AllergiesPhase 2NCT00719511
Study of Specific Allergen Immunotherapy in Grass Pollen Allergic Subjects by Epicutaneous Allergen Administration
A Phase 2 study testing Purified allergen dose 1 integrated in a Patch system, Purified allergen dose 2 integrated in a Patch system and Purified allergen dose 3 integrated in a Patch system in people with Allergies, run by University of Zurich at 1 site in Switzerland.
Trial summary
Evaluation of patch as specific immunotherapy in allergic patients Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergies
- What is being tested?
- Purified allergen dose 1 integrated in a Patch system, Purified allergen dose 2 integrated in a Patch system and Purified allergen dose 3 integrated in a Patch system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2008to Dec 2009
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- History of grass pollen allergic rhinitis
- Male and female between 18 years to 65 years
- Positive skin-prick test to grass pollen
- Positive conjunctival provocation test
Who cannot join
- Eczematous skin lesions on the upper arms
- Perennial allergic rhinitis
- Symptoms of infectious disease with rhinitis in between the last 2 weeks
- Surgical intervention in between the last 30 days
- Pregnancy or nursing
- History of HIV or AIDS
Show all 25Show fewer
- History of mastocytosis (cutaneous or systemic)
- History of significant cardiovascular disease
- Hypertension (blood pressure > 160 / 95)
- History of significant pulmonary, renal and/or hepatic disease
- History of significant hematological disorder
- Moderate or severe asthma
- History of malignancy
- History of neurological or psychiatric disease
- History of autoimmune disease
- Antihistamines with longed half-lives in the last week
- Systemic or topical steroids for 5 days
- Active infectious disease
- Contraindicated medications:
- immunosuppressive agents
- Betablockers
- ACE-inhibitors, AT 2 Antagonists
- tricyclic antidepressants
- daily use of Beta-agonists or steroid inhalers
- Participation in another clinical trial /study at the moment or within the last 60 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Center Phase I/IIa, Placebo Controlled, Randomized, Double-blind, Dose-response Study to Assess the Optimal Dose as Well as Clinical Efficacy and Safety of a Novel Method of Specific Allergen Immunotherapy in Grass Pollen Allergic Subjects by Epicutaneous Allergen Administration
Evaluation of patch as specific immunotherapy in allergic patients
- Conditions
- Allergies
- Being tested
- Purified allergen dose 1 integrated in a Patch system, Purified allergen dose 2 integrated in a Patch system, Purified allergen dose 3 integrated in a Patch system, Purified allergen integrated in a Patch system
- Keywords
- Rhinoconjunctivitis, Allergic
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Purified allergen dose 1 integrated in a Patch systemDrug
Epicutaneous application of a patch
Purified allergen dose 2 integrated in a Patch systemDrug
Epicutaneous application of a patch
Purified allergen dose 3 integrated in a Patch systemDrug
Epicutaneous application of a patch
Purified allergen integrated in a Patch systemDrug
Epicutaneous application of a patch
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patch allergen dose 1 Receives: Drug: Purified allergen dose 1 integrated in a Patch system |
| 2 | Experimental | Patch allergen dose 2 Receives: Drug: Purified allergen dose 2 integrated in a Patch system |
| 3 | Experimental | Patch allergen dose 3 Receives: Drug: Purified allergen dose 3 integrated in a Patch system |
| 4 | Experimental | Placebo Receives: Drug: Purified allergen integrated in a Patch system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the efficacy of the placebo with that of three different test doses of the epicutaneous pollen allergen administration evaluated by visual analog scales after the treatment
Measured: 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2008 (estimated)
- Study startFeb 2008
- Primary completionNov 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergiesStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Investigators
- 01 Studienregister MasterAdmins, Study director, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00719511
- Sponsor's protocol ID
- ZU-SkinSIT-002
- Status last verified
- Feb 2011
- First submitted
- 17 Jul 2008
- Last updated
- 17 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center Phase I/IIa, Placebo Controlled, Randomized, Double-blind, Dose-response Study to Assess the Optimal Dose as Well as Clinical Efficacy and Safety of a Novel Method of Specific Allergen Immunotherapy in Grass Pollen Allergic Subjects by Epicutaneous Allergen Administration
- ClinicalTrials.gov ID
- NCT00719511
- Acronym / sponsor ID
- ZU-SkinSIT-002
- Conditions
- Allergies
- Keywords
- Rhinoconjunctivitis, Allergic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 21 Jul 2008 (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.
Evaluation of patch as specific immunotherapy in allergic patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Purified allergen dose 1 integrated in a Patch systemPatch allergen dose 1 |
| 2 | Experimental | Drug: Purified allergen dose 2 integrated in a Patch systemPatch allergen dose 2 |
| 3 | Experimental | Drug: Purified allergen dose 3 integrated in a Patch systemPatch allergen dose 3 |
| 4 | Experimental | Drug: Purified allergen integrated in a Patch systemPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent
- History of grass pollen allergic rhinitis
- Male and female between 18 years to 65 years
- Positive skin-prick test to grass pollen
- Positive conjunctival provocation test
Key exclusion criteria (25 listed)
- Eczematous skin lesions on the upper arms
- Perennial allergic rhinitis
- Symptoms of infectious disease with rhinitis in between the last 2 weeks
- Surgical intervention in between the last 30 days
- Pregnancy or nursing
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 |
|---|---|---|
| Purified allergen dose 1 integrated in a Patch systemEpicutaneous application of a patch | Drug | 1 |
| Purified allergen dose 2 integrated in a Patch systemEpicutaneous application of a patch | Drug | 2 |
| Purified allergen dose 3 integrated in a Patch systemEpicutaneous application of a patch | Drug | 3 |
| Purified allergen integrated in a Patch systemEpicutaneous application of a patch | Drug | 4 |
Primary outcome
Comparison of the efficacy of the placebo with that of three different test doses of the epicutaneous pollen allergen administration evaluated by visual analog scales after the treatment
Time frame: 2010
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 17 Feb 2011.
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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.
01 Studienregister MasterAdmins study director
UniversitaetsSpital Zuerich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Purified allergen dose 1 integrated in a Patch system, Purified allergen dose 2 integrated in a Patch system and Purified allergen dose 3 integrated in a Patch system in people with Allergies, run by University of Zurich at 1 site in Switzerland.
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 5 inclusion and 25 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 17 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
Comparison of the efficacy of the placebo with that of three different test doses of the epicutaneous pollen allergen administration evaluated by visual analog scales after the treatment (time frame: 2010). 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 17 Feb 2011.