Uncontrolled AsthmaPhase 3ASTHMIRINENCT02906761
Aspirin for Uncontrolled Asthma
A Phase 3 study testing Aspirin in people with Uncontrolled Asthma, run by Assistance Publique - Hôpitaux de Paris at 9 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Uncontrolled Asthma
- What is being tested?
- Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 9 sitesFrance
- Study dates
- 15 Jan 2019to 17 Jun 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Service de pneumologie - CHU Besançon
Besançon
Service de Pneumologie - Hôpital François Mitterrand - CHU Dijon
Dijon, 21000
Service de Pneumologie - Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
Service de pneumologie - Hôpital Calmette - CHRU Lille
Lille, 59037
Service de Pneumologie - La Croix Rousse
Lyon, 69004
CIC - Hôpital Bichat
Paris, 75018
Service de pneumologie - Hôpital Charles Nicolle - CHU Rouen
Rouen
Service de pneumologie - Nouvel Hopital Civil - CHU strasbourg
Strasbourg
Service de pneumologie - Hôpital Larrey
Toulouse, 31009
About this study
Official title: Aspirin for Uncontrolled Asthma : a Randomized Controlled Study
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.
Read the detailed description
Asthma concerns about 7% of the French adult population. About 10% of them have uncontrolled disease, despite high doses of inhaled steroids combined with long acting beta 2 agonists and adequate management of aggravating factors. They account for considerable asthma morbidity, mortality and costs. New treatments are needed for these patients.
Asthma is characterized by changes in eicosanoids metabolism, especially high production of bronchoconstrictive cysteinyl leukotrienes and 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, as demonstrated in other models.
Interest for aspirin is also supported by data obtained in asthma patients with aspirin intolerance (Aspirin induced asthma, AIA), who are characterized by a severe difficult-to-treat respiratory disease frequently associated with nasal polyposis, overproduction of leukotrienes and increased expression of leukotriene receptors. In this particular group of patients, aspirin treatment significantly improves nasal symptoms, quality of life, asthma and rhinitis scores, and reduces need for hospitalizations and nasal surgery. A reduction in oral steroids use was observed in most series. In this group of patients, aspirin also induced a decrease in interleukin 4 (IL-4) and Matrix metallopeptidase 9 (MMP-9) levels in sputum in asthma patients thus providing another explanation for anti inflammatory effect of aspirin in asthma. Patients treated with higher doses of aspirin (650 mg BID) had more favorable courses than those treated with lower doses.Aspirin desensitization is considered as a cost-effective therapeutic intervention in patients with moderate-to-severe AIA However, some of these studies, coming mostly from the same team, can be criticized for methodological reasons, low evidence, small series, and weak asthma characterization.
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. Because similar changes in eicosanoid metabolism are described in nasal polyps mucosa, a pathology frequently associated with asthma, we hypothesize that patients with nasal polyps and asthma could be a specific target for aspirin treatment.
Aspirin is a cheap treatment, compared with biotherapies developed for severe asthma.
Hypothesis The investigators propose to compare the effect aspirin (600 mg twice daily) versus placebo, given during six months, on asthma control in patients with uncontrolled asthma and nasal polyposis, whatever their aspirin level of tolerance, in a randomized, double blind, placebo-controlled trial.
Study objectives Primary objective 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.
Secondary objectives
To assess the effect of long term aspirin treatment compared to placebo, in patients with uncontrolled disease and nasal polyposis, on the following criteria:
- lung function
- number of exacerbations
- time to the first exacerbation
- oral and inhaled steroid use and doses
- Nasal symptoms
- Nasal sinus symptoms severity
- quality of life
- Lipoxin A4, cysteinyl leukotrienes (cystLT) and LTB4 levels in sputum
- Reactions during oral aspirin challenge
- Gastro-intestinal and other bleedings
Study design This is a multicentric, randomized, placebo-controlled, double-blinded phase III clinical trial.
- Conditions
- Uncontrolled Asthma
- Being tested
- Aspirin, Placebo
- Keywords
- asthma, aspirin
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Also called acetylsalicylic acid
Aspirin 600 mg (2 tablets of 300 mg) twice daily for 6 months
PlaceboDrug
Placebo (2 tablets) twice daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Experimental | Aspirin 600 mg (2 tablets of 300 mg) twice daily for 6 months Receives: Drug: Aspirin |
| Placebo | Placebo comparator | Placebo (2 tablets) twice daily for 6 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (14)
Forced expired volume in 1 second (FEV1) variation between baseline and 6 months
A spirometry will be done at each visit (day 0, 1 month, 3 months and 6 months)
Measured: 6 months
number of exacerbations
The number of exacerbations will be assessed at each visit (day 0, 1 month, 3 months and 6 months)
Measured: 6 months
Time to first exacerbation
Time to first exacerbation will be assessed at each visit (day 0, 1 month, 3 months and 6 months)
Measured: 6 months
number of hospitalization
number of hospitalization
Measured: 6 months
oral steroid use
oral steroid use
Measured: 6 months
inhaled steroid doses
inhaled steroid doses
Measured: 6 months
nasal sinus symptoms severity at baseline and 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)
Measured: 6 months
measure of quality of life: AQLQ
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.
