Asthma, Aspirin-InducedNCT02824523
Role of Inflammatory Mediators in AERD
An observational study of Asthma, Aspirin-Induced, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The purpose of this research study is to learn new information about the underlying cause of aspirin-exacerbated respiratory disease (AERD) and the benefit of high-dose aspirin therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma, Aspirin-Induced
- What is being tested?
- aspirin
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 1 May 2021
- 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 with aspirin-exacerbated respiratory disease who are undergoing aspirin desensitization and starting high-dose aspirin therapy
Who may be able to join
- History of asthma
- History of nasal polyposis
- History of at least one clinical reaction to oral aspirin or other nonselective COX inhibitor with features of both lower (cough, chest tightness, wheezing, dyspnea) and upper (rhinorrhea, sneezing, nasal obstruction, conjunctival itching and discharge) airway involvement
- Stable asthma (post-bronchodilator FEV1 of ≥70%, no use of oral or systemic steroids for at least 1 month, and no hospitalizations or emergency room visits for asthma for the prior 6 months) at the time of entry into the study
- Currently taking montelukast as part of standard asthma treatment for at least 4 weeks before the V1 visit
Who cannot join
- Pregnancy or current breastfeeding
- History of bleeding diathesis or use of anticoagulant or antiplatelet drugs
- History of thrombocytopenia < 50 x 10^9/L
- Hypersensitivity to montelukast
- Peptic ulcer disease
- Unstable asthma (post-bronchodilator FEV1 of less than 70%, use of oral or systemic steroids for at least 1 month prior to visit 1, or hospitalizations or emergency room visits for asthma for the prior 6 months)
Show all 9Show fewer
- Use of zileuton (which can mask symptoms of aspirin-induced reaction) within 1 month prior to the V1 visit
- Age under 18 or over 75 years
- Current smoking
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Role of PDG2 in the Aspirin-Induced Reactions and in the Treatment of Aspirin-Exacerbated Respiratory Disease
The purpose of this research study is to learn new information about the underlying cause of aspirin-exacerbated respiratory disease (AERD) and the benefit of high-dose aspirin therapy. AERD is a disease that involves asthma, recurring nasal polyps, and respiratory reactions to aspirin and other nonsteroidal anti-inflammatory drugs. This study will be conducted on individuals with AERD who are referred to the Brigham and Women's Hospital AERD Center for clinical evaluation and potential aspirin desensitization. Desensitization to aspirin and subsequent treatment with daily high-dose oral aspirin is standard of care for patients with AERD who do not respond adequately to steroids and have recurrent nasal polyposis or symptomatic asthma. This study will involve five visits to Brigham and Women's Hospital and will align closely with the standard of care for the treatment of AERD.
- Conditions
- Asthma, Aspirin-Induced
- Being tested
- aspirin
- Keywords
- asthma, nasal polyps, aspirin sensitivity, AERD
- Medical subject headings
- Asthma, Aspirin-Induced, Asthma, Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspirinDrug
| Study group | Role | What they receive |
|---|---|---|
| High-dose aspirin | Not described Receives: Drug: aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic efficacy of high-dose aspirin as assessed by asthma symptom control (Asthma Control Questionnaire)
Measured: 8 weeks
Therapeutic efficacy of high-dose aspirin as assessed by change in lung function
Measured: 8 weeks
Therapeutic efficacy of high-dose aspirin as assessed by change in sinus symptoms (Sino-Nasal Outcome Test)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startJul 2016
- Primary completion1 May 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Asthma, Aspirin-InducedStudies of the same condition, open and under way.
- More trials run by Brigham and Women's 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
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tanya Laidlaw, MD, Brigham and Women's Hospital
- Investigators
- Tanya M Laidlaw, MD, Principal investigator, Brigham and Women's HospitalKatherine C Cahill, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824523
- Sponsor's protocol ID
- 2016P001164
- Status last verified
- Sep 2022
- First submitted
- 24 Jun 2016
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Patel PP, Cui J, Cahill KN, Laidlaw TM. Objective validity of patient-reported symptoms in aspirin-exacerbated respiratory disease patients. Clin Exp Allergy. 2022 Feb;52(2):348-351. doi: 10.1111/cea.14062. Epub 2021 Dec 1. No abstract available.
