Allergic RhinitistqCPTNCT02690740
Titrated Quantitative Conjunctival Provocation Test (tqCPT)
A study testing (diagnostic) conjunctival provocation test with solution: ALK 100, 1.000, 10.000, 20.000, 50.000 and 100.000 SQ-U/ml in people with Allergic Rhinitis, run by Zentrums für Rhinologie und Allergologie Wiesbaden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- (diagnostic) conjunctival provocation test with solution: ALK 100, 1.000, 10.000, 20.000, 50.000 and 100.000 SQ-U/ml
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
About this study
Official title: 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.
Read the 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
- Being tested
- (diagnostic) conjunctival provocation test with solution: ALK 100, 1.000, 10.000, 20.000, 50.000 and 100.000 SQ-U/ml
- Keywords
- titrated quantitative conjunctival provocation test
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(diagnostic) conjunctival provocation test with solution: ALK 100, 1.000, 10.000, 20.000, 50.000 and 100.000 SQ-U/mlOther
see information in "arm/group descriptions"
| Study group | Role | What they receive |
|---|---|---|
| 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)); Receives: Other: (diagnostic) conjunctival provocation test with solution: ALK 100, 1.000, 10.000, 20.000, 50.000 and 100.000 SQ-U/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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
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.
Measured: 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).
Measured: baseline and re-challenge after 3-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startDec 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zentrums für Rhinologie und Allergologie Wiesbaden
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Cologne
- Responsible party
- Sponsor
- Investigators
- Oliver Pfaar, Prof.Dr., Principal investigator, Allergy Center Wiesbaden, GermanyLudger Klimek, Prof. Dr., Study director, Allergy Center Wiesbaden, GermanyDan Philipp Claßen, Study chair, Allergy Center Wiesbaden, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690740
- Sponsor's protocol ID
- AZ_001_CPT
- Acronym
- tqCPT
- Status last verified
- Feb 2016
- First submitted
- 9 Feb 2016
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29768274
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Titrated Quantitative Conjunctival Provocation Test (tqCPT): Standardization and Validation of a New Clinical Endpoint
- ClinicalTrials.gov ID
- NCT02690740
- Acronym / sponsor ID
- tqCPT / AZ_001_CPT
- Conditions
- Allergic Rhinitis
- Keywords
- titrated quantitative conjunctival provocation test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Zentrums für Rhinologie und Allergologie WiesbadenUniversity, hospital or other
- Collaborators
- University Hospital of Cologne
- Study start
- Dec 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 24 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open label | Experimental | Other: (diagnostic) conjunctival provocation test with solution: ALK 100, 1.000, 10.000, 20.000, 50.000 and 100.000 SQ-U/mltest/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)); |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (diagnostic) conjunctival provocation test with solution: ALK 100, 1.000, 10.000, 20.000, 50.000 and 100.000 SQ-U/mlsee information in "arm/group descriptions" | Other | open label |
Primary outcome
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.
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
- Derived from this study: PubMed 29768274Pfaar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Pfaar, Prof.Dr. principal investigator
Allergy Center Wiesbaden, Germany
Ludger Klimek, Prof. Dr. study director
Allergy Center Wiesbaden, Germany
Dan Philipp Claßen study chair
Allergy Center Wiesbaden, Germany
Questions about this trial
What is this clinical trial studying?
A study testing (diagnostic) conjunctival provocation test with solution: ALK 100, 1.000, 10.000, 20.000, 50.000 and 100.000 SQ-U/ml in people with Allergic Rhinitis, run by Zentrums für Rhinologie und Allergologie Wiesbaden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total conjunctival symptoms provoked by conjunctival provocation test (CPT) at two consecutive settings (time frame: baseline and re-challenge after 3-4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02690740, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2016.