CClinicalTrials.gg
Sign In
CompletedNCT02824523Updated Sep 30, 2022

Role of Inflammatory Mediators in AERD

An observational study in Asthma, Aspirin-Induced, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-09-30.

Sponsored by Brigham and Women's Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
40
Ages
18 Years to 75 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Asthma, Aspirin-Induced

Keywords

  • asthma
  • nasal polyps
  • aspirin sensitivity
  • AERD
03

In context

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with aspirin-exacerbated respiratory disease who are undergoing aspirin desensitization and starting high-dose aspirin therapy

Inclusion criteria

  • 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

Exclusion criteria

Exclusion criteria:

  • 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)
  • 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
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
40 participants (actual)
Patient registry
No

Groups and cohorts

  • High-dose aspirin

    Drug: aspirin

Interventions

  • Drugaspirin
06

What researchers measure

Primary outcomes

  1. Therapeutic efficacy of high-dose aspirin as assessed by asthma symptom control (Asthma Control Questionnaire)

    Time frame: 8 weeks

  2. Therapeutic efficacy of high-dose aspirin as assessed by change in lung function

    Time frame: 8 weeks

  3. Therapeutic efficacy of high-dose aspirin as assessed by change in sinus symptoms (Sino-Nasal Outcome Test)

    Time frame: 8 weeks

07

Study locations

1 site
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
08

References and documents

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 34820927 ↗
  • Staso 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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02824523
Lead sponsor
Brigham and Women's Hospital
Responsible party
Tanya Laidlaw, MD (Associate Physician, Brigham and Women's Hospital) — Principal investigator
First posted
Jul 6, 2016
Start date
Jul 2016
Primary completion
May 1, 2021
Completion
May 1, 2021
Last update
Sep 30, 2022

Study contacts

Tanya M Laidlaw, MD
principal investigator · Brigham and Women's Hospital
Katherine C Cahill, MD
principal investigator · Brigham and Women's Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Asthma, Aspirin-Induced

Other studies from this sponsor

Brigham and Women's Hospital

Start the discussion