Measured: 6 months
Lipoxin A4 (LXA4) levels in sputum
LXA4 levels at day 0 and 6 months will be measured by ELISA kit
Measured: 6 months
Cyst-LT levels in sputum
Cyst-LT levels at day 0 and 6 months will be measured by ELISA kit
Measured: 6 months
LTB4 levels in sputum
LTB4 levels at day 0 and 6 months will be measured by ELISA kit
Measured: 6 months
Reactions during oral aspirin challenge test
Occurrence of intolerance symptom : angioedema, bronchospasm, rhinitis, urticaria...
Measured: 3 to 4 days
Digestive tolerance during treatment
Medical examination, patient interview
Measured: 6 months
gastro-intestinal bleedings during treatment
Occurence by bleedings during treatment, patient interview
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study start15 Jan 2019
- Primary completion17 Jun 2021
- Study completion17 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncontrolled AsthmaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906761
- Sponsor's protocol ID
- P130954
- Other IDs
- 2016-000739-42, 2016
- Acronym
- ASTHMIRINE
- Status last verified
- Sep 2022
- First submitted
- 1 Sep 2016
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspirin for Uncontrolled Asthma : a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02906761
- Acronym / sponsor ID
- ASTHMIRINE / P130954
- Conditions
- Uncontrolled Asthma
- Keywords
- asthma, aspirin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 17 Jun 2021 (actual)
- Study completion
- 17 Jun 2021 (actual)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Asthma concerns about 7% of the French adult population. About 10% of them have uncontrolled disease, despite high doses of inhaled steroids combined with long acting beta 2 agonists and adequate management of aggravating factors. They account for considerable asthma morbidity, mortality and costs. New treatments are needed for these patients.
Asthma is characterized by changes in eicosanoids metabolism, especially high production of bronchoconstrictive cysteinyl leukotrienes and 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, as demonstrated in other models.
Interest for aspirin is also supported by data obtained in asthma patients with aspirin intolerance (Aspirin induced asthma, AIA), who are characterized by a severe difficult-to-treat respiratory disease frequently associated with nasal polyposis, overproduction of leukotrienes and increased expression of leukotriene receptors. In this particular group of patients, aspirin treatment significantly improves nasal symptoms, quality of life, asthma and rhinitis scores, and reduces need for hospitalizations and nasal surgery. A reduction in oral steroids use was observed in most series. In this group of patients, aspirin also induced a decrease in interleukin 4 (IL-4) and Matrix metallopeptidase 9 (MMP-9) levels in sputum in asthma patients thus providing another explanation for anti inflammatory effect of aspirin in asthma. Patients treated with higher doses of aspirin (650 mg BID) had more favorable courses than those treated with lower doses.Aspirin desensitization is considered as a cost-effective therapeutic intervention in patients with moderate-to-severe AIA However, some of these studies, coming mostly from the same team, can be criticized for methodological reasons, low evidence, small series, and weak asthma characterization.
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. Because similar changes in eicosanoid metabolism are described in nasal polyps mucosa, a pathology frequently associated with asthma, we hypothesize that patients with nasal polyps and asthma could be a specific target for aspirin treatment.
Aspirin is a cheap treatment, compared with biotherapies developed for severe asthma.
Hypothesis The investigators propose to compare the effect aspirin (600 mg twice daily) versus placebo, given during six months, on asthma control in patients with uncontrolled asthma and nasal polyposis, whatever their aspirin level of tolerance, in a randomized, double blind, placebo-controlled trial.
Study objectives Primary objective 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.
Secondary objectives
To assess the effect of long term aspirin treatment compared to placebo, in patients with uncontrolled disease and nasal polyposis, on the following criteria:
- lung function
- number of exacerbations
- time to the first exacerbation
- oral and inhaled steroid use and doses
- Nasal symptoms
- Nasal sinus symptoms severity
- quality of life
- Lipoxin A4, cysteinyl leukotrienes (cystLT) and LTB4 levels in sputum
- Reactions during oral aspirin challenge
- Gastro-intestinal and other bleedings
Study design This is a multicentric, randomized, placebo-controlled, double-blinded phase III clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin | Experimental | Drug: AspirinAspirin 600 mg (2 tablets of 300 mg) twice daily for 6 months |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (2 tablets) twice daily for 6 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (18 listed)
- 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 )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AspirinAlso: acetylsalicylic acidAspirin 600 mg (2 tablets of 300 mg) twice daily for 6 months | Drug | Aspirin |
| PlaceboPlacebo (2 tablets) twice daily for 6 months | Drug | Placebo |
Primary outcome
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)
14 secondary outcomes
Forced expired volume in 1 second (FEV1) variation between baseline and 6 months
Time frame: 6 months
number of exacerbations
Time frame: 6 months
Time to first exacerbation
Time frame: 6 months
number of hospitalization
Time frame: 6 months
oral steroid use
Time frame: 6 months
inhaled steroid doses
Time frame: 6 months
nasal sinus symptoms severity at baseline and 6 months
Time frame: 6 months
measure of quality of life: AQLQ
Time frame: 6 months
Lipoxin A4 (LXA4) levels in sputum
Time frame: 6 months
Cyst-LT levels in sputum
Time frame: 6 months
LTB4 levels in sputum
Time frame: 6 months
Reactions during oral aspirin challenge test
Time frame: 3 to 4 days
Digestive tolerance during treatment
Time frame: 6 months
gastro-intestinal bleedings during treatment
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aspirin in people with Uncontrolled Asthma, run by Assistance Publique - Hôpitaux de Paris at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in asthma Control Questionnaire (ACQ 6) score between baseline and 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.