Patients With AERD Undergoing Aspirin DesensitizationNCT01666275
The Metabolomics of Anaphylaxis
An observational study of Patients With AERD Undergoing Aspirin Desensitization, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Metabolomics is the study of metabolic pathways and the unique biochemical molecules which result from the regulatory response to physiological stressors, disease processes, or drug therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Patients With AERD Undergoing Aspirin Desensitization
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 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, history of an allergic reaction to aspirin and referred for a clinically indicated outpatient or inpatient aspirin desensitization procedure for aspirin exacerbated respiratory disease (AERD)
Who may be able to join
- Patients ages 18-75 with a history of aspirin anaphylaxis or a history of hypersensitivity reaction to aspirin and referred for a clinically indicated outpatient or inpatient aspirin desensitization procedure for AERD.
Who cannot join
- Pregnancy/breastfeeding, possibility of poor compliance, unwilling to undergo aspirin desensitization.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital - Allergy Associates
Boston, Massachusetts, 02114
About this study
Metabolomics is the study of metabolic pathways and the unique biochemical molecules which result from the regulatory response to physiological stressors, disease processes, or drug therapy. By measuring changes in metabolite concentrations, the range of biochemical effects and therapeutic intervention can be determined.
Aspirin exacerbated respiratory disease (AERD) is a chronic inflammatory disease characterized by chronic rhinosinusitis, nasal polyposis, asthma, and airway reactivity to aspirin and/or other nonsteroidal anti-inflammatory drugs (NSAIDs). This reaction to aspirin during challenge/desensitization is equivalent to an allergic drug reaction however we are able to evaluate these specific reactions in a controlled, clinical environment. This population of patients undergoing aspirin desensitization is ideal for studying metabolomics as serial blood sampling can be performed in patients before, during a reaction, and after aspirin desensitization, thereby allowing each patient to serve as his or her own biological control. The investigator hopes that this study of metabolomics will allow for better methods of identifying anaphylaxis in the future.
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 |
|---|---|---|
| Aspirin desensitization | This group of patients has AERD (aspirin exacerbated respiratory disease) and is undergoing aspirin desensitization. |
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 Baseline to 1 week post-desensitization
Metabolic profiling will be done on specific blood serum metabolites including lipid mediators, amino acids, and leukotrienes.
Measured: before start of aspirin desensitization, 2 hours into desensitization, at time of reaction(s) - an expected average of 6 hours into desensitization, 1 week post-desensitization
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 startMar 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 Patients With AERD Undergoing Aspirin DesensitizationStudies 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
- NCT01666275
- Sponsor's protocol ID
- 2012P000448
- 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
- ClinicalTrials.gov ID
- NCT01666275
- Acronym / sponsor ID
- 2012P000448
- 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
- Mar 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.
Metabolomics is the study of metabolic pathways and the unique biochemical molecules which result from the regulatory response to physiological stressors, disease processes, or drug therapy. By measuring changes in metabolite concentrations, the range of biochemical effects and therapeutic intervention can be determined.
Aspirin exacerbated respiratory disease (AERD) is a chronic inflammatory disease characterized by chronic rhinosinusitis, nasal polyposis, asthma, and airway reactivity to aspirin and/or other nonsteroidal anti-inflammatory drugs (NSAIDs). This reaction to aspirin during challenge/desensitization is equivalent to an allergic drug reaction however we are able to evaluate these specific reactions in a controlled, clinical environment. This population of patients undergoing aspirin desensitization is ideal for studying metabolomics as serial blood sampling can be performed in patients before, during a reaction, and after aspirin desensitization, thereby allowing each patient to serve as his or her own biological control. The investigator hopes that this study of metabolomics will allow for better methods of identifying anaphylaxis in the future.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aspirin desensitization | – | –This group of patients has AERD (aspirin exacerbated respiratory disease) and is undergoing aspirin desensitization. |
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, history of an allergic reaction to aspirin and referred for a clinically indicated outpatient or inpatient aspirin desensitization procedure for aspirin exacerbated respiratory disease (AERD)
Key inclusion criteria (1 listed)
- Patients ages 18-75 with a history of aspirin anaphylaxis or a history of hypersensitivity reaction to aspirin and referred for a clinically indicated outpatient or inpatient aspirin desensitization procedure for AERD.
Key exclusion criteria (1 listed)
- Pregnancy/breastfeeding, possibility of poor compliance, unwilling to undergo aspirin desensitization.
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 Baseline to 1 week post-desensitization
Time frame: before start of aspirin desensitization, 2 hours into desensitization, at time of reaction(s) - an expected average of 6 hours into desensitization, 1 week post-desensitization
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 Patients With AERD Undergoing Aspirin Desensitization, 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 1 inclusion and 1 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 Baseline to 1 week post-desensitization (time frame: before start of aspirin desensitization, 2 hours into desensitization, at time of reaction(s) - an expected average of 6 hours into desensitization, 1 week post-desensitization). 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.