Allergy to MoldNCT01494194
Study to Evaluate the Potential of Air Structuring Protein to Elicit Allergic Reactions in Mold Sensitized People
A study testing Air Structuring Protein in people with Allergy to Mold, run by Unilever SEAC at 1 site in United Kingdom.
Trial summary
Air Structuring Protein (ASP) is a small protein derived from a fungus which is already widely used to produce enzymes that are added to foods. ASP has the possibility of stabilising the air phase of ice-cream and therefore there is interest in ASP as a potential ice-cream ingredient. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergy to Mold
- What is being tested?
- Air Structuring Protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 252 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2011to Jul 2012
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females aged 18-60 years.
- Mould sensitised subjects diagnosed according to the EAACI/Ga2len guidelines.
- Written informed consent from the subject.
- Normally active and otherwise judged to be in good health on the basis of medical history and screening assessment.
- No allergic symptoms on the day of investigation.
Who cannot join
- Pregnancy or lactation.
- Failure to comply with the protocol.
- Medication that may interfere with wheal formation in the skin or response to DBPCFC
- Participation in another clinical study involving a SPT within 30 days prior to Visit 1 or DBPCFC within 30 days prior to DBPCFC.
- Current skin disease of any type (eczema, acne, dermatitis, etc.) on the test site(s).
- Subjects with a condition the Investigator believes would interfere with the evaluation of the subject, including proceeding to DBPCFC, or may put the subject at undue risk, e.g., a history of anaphylactic reactions and history of reactions to any component of the DBPCFC matrix other than ASP.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
National Heart and Lung Institute, MRC & Asthma UK Centre in Allergic Mechanisms of Asthma, Centre for Respiratory Infection, Imperial College London
London, W2 1PG
About this study
Official title: Evaluation of the Potential of Air Structuring Protein, a Novel Protein Preparation Derived From Trichoderma Reesei, to Elicit Allergic Reactions in Mold Sensitized People
Air Structuring Protein (ASP) is a small protein derived from a fungus which is already widely used to produce enzymes that are added to foods. ASP has the possibility of stabilising the air phase of ice-cream and therefore there is interest in ASP as a potential ice-cream ingredient.
Toxicological tests have also been carried out to further confirm the safety of the material and no evidence of genotoxicity or acute toxicity has been observed in any of the tests.
Read more
As part of the safety evaluation of a new protein for use in foods, the potential allergenicity is also investigated and Unilever is sponsoring a study to evaluate this aspect of ASP. This study will investigate:
- Whether ASP has the potential to elicit a positive skin prick test (SPT) in a population of participants with proven sensitivity to mould.
- Whether ASP is responsible for any positive SPT reactions, should they occur.
- And if any positive SPT reactions to ASP occur, whether such reactions are clinically relevant with respect to food allergy.
The study is divided in three stages. In Stage 1 and Stage 2, the SPT is "open label," which means that both the participant and the study doctor will know which materials are being tested.
In Stage 3, the food challenge has a "crossover" design, meaning that participants will take one of the products (ASP or placebo [food containing no ASP]) during the first half of the study and the other treatment during the second half. The order of ASP and placebo will be decided randomly, like tossing a coin. To make the comparison between ASP and placebo as fair as possible, the food challenge is "double blinded." This means that neither the participant nor the study doctor will know which kind of products (ASP or placebo) the participant is taking.
This is a multi centre study which is taking place in the UK.
- Conditions
- Allergy to Mold
- Being tested
- Air Structuring Protein, Placebo sorbet
- Keywords
- Mold sensitized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air Structuring ProteinOther
A novel food protein preparation
Placebo sorbetOther
Placebo sorbet for double blind placebo controlled food challenge
| Study group | Role | What they receive |
|---|---|---|
| placebo for food challenge | Placebo comparator | Not described Receives: Other: Placebo sorbet |
| ASP Skin prick solution | Experimental | Not described Receives: Other: Air Structuring Protein |
| ASP sorbet | Experimental | Not described Receives: Other: Air Structuring Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive skin prick test response to test material
The number and size of positive SPTs will be recorded together with data of concomitant allergies and the minimum eliciting concentration (SPT-min) in the skin.
