AsthmaAPEXANCT05253391
Adequacy of Management of Patients With Asthma Exacerbation in Martinique
An observational study of Asthma, run by University Hospital Center of Martinique at 7 sites in Martinique.
Trial summary
Asthma is a chronic respiratory disease whose goal of therapeutic, educational and preventive care is to prevent the onset of acute crisis, the most serious of which are life threatening. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Routine care
- How many people
- 339 participants
- Where
- 7 sitesMartinique
- Study dates
- 10 Oct 2022to 10 Aug 2024
- Phase
- Observational
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated for asthma exacerbation.
Who may be able to join
- All children and adolescents (2-17 years) and adults (≥ 18 years) asthma patients.
- Supported either by a team from mobile emergency and resuscitation service (SMUR) participating in the study, or by a team from the Emergency Department or possibly admitted directly to an intensive care unit participating in the study.
- With an asthma exacerbation (acute asthma), the diagnostic criteria of which are as follows: history of asthma or wheezing dyspnea, exacerbation of wheezing, difficulty breathing, shortness of breath, wheezing or dry cough, and finally wheezing or silence on auscultation.
- Patient or patient representative who has given oral consent for the use of their medical data for this research.
Who cannot join
- Patient with a strong suspicion or a proven diagnosis of acute respiratory failure on chronic respiratory failure.
- Patient with a strong suspicion or a proven diagnosis of acute left heart failure with wheezing (cardiac asthma) or crackling rales.
- Patient with a strong suspicion or a proven diagnosis of acute febrile pneumonitis.
- Patient with a strong suspicion or a proven diagnosis of acute pleurisy (reduction or elimination of vesicular murmurs, dullness of the bases or imaging).
- Patient or representative of the patient who refused to agree to his participation in the study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Martinique7 sites, 7 recruiting
- Recruiting
CHU of Martinique - Emergency Department of Pierre Zobda Quitman
Fort-de-France, 97261
Yannick BROUSTE, MD, 05 96 30 64 70 ext. +596, yannick.brouste@chu-martinique.fr
- Recruiting
CHU of Martinique - Pediatric Emergency Unit
Fort-de-France, 97261
Odile OXYBEL, MD, 05 96 55 69 55 ext. +596, odile.oxybel@chu-martinique.fr
- Recruiting
CHU of Martinique - Pediatric Resuscitation Unit
Fort-de-France, 97261
Jérôme PIGNOL, MD, 05 96 55 31 10 ext. +596, jerome.pignol@chu-martinique.fr
- Recruiting
CHU of Martinique - Pneumology Service
Fort-de-France, 97261
Moustapha AGOSSOU, MD, 05 96 55 23 61 ext. +596, moustapha.agossou@chu-martinique.fr
- Recruiting
CHU of Martinique - Resuscitation Unit
Fort-de-France, 97261
Cyrill CHABARTIER, MD, 05 96 30 62 94 ext. +596, cyrill.chabartier@chu-martinique.fr
- Recruiting
CHU of Martinique - SAMU/SMUR
Fort-de-France, 97261
Papa GUEYE, MD, 05 96 55 20 15 ext. +596, papa.gueye@chu-martinique.fr
- Recruiting
CHU of Martinique - Emergency Department of Trinité
La Trinité, 97223
Céline MAISONDIEU, MD, 05 96 66 46 24 ext. +596, celine.maisondieu@chu-martinique.fr
About this study
Asthma is a chronic respiratory disease whose goal of therapeutic, educational and preventive care is to prevent the onset of acute crisis, the most serious of which are life threatening. A general population survey shows a greater prevalence of asthma in the French West Indies compared to hexagonal France, but there is no data to our knowledge on asthma exacerbations requiring pre and intra-hospital emergency services, nor on the clinical severity or on the adequacy of the therapeutic care.
Asthma exacerbations, in particular serious forms requiring immediate admission to the Emergency Department or Intensive Care Unit or leading to hospitalization, can be considered as a failure in the prevention of crisis and therefore disease control. The management of acute or subacute asthma exacerbations is however well codified in expert recommendations, renewed annually by the Global Initiative for Asthma (GINA). These recommendations specify not only the initial care, but also the strategy and modalities of return home and post-emergency follow-up. Recently the French Language Resuscitation Society (SRLF) and the French Society of Emergency Medicine (SFMU) jointly published formalized expert recommendations (RFE) on the management of asthma exacerbations (Le Conte 2019).
These RFEs still remain the benchmark in France for adequate management of asthma exacerbations for adults and children. Despite these updated recommendations, field observations often show inadequate care, both in the emergency and in the post-emergency period.
