Allergy Dermatophagoides PteronyssinusPhase 2NCT01821716
Biological Standardization of Dermatophagoides Pteronyssinus Allergen Extract
A Phase 2 study testing Prick test Dermatophagoides pteronyssinus allergen extract in people with Allergy Dermatophagoides Pteronyssinus and Allergic Rhinitis, run by Laboratorios Leti, S.L. at 2 sites in Spain.
Trial summary
The objective of this study is to determine the biologic activity of a Dermatophagoides pteronyssinus allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Allergy Dermatophagoides Pteronyssinus, Allergic Rhinitis, Allergic Asthma
- What is being tested?
- Prick test Dermatophagoides pteronyssinus allergen extract
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesSpain
- Study dates
- Mar 2013to Jan 2014
- Phase
- Phase 2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject has provided written informed consent, appropriately signed and dated by the subject (or legal representative, if applicable).
- Subject can be male or female of any race and ethnic group.
- Age > and =18 years and < and =60 years at the study inclusion day.
- Medical history of allergy with respiratory symptoms (rhinitis and /or rhinoconjunctivitis and/or asthma) to Dermatophagoides pteronyssinus.
- Positive skin prick test with a standardized commercially available preparation of Dermatophagoides pteronyssinus allergen extract. The skin prick test will be considered positive if the test results in a wheal major diameter of at least 3 mm or an area at least 7 mm2. Positive skin prick test results are valid if performed within one year prior to the inclusion of the subject in the study
- A positive test for specific IgE to Dermatophagoides pteronyssinus (CAP-RAST major or equal to 2). IgE results are valid if performed within one year prior to the inclusion of the subject in the study.
Who cannot join
- Immunotherapy in the past 5 years with a Dermatophagoides pteronyssinus allergen extract or other mites allergen extracts known to interfere with the allergen to be tested, due to a high degree of cross-reactivity.
- Use of drugs that may interfere with the skin reactions (e.g., antihistamines). See Appendix 1 of the protocol.
- Treatment with any of the following medications: oral tricyclic or tetracyclic antidepressants or IMAOs, beta-blockers, chronic use of corticosteroids or use of oral or parenteral corticosteroids in repeated and intermittent patterns (10 mg/daily of prednisone or equivalent).
- Women who are pregnant or period of breastfeeding and women with a pregnancy test positive during the visit 2, prior to the prick test.
- Dermographism affecting the skin area at the test site at either study visit.
- Atopic dermatitis affecting the skin area at the test site at either study visit.
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- Urticaria affecting the skin area at the test site at either study visit.
- Diseases of the immune system relevant clinically, both autoimmune and immunodeficiencies.
- Serious diseases not controlled that may increase the risk for the safety of the subjects involved in this study, including, but not limited to the following: heart failure, uncontrolled or severe respiratory diseases,endocrine diseases, clinically relevant kidney or liver diseases or hematological diseases.
- Participation in any other clinical trial within 30 days (or 5 times the biological half-life of the research of the study product, whichever is longer) prior to the inclusion of the subject in this clinical trial.
- Patients with diseases or conditions that limit the use of adrenaline (heart disease, severe hypertension...)
- Severe psychiatric, psychological or neurological disorders
- Abuse of alcohol, drugs or medicines in the previous year.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Complexo Hospitalario Universitario A Coruña (Hospital Abente y Lago)
A Coruña, 15001
Hospital de Denia (Marina Salud)
Denia, Alicante, 03700
About this study
Official title: Biological Standardization of Dermatophagoides Pteronyssinus Allergen Extract to Determine the Biological Activity in HEP Units.
The objective of this study is to determine the biologic activity of a Dermatophagoides pteronyssinus allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).
Read the detailed description
This is an open, unblinded and non-randomized biological assay. The study design is a slight modification of the recommendations proposed by the Nordic Guidelines.
Three concentrations of Dermatophagoides pteronyssinus allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm.
- Being tested
- Prick test Dermatophagoides pteronyssinus allergen extract
- Keywords
- standardization, skin prick test, inmunotherapy
- Medical subject headings
- Dust Mite Allergy, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prick test Dermatophagoides pteronyssinus allergen extractBiological
This is an open, unblinded and non randomized biological as proposed by the Nordic Guidelines.
