Asthma AttackAERONCT03099915
Asthma Attack in the Emergency Department : Reasons Of This Attendance
An observational study of Asthma Attack and Emergency Medicine, run by Olivier CHASSANY at 2 sites in France.
Trial summary
Objective: Identify modifiable factors that may affect asthma control and the use of emergency room to define customized interventions for the management of asthma prior to emergency room. Emergency department attendance is always a sign of poor balance or control of asthma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma Attack, Emergency Medicine
- What is being tested?
- completion of self-reported questionnaires
- How many people
- 182 participants
- Where
- 2 sitesFrance
- Study dates
- 17 Mar 2017to 31 Dec 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults visiting emergency department for asthma attack
Who may be able to join
- Age> 18 years
- Ambulatory patient, visiting one of these centers
- Diagnosis of asthma already evolving for more than 6 months
- Prescription of treatment for more than 3 months
- Patient who can read and write French
- Agreement for an individual interview (Part 1) or fill up a self-questionnaire (Part 2)
- Health insurance coverage
Who cannot join
- Patients with other etiology that may explain their dyspnea: heart failure, chronic obstructive pulmonary disease , pneumopathy
- Patients with a social background that is not compatible with the study: a patient who does not speak French, is homeless or does not have a telephone number
- Inpatients
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service d'accueil des urgences Hôpital Beaujon
Clichy, 92110
Service d'acceuil des urgences hôpital Bichat- Claude Bernard
Paris, 75018
About this study
Objective: Identify modifiable factors that may affect asthma control and the use of emergency room to define customized interventions for the management of asthma prior to emergency room.
Emergency department attendance is always a sign of poor balance or control of asthma. In spite of a decrease in the number of deaths that has been halved in 20 years and hospitalization due to asthmatic disease, the use of emergency center for this disease has not decreased. We now know that the passage through emergencies and hospitalization for aggravation of asthma is in itself a factor of mortality. Acting on the determinants of poor balance or control of asthma is essential to further reduce the mortality and morbidity of asthma.
Read the detailed description
There is two parts in this study:
Part 1 - Qualitative study by individual interviews until data saturation (although about ten patients should be enough to capture the concepts of interest) on the factors that induce an imbalance of asthma (based on the GINA (Global Initiative for Asthma) report whose criteria are validated).
An interview guide will be written to systematically address all aspects related to asthma control.
In agreement with the patient the interview will be recorded, and the verbatim will be transcribed and coded using a software (Nvivo version 10).
Preparation of a questionnaire
A questionnaire will be developed from:
- analysis of patient verbatim
- other data: GINA criteria, psychological criteria (psychological distress is assessed by the 12-item general health questionnaire (GHQ-12) which is valid psychometric tools in French) and social criteria.
Part 2-Observational cohort qualitative study. The questionnaire thus prepared will be placed in the patient file upon admission. As soon as possible it will be filled by the patient after improvement of his condition and collected by the doctor or nurse who took care of the patient.
To obtain sufficient power to demonstrate significant associations, and assuming that 15 variables are taken into account in a multivariate model and based on the recommendations of 10 subjects per variable, 150 patients are required.
- Conditions
- Asthma Attack, Emergency Medicine
- Being tested
- completion of self-reported questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
completion of self-reported questionnairesOther
Single completion: Participants will have to complete self-reported questionnaires based on gina criteria and 12-item general health questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
Poor observance of GINA criteria
Explanation of Asthma imbalance by poor observance and knowledge of GINA global strategy for asthma management and prevention criteria.
