Asthma is characterized by changes in eicosanoids metabolism, especially high production of bronchoconstrictive cysteinyl leukotrienes (CystLTBs) and leukotriene B4 (LTB4). Recent studies have also demonstrated a relative low production of lipoxin A4, an endogenous lipid mediator resulting from lipo-oxygenase action, distinct from CystLTBs, with anti-inflammatory properties, in bronchial epithelial cells and lung macrophages of severe asthma patients, leading to imbalance between pro-resolving and pro-inflammatory eicosanoids production in airways. Such data suggest that aspirin, that induces lipoxins production, could restore lipoxins deficit in severe asthma. Interest for aspirin is also supported by data obtained in asthma patients with aspirin intolerance (Aspirin induced asthma, AIA) : in this particular group of patients, aspirin treatment significantly improves nasal symptoms, quality of life, asthma and rhinitis scores, and reduces need for hospitalizations, nasal surgery and oral steroids use. Potential effect of aspirin in patients with uncontrolled asthma without aspirin intolerance, who presented changes in arachidonic acid pathway close to those observed in AIA, is not established.
The aim of the study is to assess whether long term aspirin treatment could improve asthma control, compared to placebo, in patients with uncontrolled disease and nasal polyposis, whatever their aspirin tolerance level.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 180 participants
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Aspirin for Uncontrolled Asthma : a Randomized Controlled Study
Actual Study Start Date: January 15, 2019
Estimated Primary Completion Date: July 2022
Estimated Study Completion Date: January 2023
- Experimental: Aspirin
- Placebo Comparator: Placebo
|Date last updated at source||2019-05-27|
|Study start date||2019-01-15|
|Estimated primary completion date||2022-07-01|