Allergic RhinitisSPTTapeD1NCT03820154
Diagnostic Equivalence of the Skin Prick Test Tape vs. Conventional Skin PrickTest
A study testing Skin Prick Test and Skin Prick Test TAPE in people with Allergic Rhinitis and Allergic Asthma, run by Prof. Dr. Claus Bachert BVBA.
Trial summary
Testing of a new ready-to-use Tape in comparison to the currently used skin prick test for the diagnosis of allergies. Assessment of clinical equivalence of the SPT Tape for representative common inhalant allergens to conventional SPT in terms of wheal reaction positivity and overall safety. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis, Allergic Asthma, Allergic Conjunctivitis
- What is being tested?
- Skin Prick Test and Skin Prick Test TAPE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2019to 30 Jul 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will be included only, if
- they were informed about the nature, meaning, and scope of the study, and if they provided written consent to their participation
- they are at least 18 years of age,
- they have a history of allergic rhinitis due to grass and/or birch pollen, house dust mites, mugwort, cat and/or dog dander, and/or Alternaria since 2 years or more
Who cannot join
- Subjects may not be included, if
- they are impaired in understanding nature, meaning, and the scope of the study, or are incapable of giving written informed consent,
- they suffer from diseases, show other conditions, or take medications, which might impact the skin tests or might contradict the correct conduct and evaluation of the study. In particular this includes the following:
- acute allergy,
- history of systemic reactions or hypersensitivity to allergens, abuse of drugs or alcohol
- severe diseases,
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- impaired reactivity of the skin (e.g. hyperkeratosis, ichthyosis, urticaria factitia) and acute chronic eczema in the skin test areas, skin infections,
- pregnancy or nursing,
- treatment with β-blockers,
- treatment with antihistamines or systemic glucocorticoids during the last 4 weeks, with astemizol during the last 12 weeks,
- treatment with tricyclic antidepressants benzodiazepines, and neuroleptic drugs which may have histamine-antagonistic effects during the last 2 weeks,
- participation in any other medication study at the study time
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Bridging Study Investigating the Diagnostic Equivalence of the SPT Tape in Comparison With the Conventional SPT Using ALK SoluprickR Allergen Extracts in Patients With Inhalation Allergy
Testing of a new ready-to-use Tape in comparison to the currently used skin prick test for the diagnosis of allergies. Assessment of clinical equivalence of the SPT Tape for representative common inhalant allergens to conventional SPT in terms of wheal reaction positivity and overall safety. Tests are performed in patients who have a medical history of relevant allergic rhinitis to any of the tested allergens.
Read the detailed description
An open-label, single site bridging study. Subjects with a history of in-halation allergies will be tested in parallel with the SPT Tape and with the conventional SPT procedure using one forearm each.
In each patient, a panel of 8 allergens with the SPT Tape and with the conventional SPT is applied on the two forearms one time only.
The following Soluprick® allergens and control solutions will be evaluated:
Positive control, negative control, Phleum pratense, birch, Dermatophagoides pteronyssinus, D. farinae, dog dander, cat dander, mugwort, Alternaria sp. The allergens used for the SPT and the SPT Tape are identical Soluprick allergen solutions; allergens will be applied in the same location and order on both arms.
