Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:44 PM
Ignite Modification Date:
2025-12-24 @ 12:44 PM
NCT ID:
NCT02906761
Eligibility Criteria:
Inclusion Criteria:
* Age : 18 to 75 years old
* Patients receiving inhaled steroids (\>1000 µg/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 score≥1.5 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 µg 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02906761
Study Brief:
Protocol Section:
NCT02906761