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Aspirin for Uncontrolled Asthma (ASTHMIRINE)

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ClinicalTrials.gov Identifier: NCT02906761
Recruitment Status : Recruiting
First Posted : September 20, 2016
Last Update Posted : May 27, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Uncontrolled Asthma Drug: Aspirin Drug: Placebo Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: Aspirin
Aspirin 600 mg (2 tablets of 300 mg) twice daily for 6 months
Drug: Aspirin
Aspirin 600 mg (2 tablets of 300 mg) twice daily for 6 months
Other Name: acetylsalicylic acid

Placebo Comparator: Placebo
Placebo (2 tablets) twice daily for 6 months
Drug: Placebo
Placebo (2 tablets) twice daily for 6 months




Primary Outcome Measures :
  1. Change in asthma Control Questionnaire (ACQ 6) score between baseline and 6 months [ Time Frame: 6 months ]
    Patients will fill in ACQ6 at each visit (day 0, 1 month, 3 months and 6 months)


Secondary Outcome Measures :
  1. Forced expired volume in 1 second (FEV1) variation between baseline and 6 months [ Time Frame: 6 months ]
    A spirometry will be done at each visit (day 0, 1 month, 3 months and 6 months)

  2. number of exacerbations [ Time Frame: 6 months ]
    The number of exacerbations will be assessed at each visit (day 0, 1 month, 3 months and 6 months)

  3. Time to first exacerbation [ Time Frame: 6 months ]
    Time to first exacerbation will be assessed at each visit (day 0, 1 month, 3 months and 6 months)

  4. number of hospitalization [ Time Frame: 6 months ]
    number of hospitalization

  5. oral steroid use [ Time Frame: 6 months ]
    oral steroid use

  6. inhaled steroid doses [ Time Frame: 6 months ]
    inhaled steroid doses

  7. nasal sinus symptoms severity at baseline and 6 months [ Time Frame: 6 months ]

    Patients will fill in Sino-Nasal Outcome Test 16 (SNOT 16) questionnaire at each visit .The SNOT-16 is a quality of life, self-administered questionnaire comprising 16 questions.

    Responses are scored as: 0 = no bother, 1 = mild or minor bother, 2 = moderate bother, 3 = severe bother. Patients are also asked to check to five items which are most important to them personally. Scores range (sum of each question) from 0 (no functional bother) to 48 (maximal functional bother) (day 0, 1 months, 3 months and 6 months)


  8. measure of quality of life: AQLQ [ Time Frame: 6 months ]
    Patients will fill in Asthma Quality of Life Questionnaire (AQLQ) at each visit (day 0, 1 months, 3 months and 6 months). There are 32 questions in the AQLQ and they are in 4 domains (symptoms, activity limitation, emotional function and environmental stimuli). The activity domain contains 5 'patient-specific' questions. This allows patients to select 5 activities in which they are most limited and these activities will be assessed at each follow-up. Patients are asked to think about how they have been during the previous two weeks and to respond to each of the 32 questions on a 7-point scale (7 = not impaired at all - 1 = severely impaired). The overall AQLQ score is the mean of all 32 responses and the individual domain scores are the means of the items in those domains.

  9. Lipoxin A4 (LXA4) levels in sputum [ Time Frame: 6 months ]
    LXA4 levels at day 0 and 6 months will be measured by ELISA kit

  10. Cyst-LT levels in sputum [ Time Frame: 6 months ]
    Cyst-LT levels at day 0 and 6 months will be measured by ELISA kit

  11. LTB4 levels in sputum [ Time Frame: 6 months ]
    LTB4 levels at day 0 and 6 months will be measured by ELISA kit

  12. Reactions during oral aspirin challenge test [ Time Frame: 3 to 4 days ]
    Occurrence of intolerance symptom : angioedema, bronchospasm, rhinitis, urticaria...

  13. Digestive tolerance during treatment [ Time Frame: 6 months ]
    Medical examination, patient interview

  14. gastro-intestinal bleedings during treatment [ Time Frame: 6 months ]
    Occurence by bleedings during treatment, patient interview



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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, 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
  • Hypersensitive response to benzimidazole derivatives or nelfinavir intake
  • 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 or previous cancer history
  • 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 during aspirin challenge-desensitization will stop the study and not be randomized.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02906761


Contacts
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Contact: Camille TAILLE, MD, PhD 01 40 25 68 00 camille.taille@aphp.fr
Contact: Aline DECHANET 0140257830 aline.dechanet@aphp.fr

Locations
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France
Service de Pneumologie - Hôpital François Mitterrand - CHU Dijon Active, not recruiting
Dijon, France, 21000
Service de Pneumologie - Hôpital Bicêtre Active, not recruiting
Le Kremlin Bicetre, France, 94270
Service de pneumologie - Hôpital Calmette - CHRU Lille Active, not recruiting
Lille, France, 59037
Service de Pneumologie - La Croix Rousse Active, not recruiting
Lyon, France, 69004
Clinique des bronches, de l'allergie et du sommeil Hôpital Nord Active, not recruiting
Marseille, France, 13000
Service de pneumologie - CHU Nancy Active, not recruiting
Nancy, France, 54511
CIC - Hôpital Bichat Recruiting
Paris, France, 75018
Contact: Loubna ALAVOINE       loubna.alavoine@aphp.fr   
Contact: Camille TAILLE       camille.taille@aphp.fr   
Service de pneumologie - Hôpital Larrey Active, not recruiting
Toulouse, France, 31009
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02906761     History of Changes
Other Study ID Numbers: P130954
2016-000739-42 ( EudraCT Number )
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: May 27, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
asthma, aspirin

Additional relevant MeSH terms:
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Aspirin
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics