criteria

February 23, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AZ_001_CPT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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