Three concentrations of Dermatophagoides pteronyssinus allergen extract, together with a positive and negative control, using 10 mg/ml histamine dichloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm. This test will be referred to as the Titrated Skin Prick test.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Three concentrations of Dermatophagoides pteronyssinus allergen extract (10, 1, 0.1 mg/ml)
Positive control (10 mg/ml histamine dihydrochloride)
Negative control (glycerinated phenol saline solution) Receives: Biological: Prick test Dermatophagoides pteronyssinus allergen extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase.
Measured: Test sites should be inspected and recorded 15-20 min after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergy Dermatophagoides PteronyssinusStudies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Leti, S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821716
- Sponsor's protocol ID
- 101-PR-PRI-196
- Status last verified
- Feb 2018
- First submitted
- 27 Mar 2013
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Standardization of Dermatophagoides Pteronyssinus Allergen Extract to Determine the Biological Activity in HEP Units.
- ClinicalTrials.gov ID
- NCT01821716
- Acronym / sponsor ID
- 101-PR-PRI-196
- Keywords
- standardization, skin prick test, inmunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Laboratorios Leti, S.L.Industry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 1 Apr 2013 (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 objective of this study is to determine the biologic activity of a Dermatophagoides pteronyssinus allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).
Detailed description
This is an open, unblinded and non-randomized biological assay. The study design is a slight modification of the recommendations proposed by the Nordic Guidelines.
Three concentrations of Dermatophagoides pteronyssinus allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Prick test Dermatophagoides pteronyssinus allergen extractThree concentrations of Dermatophagoides pteronyssinus allergen extract (10, 1, 0.1 mg/ml) Positive control (10 mg/ml histamine dihydrochloride) Negative control (glycerinated phenol saline solution) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subject has provided written informed consent, appropriately signed and dated by the subject (or legal representative, if applicable).
- Subject can be male or female of any race and ethnic group.
- Age > and =18 years and < and =60 years at the study inclusion day.
- Medical history of allergy with respiratory symptoms (rhinitis and /or rhinoconjunctivitis and/or asthma) to Dermatophagoides pteronyssinus.
- Positive skin prick test with a standardized commercially available preparation of Dermatophagoides pteronyssinus allergen extract. The skin prick test will be considered positive if the test results in a wheal major diameter of at least 3 mm or an area at least 7 mm2. Positive skin prick test results are valid if performed within one year prior to the inclusion of the subject in the study
Key exclusion criteria (13 listed)
- Immunotherapy in the past 5 years with a Dermatophagoides pteronyssinus allergen extract or other mites allergen extracts known to interfere with the allergen to be tested, due to a high degree of cross-reactivity.
- Use of drugs that may interfere with the skin reactions (e.g., antihistamines). See Appendix 1 of the protocol.
- Treatment with any of the following medications: oral tricyclic or tetracyclic antidepressants or IMAOs, beta-blockers, chronic use of corticosteroids or use of oral or parenteral corticosteroids in repeated and intermittent patterns (10 mg/daily of prednisone or equivalent).
- Women who are pregnant or period of breastfeeding and women with a pregnancy test positive during the visit 2, prior to the prick test.
- Dermographism affecting the skin area at the test site at either study visit.
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 |
|---|---|---|
| Prick test Dermatophagoides pteronyssinus allergen extractThis is an open, unblinded and non randomized biological as proposed by the Nordic Guidelines. Three concentrations of Dermatophagoides pteronyssinus allergen extract, together with a positive and negative control, using 10 mg/ml histamine dichloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm. This test will be referred to as the Titrated Skin Prick test. | Biological | 1 |
Primary outcome
Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase.
Time frame: Test sites should be inspected and recorded 15-20 min after application
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 23 Feb 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prick test Dermatophagoides pteronyssinus allergen extract in people with Allergy Dermatophagoides Pteronyssinus and Allergic Rhinitis, run by Laboratorios Leti, S.L. at 2 sites in Spain.
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 6 inclusion and 13 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 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase. (time frame: Test sites should be inspected and recorded 15-20 min after application). 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 23 Feb 2018.