Last updated on September 2020

Aspirin for Uncontrolled Asthma

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Uncontrolled Asthma
  • Age: Between 18 - 75 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Age : 18 to 75 years old
  • Patients receiving inhaled steroids (>1000 g/d beclomethasone or equivalent) combined with long acting beta agonist at a stable dose for at least 1 month and montelukast for at least 2 weeks.
  • Patients receiving Proton Pump Inhibitors for at least 2 weeks
  • Uncontrolled asthma defined by an ACQ 6 score1.5 at baseline
  • Recurrent chronic rhinosinusitis with nasal polyposis diagnosed by nasal endoscopy by an otorhinolaryngologist
  • Evidence of reversibility of airway obstruction defined as an increase of FEV1 of 12% or greater and at least 200 ml after Short Acting Beta Agonists (SABA) administration OR after oral corticoid test or an increase of CVF of 12% or greater and at least 200 ml after Short Acting Beta Agonists (SABA) administration or after oral corticoid test OR a variation in FEV1 of more than 200 ml and 12% between 2 follow-up visits OR variation of the Peak Expiratory Flow Rate (PEF) with a delta PEF over the day / average PEF over 2 weeks > 10% OR a positive methacholine bronchial challenge test: decrease in FEV1 by more than 20% for a dose < 1600 g documented once during medical history
  • FEV1>1.5l and 60% of predicted value at inclusion
  • Never smoked or non-smoker for at least 6 months, with a smoking history of no more than 10 pack-years
  • Written informed consent
  • Efficient contraception, other than an intrauterine device (IUD), for women of reproductive age

Exclusion Criteria:

  • Evidence of another clinically significant, active pulmonary disorder (bronchiectasis, chronic obstructive pulmonary disease (COPD), ) that could influence asthma control evaluation
  • Patient treated regularly with aspirin or NSAID for another pathology
  • Hypersensitive response to lansoprazole
  • treatment by nelfinavir or other HIV protease inhibitors for which absorption depends on gastric pH (atazanavir...)
  • Asthma exacerbation within the 4 weeks prior to inclusion (as defined by an oral corticotherapy for more than 48h or a 2-fold increase of oral corticoid intake )
  • Pregnancy or breast feeding
  • Recent myocardial infarction within the 6 months prior to inclusion
  • immunodeficiency
  • Patients receiving bet-blockers
  • Contra-indication for aspirin : history of gastro-intestinal or cerebral bleeding, active gastric or duodenal ulcer, major surgery within the 4 weeks prior to inclusion, treatment with methotrexate, probenecid, selective serotonin re-uptake inhibitor, diuretic, angiotensin-converting-enzyme inhibitor, angiotensin receptor inhibitor or anti-platelet drug, ,any hemorrhagic risk according to the investigator, heart, liver or kidney failure, hyperuricemia, phenylketonuria.
  • Major surgery planned during the 6 month study period
  • under security or legal protection measures
  • patient intolerant to lactose or other excipient
  • Patient with intra-uterine device
  • patient who has not given written consent
  • Non affiliation to a social security scheme (beneficiary or assignee)

Secondary exclusion criteria :

-Patients who will require epinephrine injection or transfer to ICU or patients who do not reach the maximum dose of 600mg during aspirin challenge-desensitization will stop the study and not be randomized

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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