- Being tested
- Skin Prick Test, Skin Prick Test TAPE
- Medical subject headings
- Rhinitis, Allergic, Conjunctivitis, Allergic, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin Prick TestDiagnostic test
Skin Prick Testing with inhalant allergens
Skin Prick Test TAPEDiagnostic test
Skin Prick Testing with a Tape, integrating the allergens and needles
| Study group | Role | What they receive |
|---|---|---|
| Skin Prick Test TAPE | Active comparator | The Skin Prick Test Tape is an innovative sterile "all-in" drug carrying 8 allergens and 2 control solutions including prick needles in one Tape for easy use and standardization. Single use. Reading of wheal reactions after 15 minutes, facilitated by stripes with the allergen names. Receives: Diagnostic Test: Skin Prick Test TAPE |
| Skin Prick Test | Active comparator | The conventional SPT is the world-wide standard in allergy Type 1 diagnosis for inhalant and food allergens. Drops of allergens are applied to the forearm and, with the help of a lancet, brought into the skin. Reading of wheal reactions after 15 minutes. Receives: Diagnostic Test: Skin Prick Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wheal diameters
Maximal wheal diameter in millimeter
Measured: 15 min
Secondary outcomes (2)
Visual Analogue Scale on Comfort
Visual Analogue Scale from 0-10 cm from "not at all unpleasant" to "very unpleasant"
Measured: 30 min
Patient' s preference
Patients are asked to select the test they would prefer
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start1 Mar 2019 (estimated)
- Primary completion31 Mar 2019 (estimated)
- Study completion30 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison of conventional Skin Prick Test vs. Tape SPT
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Claus Bachert BVBA
- Responsible party
- Sponsor
- Investigators
- Martin Wagenmann, MD, Principal investigator, University pf Düsseldorf, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03820154
- Sponsor's protocol ID
- CBauchert
- Acronym
- SPTTapeD1
- Status last verified
- Jan 2019
- First submitted
- 23 Sep 2018
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bridging Study Investigating the Diagnostic Equivalence of the SPT Tape in Comparison With the Conventional SPT Using ALK SoluprickR Allergen Extracts in Patients With Inhalation Allergy
- ClinicalTrials.gov ID
- NCT03820154
- Acronym / sponsor ID
- SPTTapeD1 / CBauchert
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Prof. Dr. Claus Bachert BVBA
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 31 Mar 2019 (estimated)
- Study completion
- 30 Jul 2019 (estimated)
- First posted
- 29 Jan 2019 (actual)
- 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.
Testing of a new ready-to-use Tape in comparison to the currently used skin prick test for the diagnosis of allergies. Assessment of clinical equivalence of the SPT Tape for representative common inhalant allergens to conventional SPT in terms of wheal reaction positivity and overall safety. Tests are performed in patients who have a medical history of relevant allergic rhinitis to any of the tested allergens.
Detailed description
An open-label, single site bridging study. Subjects with a history of in-halation allergies will be tested in parallel with the SPT Tape and with the conventional SPT procedure using one forearm each.
In each patient, a panel of 8 allergens with the SPT Tape and with the conventional SPT is applied on the two forearms one time only.
The following Soluprick® allergens and control solutions will be evaluated:
Positive control, negative control, Phleum pratense, birch, Dermatophagoides pteronyssinus, D. farinae, dog dander, cat dander, mugwort, Alternaria sp. The allergens used for the SPT and the SPT Tape are identical Soluprick allergen solutions; allergens will be applied in the same location and order on both arms.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparison of conventional Skin Prick Test vs. Tape SPT
| Arm | Type | Receives |
|---|---|---|
| Skin Prick Test TAPE | Active comparator | Diagnostic Test: Skin Prick Test TAPEThe Skin Prick Test Tape is an innovative sterile "all-in" drug carrying 8 allergens and 2 control solutions including prick needles in one Tape for easy use and standardization. Single use. Reading of wheal reactions after 15 minutes, facilitated by stripes with the allergen names. |
| Skin Prick Test | Active comparator | Diagnostic Test: Skin Prick TestThe conventional SPT is the world-wide standard in allergy Type 1 diagnosis for inhalant and food allergens. Drops of allergens are applied to the forearm and, with the help of a lancet, brought into the skin. Reading of wheal reactions after 15 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects will be included only, if
Key exclusion criteria (12 listed)
- Subjects may not be included, if
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 |
|---|---|---|
| Skin Prick TestSkin Prick Testing with inhalant allergens | Diagnostic test | Skin Prick Test |
| Skin Prick Test TAPESkin Prick Testing with a Tape, integrating the allergens and needles | Diagnostic test | Skin Prick Test TAPE |
Primary outcome
Wheal diameters
Time frame: 15 min
Maximal wheal diameter in millimeter
2 secondary outcomes
Visual Analogue Scale on Comfort
Time frame: 30 min
Patient' s preference
Time frame: 30 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
- 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.
Martin Wagenmann, MD principal investigator
University pf Düsseldorf, Germany
Questions about this trial
What is this clinical trial studying?
A study testing Skin Prick Test and Skin Prick Test TAPE in people with Allergic Rhinitis and Allergic Asthma, run by Prof. Dr. Claus Bachert BVBA.
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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 29 Jan 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claus U Bachert, MD (+32473310902, claus.bachert@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wheal diameters (time frame: 15 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2019.