Read the detailed description
The rationale for this study is based on the lack of data concerning the characteristics of asthma exacerbations and their emergency management in Martinique, but also the lack of awareness of the adequacy of this management according to the stage of severity, as recommended.
Better knowledge of asthma exacerbations, of the stage of clinical severity, of emergency treatments and of post-emergency follow-up, would improve the overall care of asthma patients in Martinique and induce a better control their disease.
This prospective clinical research includes all the services of the Martinique University Hospital which take care of asthma patients during or after their exacerbation: Emergency medical assistance service (SAMU), Mobile emergency and resuscitation structure (SMUR), adult and pediatric emergency services, adult and pediatric resuscitation and pulmonology service.
In order not to guide or influence the therapeutic decisions of the investigators in charge of the patients in this study, and because the evaluation of the adequacy of the management according to the stage of severity is the main objective of the study, no recommendations or instructions are given to the investigators. Each investigator freely decides on the treatment (diagnosis, assessment of severity, treatment, modalities and prescription for discharge from emergencies, hospitalization or not).
This research is the first assessment of asthma exacerbations carried out in our region with the aim of improving their management in order to limit their prognostic impact.
- Conditions
- Asthma
- Being tested
- Routine care
- Keywords
- Asthma, Asthma exacerbation, Acute asthma, Emergency, Asthma treatment, French West Indies
- Medical subject headings
- Asthma, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine careOther
The investigator takes care of the patient according to the protocol in force in his department and decides on the final orientation of the patient (transfer to intensive care unit/ICU, hospitalization or home discharge).
No recommendations or instructions are given to the investigators. Each investigator is free to decide on his care and the terms of transfer, hospitalization and discharge.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated for asthma exacerbation | Not described Receives: Other: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the adequacy of the management of acute asthma exacerbations according to the stage of severity for patients treated at the CHU of Martinique.
Percentage of patients who received adequate management by stage of severity of acute exacerbation. A tool to assist in the management of an exacerbation of asthma is described to define adequate or non-adequate management by an expert committee.
Measured: 19 months
Secondary outcomes (6)
Describe the distribution of the different stages of severity of asthma exacerbations.
Percentage of each of the 3 severity stages of acute asthma exacerbations.
Measured: 19 months
Measure the hospitalization rate according to the stage of severity of the asthma exacerbations.
Hospitalization rate (emergency unit, intensive care unit or medical or pneumology department) according to the initial stage of severity.
Measured: 19 months
Measure the rate of recurrence of exacerbation (for SAMU, Emergencies, resuscitation or hospitalization) within 30 days of the initial crisis.
Acute exacerbation recurrence rate (SAMU, Emergency, resuscitation or hospitalization) within 30 days of the first inclusion.
Measured: 19 months
Measure the incidence during the study period of asthma exacerbations treated urgently at the CHU of Martinique.
Incidence rate of acute exacerbations during the study period.
Measured: 19 months
Measure the proportion of patients having an exit treatment including a background treatment.
Proportion of patients having an exit treatment including a background treatment.
Measured: 19 months
Measure the proportion of patients who actually took their background treatment at day 30 after the crisis.
Proportion of patients who actually took their background treatment at day 30 after the crisis.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start10 Oct 2022
- Primary completion10 Jul 2024 (estimated)
- Study completion10 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 339 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253391
- Sponsor's protocol ID
- 20_RIPH3-18
- Acronym
- APEXA
- Status last verified
- Mar 2023
- First submitted
- 28 Jan 2022
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adequacy of Management of Patients With Asthma Exacerbation in Martinique
- ClinicalTrials.gov ID
- NCT05253391
- Acronym / sponsor ID
- APEXA / 20_RIPH3-18
- Conditions
- Asthma
- Keywords
- Asthma, Asthma exacerbation, Acute asthma, Emergency, Asthma treatment, French West Indies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 339 participants (estimated)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 10 Jul 2024 (estimated)
- Study completion
- 10 Aug 2024 (estimated)
- First posted
- 23 Feb 2022 (actual)
- 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 a chronic respiratory disease whose goal of therapeutic, educational and preventive care is to prevent the onset of acute crisis, the most serious of which are life threatening. A general population survey shows a greater prevalence of asthma in the French West Indies compared to hexagonal France, but there is no data to our knowledge on asthma exacerbations requiring pre and intra-hospital emergency services, nor on the clinical severity or on the adequacy of the therapeutic care.
Asthma exacerbations, in particular serious forms requiring immediate admission to the Emergency Department or Intensive Care Unit or leading to hospitalization, can be considered as a failure in the prevention of crisis and therefore disease control. The management of acute or subacute asthma exacerbations is however well codified in expert recommendations, renewed annually by the Global Initiative for Asthma (GINA). These recommendations specify not only the initial care, but also the strategy and modalities of return home and post-emergency follow-up. Recently the French Language Resuscitation Society (SRLF) and the French Society of Emergency Medicine (SFMU) jointly published formalized expert recommendations (RFE) on the management of asthma exacerbations (Le Conte 2019).
