NCT02906761

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
2.3 years until next milestone

Study Start

First participant enrolled

January 15, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2021

Completed
Last Updated

September 8, 2022

Status Verified

September 1, 2022

Enrollment Period

2.4 years

First QC Date

September 1, 2016

Last Update Submit

September 7, 2022

Conditions

Uncontrolled Asthma

Keywords

asthma, aspirin

Outcome Measures

Primary Outcomes (1)

  • Change in asthma Control Questionnaire (ACQ 6) score between baseline and 6 months

    Patients will fill in ACQ6 at each visit (day 0, 1 month, 3 months and 6 months)

    6 months

Secondary Outcomes (14)

  • Forced expired volume in 1 second (FEV1) variation between baseline and 6 months

    6 months

  • number of exacerbations

    6 months

  • Time to first exacerbation

    6 months

  • number of hospitalization

    6 months

  • oral steroid use

    6 months

  • +9 more secondary outcomes

Study Arms (2)

Aspirin

EXPERIMENTAL

Aspirin 600 mg (2 tablets of 300 mg) twice daily for 6 months

Drug: Aspirin

Placebo

PLACEBO COMPARATOR

Placebo (2 tablets) twice daily for 6 months

Drug: Placebo

Interventions

AspirinDRUG

Aspirin 600 mg (2 tablets of 300 mg) twice daily for 6 months

Also known as: acetylsalicylic acid
Aspirin
PlaceboDRUG

Placebo (2 tablets) twice daily for 6 months

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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...)
  • Pregnancy or breast feeding
  • immunodeficiency
  • Patients receiving bet-blockers
  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Service de pneumologie - CHU Besançon

Besançon, France

Location

Service de Pneumologie - Hôpital François Mitterrand - CHU Dijon

Dijon, 21000, France

Location

Service de Pneumologie - Hôpital Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

Service de pneumologie - Hôpital Calmette - CHRU Lille

Lille, 59037, France

Location

Service de Pneumologie - La Croix Rousse

Lyon, 69004, France

Location

CIC - Hôpital Bichat

Paris, 75018, France

Location

Service de pneumologie - Hôpital Charles Nicolle - CHU Rouen

Rouen, France

Location

Service de pneumologie - Nouvel Hopital Civil - CHU strasbourg

Strasbourg, France

Location

Service de pneumologie - Hôpital Larrey

Toulouse, 31009, France

Location

MeSH Terms

Conditions

Asthma

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2016

First Posted

September 20, 2016

Study Start

January 15, 2019

Primary Completion

June 17, 2021

Study Completion

June 17, 2021

Last Updated

September 8, 2022

Record last verified: 2022-09

Locations

FR(9)