Anaphylaxis as a Result of Allergen or Venom ImmunotherapyNCT01666288
The Metabolomics of Anaphylaxis to Immunotherapy
An observational study of Anaphylaxis as a Result of Allergen or Venom Immunotherapy, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Anaphylaxis is defined as a serious allergic reaction mediated by IgE that is often difficult to diagnose due to the wide heterogeneity of clinical manifestations. The inciting agent is often difficult to pinpoint and may include food, environmental allergens in patients undergoing allergen immunotherapy, insect… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anaphylaxis as a Result of Allergen or Venom Immunotherapy
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to 14 Aug 2018
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients ages 18-75, undergoing routine outpatient subcutaneous environmental allergen and/or venom immunotherapy
Who may be able to join
- Males and females age 18-75 who are receiving routine outpatient subcutaneous allergen and/or venom immunotherapy and who meet the World Allergy Organization (WAO) criteria for anaphylaxis (below):
- Has at least ONE of the following three criteria:
- Acute onset of an illness with involvement of the skin, mucosal tissue, or both (eg, generalized urticaria, itching or flushing, swollen lips-tongue-uvula)
- AND AT LEAST ONE OF THE FOLLOWING:
- Respiratory compromise (eg, dyspnea, wheeze-bronchospasm, stridor, reduced PEF, hypoxemia) B) Reduced blood pressure or associated symptoms of end-organ dysfunction (eg. Hypotonia, collapse, syncope, incontinence)
- OR
Show all 13Show fewer
- Two or more of the following that occur rapidly after exposure to a known allergen for that patient
- Involvement of the skin-mucosal tissue (eg, generalized urticaria, itch-flush, swollen lips-tongue-uvula)
- Respiratory compromise (eg, dyspnea, wheeze-bronchospasm, stridor, reduced PEF, hypoxemia)
- Reduced blood pressure or associated symptoms (eg, hypotonia, collapse,, syncope, incontinence)
- Persistent gastrointestinal symptoms (eg, crampy abdominal pain, vomiting)
- OR
- Reduced blood pressure after exposure to known allergen for that patient with systolic blood pressure of less than 90 mm Hg or greater than 30% decrease from that person's baseline
Who cannot join
- Pregnancy/breastfeeding or possibility of poor compliance to subcutaneous allergen or venom immunotherapy.
- Does not meet the WAO criteria for anaphylaxis (above)
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital - Allergy Associates
Boston, Massachusetts, 02114
About this study
Anaphylaxis is defined as a serious allergic reaction mediated by IgE that is often difficult to diagnose due to the wide heterogeneity of clinical manifestations. The inciting agent is often difficult to pinpoint and may include food, environmental allergens in patients undergoing allergen immunotherapy, insect stings, and medications. Evidence of allergy by demonstration of a positive skin test to the inciting agent, is helpful only if skin testing is available. The only diagnostic modality that is useful in the diagnosis of anaphylaxis when IgE skin testing is not available and the inciting agent is unknown, is an elevated serum tryptase level. However, a diagnosis of anaphylaxis can be made without a tryptase level or if the tryptase level is normal. A simple, non-invasive test for patients with anaphylaxis is not currently available and would be helpful to diagnose and to guide further management options.
Patients who develop anaphylaxis to environmental allergens or venoms during routine outpatient subcutaneous allergen or venom immunotherapy are an ideal population to study as we are able to evaluate these specific reactions in a controlled, clinical environment. Although anaphylaxis is uncommon, the incidence has been estimated to vary between 0.01 and 4 percent of all allergy injections. Subcutaneous allergen or venom immunotherapies are a well established form of therapy for patients with allergic rhinitis, allergic asthma, or a confirmed sensitivity to stinging insects. Serial blood sampling can be performed in this group of patients during a reaction and at baseline one week after a reaction, thereby allowing each patient to serve as his or her own biological control.
Read more
Metabolomics is the study of metabolic pathways and the unique biochemical molecules which result from the regulatory response to physiological stressors, disease processes, drug therapy, or allergen or venom immunotherapy. By measuring changes in metabolite concentrations, the range of biochemical effects and therapeutic intervention can be determined.
The investigator plans to use metabolic profiling of blood samples collected at the time of anaphylaxis and one week after, to see if a simple, non-invasive test for patients with anaphylaxis could be developed.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IT Anaphylaxis | Blood samples will be taken from patient that develop anaphylaxis to routine outpatient allergen or venom immunotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in metabolic profile of blood serum metabolites from time of allergen/ venom immunotherapy reaction to one week post-reaction
Metabolic profiling will be done on specific blood serum metabolites including lipid mediators, amino acids, and leukotrienes
Measured: time of reaction to allergen or venom immunotherapy, one week post-reaction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2017 (estimated)
- Study completion14 Aug 2018
Why it stopped: We are closing the study because of lack of enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anaphylaxis as a Result of Allergen or Venom ImmunotherapyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleena Banerji, Massachusetts General Hospital
- Investigators
- Aleena S Banerji, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666288
- Sponsor's protocol ID
- 2012P000683
- Status last verified
- Mar 2019
- First submitted
- 7 Aug 2012
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Metabolomics of Anaphylaxis to Immunotherapy
- ClinicalTrials.gov ID
- NCT01666288
- Acronym / sponsor ID
- 2012P000683
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: We are closing the study because of lack of enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2017 (estimated)
- Study completion
- 14 Aug 2018 (actual)
- First posted
- 16 Aug 2012 (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.
Anaphylaxis is defined as a serious allergic reaction mediated by IgE that is often difficult to diagnose due to the wide heterogeneity of clinical manifestations. The inciting agent is often difficult to pinpoint and may include food, environmental allergens in patients undergoing allergen immunotherapy, insect stings, and medications. Evidence of allergy by demonstration of a positive skin test to the inciting agent, is helpful only if skin testing is available. The only diagnostic modality that is useful in the diagnosis of anaphylaxis when IgE skin testing is not available and the inciting agent is unknown, is an elevated serum tryptase level. However, a diagnosis of anaphylaxis can be made without a tryptase level or if the tryptase level is normal. A simple, non-invasive test for patients with anaphylaxis is not currently available and would be helpful to diagnose and to guide further management options.
Patients who develop anaphylaxis to environmental allergens or venoms during routine outpatient subcutaneous allergen or venom immunotherapy are an ideal population to study as we are able to evaluate these specific reactions in a controlled, clinical environment. Although anaphylaxis is uncommon, the incidence has been estimated to vary between 0.01 and 4 percent of all allergy injections. Subcutaneous allergen or venom immunotherapies are a well established form of therapy for patients with allergic rhinitis, allergic asthma, or a confirmed sensitivity to stinging insects. Serial blood sampling can be performed in this group of patients during a reaction and at baseline one week after a reaction, thereby allowing each patient to serve as his or her own biological control.
Metabolomics is the study of metabolic pathways and the unique biochemical molecules which result from the regulatory response to physiological stressors, disease processes, drug therapy, or allergen or venom immunotherapy. By measuring changes in metabolite concentrations, the range of biochemical effects and therapeutic intervention can be determined.
The investigator plans to use metabolic profiling of blood samples collected at the time of anaphylaxis and one week after, to see if a simple, non-invasive test for patients with anaphylaxis could be developed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IT Anaphylaxis | – | –Blood samples will be taken from patient that develop anaphylaxis to routine outpatient allergen or venom immunotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients ages 18-75, undergoing routine outpatient subcutaneous environmental allergen and/or venom immunotherapy
Key inclusion criteria (13 listed)
- Males and females age 18-75 who are receiving routine outpatient subcutaneous allergen and/or venom immunotherapy and who meet the World Allergy Organization (WAO) criteria for anaphylaxis (below):
- Acute onset of an illness with involvement of the skin, mucosal tissue, or both (eg, generalized urticaria, itching or flushing, swollen lips-tongue-uvula)
- OR
- Two or more of the following that occur rapidly after exposure to a known allergen for that patient
- OR
Key exclusion criteria (2 listed)
- Pregnancy/breastfeeding or possibility of poor compliance to subcutaneous allergen or venom immunotherapy.
- Does not meet the WAO criteria for anaphylaxis (above)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in metabolic profile of blood serum metabolites from time of allergen/ venom immunotherapy reaction to one week post-reaction
Time frame: time of reaction to allergen or venom immunotherapy, one week post-reaction
Metabolic profiling will be done on specific blood serum metabolites including lipid mediators, amino acids, and leukotrienes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
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.
Aleena S Banerji, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anaphylaxis as a Result of Allergen or Venom Immunotherapy, run by Massachusetts General Hospital at 1 site in United States.
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 13 inclusion and 2 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: withdrawn, as of the sponsor's last update on 7 Mar 2019. 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 States. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in metabolic profile of blood serum metabolites from time of allergen/ venom immunotherapy reaction to one week post-reaction (time frame: time of reaction to allergen or venom immunotherapy, one week post-reaction). 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 7 Mar 2019.