PubMed 34820927Staso PJ, Wu P, Laidlaw TM, Cahill KN. Scoring tool for systemic symptoms during aspirin challenge detects mediator production in aspirin-exacerbated respiratory disease. Ann Allergy Asthma Immunol. 2021 Jul;127(1):131-133. doi: 10.1016/j.anai.2021.03.025. Epub 2021 Mar 27. No abstract available.
PubMed 33781934
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of PDG2 in the Aspirin-Induced Reactions and in the Treatment of Aspirin-Exacerbated Respiratory Disease
- ClinicalTrials.gov ID
- NCT02824523
- Acronym / sponsor ID
- 2016P001164
- Conditions
- Asthma, Aspirin-Induced
- Keywords
- asthma, nasal polyps, aspirin sensitivity, AERD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 6 Jul 2016 (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 purpose of this research study is to learn new information about the underlying cause of aspirin-exacerbated respiratory disease (AERD) and the benefit of high-dose aspirin therapy. AERD is a disease that involves asthma, recurring nasal polyps, and respiratory reactions to aspirin and other nonsteroidal anti-inflammatory drugs. This study will be conducted on individuals with AERD who are referred to the Brigham and Women's Hospital AERD Center for clinical evaluation and potential aspirin desensitization. Desensitization to aspirin and subsequent treatment with daily high-dose oral aspirin is standard of care for patients with AERD who do not respond adequately to steroids and have recurrent nasal polyposis or symptomatic asthma. This study will involve five visits to Brigham and Women's Hospital and will align closely with the standard of care for the treatment of AERD.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-dose aspirin | – | Drug: aspirin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with aspirin-exacerbated respiratory disease who are undergoing aspirin desensitization and starting high-dose aspirin therapy
Key inclusion criteria (5 listed)
- History of asthma
- History of nasal polyposis
- History of at least one clinical reaction to oral aspirin or other nonselective COX inhibitor with features of both lower (cough, chest tightness, wheezing, dyspnea) and upper (rhinorrhea, sneezing, nasal obstruction, conjunctival itching and discharge) airway involvement
- Stable asthma (post-bronchodilator FEV1 of ≥70%, no use of oral or systemic steroids for at least 1 month, and no hospitalizations or emergency room visits for asthma for the prior 6 months) at the time of entry into the study
- Currently taking montelukast as part of standard asthma treatment for at least 4 weeks before the V1 visit
Key exclusion criteria (9 listed)
- Pregnancy or current breastfeeding
- History of bleeding diathesis or use of anticoagulant or antiplatelet drugs
- History of thrombocytopenia < 50 x 10^9/L
- Hypersensitivity to montelukast
- Peptic ulcer disease
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 |
|---|---|---|
| aspirin | Drug | High-dose aspirin |
Primary outcome
Therapeutic efficacy of high-dose aspirin as assessed by asthma symptom control (Asthma Control Questionnaire)
Time frame: 8 weeks
Therapeutic efficacy of high-dose aspirin as assessed by change in lung function
Time frame: 8 weeks
Therapeutic efficacy of high-dose aspirin as assessed by change in sinus symptoms (Sino-Nasal Outcome Test)
Time frame: 8 weeks
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 30 Sep 2022.
- Derived from this study: PubMed 34820927Patel PP, Cui J, Cahill KN, Laidlaw TM. Objective validity of patient-reported symptoms in aspirin-exacerbated respiratory disease patients. Clin Exp Allergy. 2022 Feb;52(2):348-351. doi: 10.1111/cea.14062. Epub 2021 Dec 1. No abstract available.
- Derived from this study: PubMed 33781934Staso PJ, Wu P, Laidlaw TM, Cahill KN. Scoring tool for systemic symptoms during aspirin challenge detects mediator production in aspirin-exacerbated respiratory disease. Ann Allergy Asthma Immunol. 2021 Jul;127(1):131-133. doi: 10.1016/j.anai.2021.03.025. Epub 2021 Mar 27. No abstract available.
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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.
Tanya M Laidlaw, MD principal investigator
Brigham and Women's Hospital
Katherine C Cahill, MD principal investigator
Brigham and Women's 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 Asthma, Aspirin-Induced, run by Brigham and Women's 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 5 inclusion and 9 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 30 Sep 2022. 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 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?
Therapeutic efficacy of high-dose aspirin as assessed by asthma symptom control (Asthma Control Questionnaire) (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02824523, which also lists 2 linked publications.
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 30 Sep 2022.