These RFEs still remain the benchmark in France for adequate management of asthma exacerbations for adults and children. Despite these updated recommendations, field observations often show inadequate care, both in the emergency and in the post-emergency period.
Detailed description
The rationale for this study is based on the lack of data concerning the characteristics of asthma exacerbations and their emergency management in Martinique, but also the lack of awareness of the adequacy of this management according to the stage of severity, as recommended.
Better knowledge of asthma exacerbations, of the stage of clinical severity, of emergency treatments and of post-emergency follow-up, would improve the overall care of asthma patients in Martinique and induce a better control their disease.
This prospective clinical research includes all the services of the Martinique University Hospital which take care of asthma patients during or after their exacerbation: Emergency medical assistance service (SAMU), Mobile emergency and resuscitation structure (SMUR), adult and pediatric emergency services, adult and pediatric resuscitation and pulmonology service.
In order not to guide or influence the therapeutic decisions of the investigators in charge of the patients in this study, and because the evaluation of the adequacy of the management according to the stage of severity is the main objective of the study, no recommendations or instructions are given to the investigators. Each investigator freely decides on the treatment (diagnosis, assessment of severity, treatment, modalities and prescription for discharge from emergencies, hospitalization or not).
This research is the first assessment of asthma exacerbations carried out in our region with the aim of improving their management in order to limit their prognostic impact.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated for asthma exacerbation | – | Other: Routine care |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated for asthma exacerbation.
Key inclusion criteria (4 listed)
- All children and adolescents (2-17 years) and adults (≥ 18 years) asthma patients.
- Supported either by a team from mobile emergency and resuscitation service (SMUR) participating in the study, or by a team from the Emergency Department or possibly admitted directly to an intensive care unit participating in the study.
- With an asthma exacerbation (acute asthma), the diagnostic criteria of which are as follows: history of asthma or wheezing dyspnea, exacerbation of wheezing, difficulty breathing, shortness of breath, wheezing or dry cough, and finally wheezing or silence on auscultation.
- Patient or patient representative who has given oral consent for the use of their medical data for this research.
Key exclusion criteria (5 listed)
- Patient with a strong suspicion or a proven diagnosis of acute respiratory failure on chronic respiratory failure.
- Patient with a strong suspicion or a proven diagnosis of acute left heart failure with wheezing (cardiac asthma) or crackling rales.
- Patient with a strong suspicion or a proven diagnosis of acute febrile pneumonitis.
- Patient with a strong suspicion or a proven diagnosis of acute pleurisy (reduction or elimination of vesicular murmurs, dullness of the bases or imaging).
- Patient or representative of the patient who refused to agree to his participation in the study.
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 |
|---|---|---|
| Routine careThe investigator takes care of the patient according to the protocol in force in his department and decides on the final orientation of the patient (transfer to intensive care unit/ICU, hospitalization or home discharge). No recommendations or instructions are given to the investigators. Each investigator is free to decide on his care and the terms of transfer, hospitalization and discharge. | Other | Patients treated for asthma exacerbation |
Primary outcome
To assess the adequacy of the management of acute asthma exacerbations according to the stage of severity for patients treated at the CHU of Martinique.
Time frame: 19 months
Percentage of patients who received adequate management by stage of severity of acute exacerbation. A tool to assist in the management of an exacerbation of asthma is described to define adequate or non-adequate management by an expert committee.
6 secondary outcomes
Describe the distribution of the different stages of severity of asthma exacerbations.
Time frame: 19 months
Measure the hospitalization rate according to the stage of severity of the asthma exacerbations.
Time frame: 19 months
Measure the rate of recurrence of exacerbation (for SAMU, Emergencies, resuscitation or hospitalization) within 30 days of the initial crisis.
Time frame: 19 months
Measure the incidence during the study period of asthma exacerbations treated urgently at the CHU of Martinique.
Time frame: 19 months
Measure the proportion of patients having an exit treatment including a background treatment.
Time frame: 19 months
Measure the proportion of patients who actually took their background treatment at day 30 after the crisis.
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Individual participant dataSharing planned: No
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by University Hospital Center of Martinique at 7 sites in Martinique.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Martinique. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Papa GUEYE, MD (05 96 55 20 15 ext. +596, papa.gueye@chu-martinique.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the adequacy of the management of acute asthma exacerbations according to the stage of severity for patients treated at the CHU of Martinique. (time frame: 19 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 6 Mar 2023.