Measured: 15 minutes after application
Secondary outcomes (1)
The number of positive Double Blind Placebo Controlled Food Challenge reactions in those with positive skin prick test result
The number of positive DBPCFC reactions will be recorded together with pre and post challenge blood pressure, pulse rate, peak expiratory flow (PEF) and forced expiratory volume (FEV1), data of concomitant allergies, any symptoms elicited including any late onset reactions, timing of symptoms and the minimum eliciting dose of ASP.
Measured: 2 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergy to MoldStudies 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever SEAC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01494194
- Sponsor's protocol ID
- KQC100140
- Status last verified
- Jun 2015
- First submitted
- 12 Dec 2011
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Potential of Air Structuring Protein, a Novel Protein Preparation Derived From Trichoderma Reesei, to Elicit Allergic Reactions in Mold Sensitized People
- ClinicalTrials.gov ID
- NCT01494194
- Acronym / sponsor ID
- KQC100140
- Conditions
- Allergy to Mold
- Keywords
- Mold sensitized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Unilever SEACIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 16 Dec 2011 (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.
Air Structuring Protein (ASP) is a small protein derived from a fungus which is already widely used to produce enzymes that are added to foods. ASP has the possibility of stabilising the air phase of ice-cream and therefore there is interest in ASP as a potential ice-cream ingredient.
Toxicological tests have also been carried out to further confirm the safety of the material and no evidence of genotoxicity or acute toxicity has been observed in any of the tests.
As part of the safety evaluation of a new protein for use in foods, the potential allergenicity is also investigated and Unilever is sponsoring a study to evaluate this aspect of ASP. This study will investigate:
- Whether ASP has the potential to elicit a positive skin prick test (SPT) in a population of participants with proven sensitivity to mould.
- Whether ASP is responsible for any positive SPT reactions, should they occur.
- And if any positive SPT reactions to ASP occur, whether such reactions are clinically relevant with respect to food allergy.
The study is divided in three stages. In Stage 1 and Stage 2, the SPT is "open label," which means that both the participant and the study doctor will know which materials are being tested.
In Stage 3, the food challenge has a "crossover" design, meaning that participants will take one of the products (ASP or placebo [food containing no ASP]) during the first half of the study and the other treatment during the second half. The order of ASP and placebo will be decided randomly, like tossing a coin. To make the comparison between ASP and placebo as fair as possible, the food challenge is "double blinded." This means that neither the participant nor the study doctor will know which kind of products (ASP or placebo) the participant is taking.
This is a multi centre study which is taking place in the UK.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo for food challenge | Placebo comparator | Other: Placebo sorbet |
| ASP Skin prick solution | Experimental | Other: Air Structuring Protein |
| ASP sorbet | Experimental | Other: Air Structuring Protein |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males and females aged 18-60 years.
- Mould sensitised subjects diagnosed according to the EAACI/Ga2len guidelines.
- Written informed consent from the subject.
- Normally active and otherwise judged to be in good health on the basis of medical history and screening assessment.
- No allergic symptoms on the day of investigation.
Key exclusion criteria (6 listed)
- Pregnancy or lactation.
- Failure to comply with the protocol.
- Medication that may interfere with wheal formation in the skin or response to DBPCFC
- Participation in another clinical study involving a SPT within 30 days prior to Visit 1 or DBPCFC within 30 days prior to DBPCFC.
- Current skin disease of any type (eczema, acne, dermatitis, etc.) on the test site(s).
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 |
|---|---|---|
| Air Structuring ProteinA novel food protein preparation | Other | ASP Skin prick solution, ASP sorbet |
| Placebo sorbetPlacebo sorbet for double blind placebo controlled food challenge | Other | placebo for food challenge |
Primary outcome
Positive skin prick test response to test material
Time frame: 15 minutes after application
The number and size of positive SPTs will be recorded together with data of concomitant allergies and the minimum eliciting concentration (SPT-min) in the skin.
1 secondary outcome
The number of positive Double Blind Placebo Controlled Food Challenge reactions in those with positive skin prick test result
Time frame: 2 hours after administration
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 8 Jun 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air Structuring Protein in people with Allergy to Mold, run by Unilever SEAC at 1 site in United Kingdom.
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 6 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 8 Jun 2015. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Positive skin prick test response to test material (time frame: 15 minutes 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 8 Jun 2015.