Measured: Less than 24 hours: the outcome measure will be assessed the visiting day at emergency room, when the asthma attack will be solved, before discharge from hospital
Secondary outcomes (1)
GHQ-12 Psychometric tool
Psychological distress caused by asthma will be measured by general health questionnaire
Measured: Less than 24 hours: the outcome measure will be assessed the visiting day at emergency room, when the asthma attack will be solved, before discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start17 Mar 2017
- Primary completion30 Mar 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma AttackStudies 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
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olivier CHASSANY
- Sponsor type
- University, hospital or other
- Collaborators
- EA 7334, Patient-Centered Outcomes Research, Bichat Hospital, Beaujon Hospital
- Responsible party
- Sponsor-investigator, Olivier CHASSANY, University Paris 7 - Denis Diderot
- Investigators
- Olivier CHASSANY, MD, PhD, Study director, EA 7334, University Paris-Diderot, ParisPrabakar VAITTINADA AYAR, MD, Principal investigator, Hôpital Bichat-Claude BernardEnrique CASALINO, MD, Study chair, Hôpital Bichat-Claude Bernard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099915
- Sponsor's protocol ID
- AERO
- Acronym
- AERO
- Status last verified
- Apr 2021
- First submitted
- 17 Mar 2017
- Last updated
- 27 Apr 2021
- 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 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma Attack in the Emergency Department : Reasons Of This Attendance
- ClinicalTrials.gov ID
- NCT03099915
- Acronym / sponsor ID
- AERO / AERO
- Conditions
- Asthma Attack, Emergency Medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Olivier CHASSANYUniversity, hospital or other
- Collaborators
- EA 7334, Patient-Centered Outcomes Research, Bichat Hospital, Beaujon Hospital
- Study start
- 17 Mar 2017 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 4 Apr 2017 (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.
Objective: Identify modifiable factors that may affect asthma control and the use of emergency room to define customized interventions for the management of asthma prior to emergency room.
Emergency department attendance is always a sign of poor balance or control of asthma. In spite of a decrease in the number of deaths that has been halved in 20 years and hospitalization due to asthmatic disease, the use of emergency center for this disease has not decreased. We now know that the passage through emergencies and hospitalization for aggravation of asthma is in itself a factor of mortality. Acting on the determinants of poor balance or control of asthma is essential to further reduce the mortality and morbidity of asthma.
Detailed description
There is two parts in this study:
Part 1 - Qualitative study by individual interviews until data saturation (although about ten patients should be enough to capture the concepts of interest) on the factors that induce an imbalance of asthma (based on the GINA (Global Initiative for Asthma) report whose criteria are validated).
An interview guide will be written to systematically address all aspects related to asthma control.
In agreement with the patient the interview will be recorded, and the verbatim will be transcribed and coded using a software (Nvivo version 10).
Preparation of a questionnaire
A questionnaire will be developed from:
- analysis of patient verbatim
- other data: GINA criteria, psychological criteria (psychological distress is assessed by the 12-item general health questionnaire (GHQ-12) which is valid psychometric tools in French) and social criteria.
Part 2-Observational cohort qualitative study. The questionnaire thus prepared will be placed in the patient file upon admission. As soon as possible it will be filled by the patient after improvement of his condition and collected by the doctor or nurse who took care of the patient.
To obtain sufficient power to demonstrate significant associations, and assuming that 15 variables are taken into account in a multivariate model and based on the recommendations of 10 subjects per variable, 150 patients are required.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults visiting emergency department for asthma attack
Key inclusion criteria (7 listed)
- Age> 18 years
- Ambulatory patient, visiting one of these centers
- Diagnosis of asthma already evolving for more than 6 months
- Prescription of treatment for more than 3 months
- Patient who can read and write French
Key exclusion criteria (3 listed)
- Patients with other etiology that may explain their dyspnea: heart failure, chronic obstructive pulmonary disease , pneumopathy
- Patients with a social background that is not compatible with the study: a patient who does not speak French, is homeless or does not have a telephone number
- Inpatients
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 |
|---|---|---|
| completion of self-reported questionnairesSingle completion: Participants will have to complete self-reported questionnaires based on gina criteria and 12-item general health questionnaire | Other | – |
Primary outcome
Poor observance of GINA criteria
Time frame: Less than 24 hours: the outcome measure will be assessed the visiting day at emergency room, when the asthma attack will be solved, before discharge from hospital
Explanation of Asthma imbalance by poor observance and knowledge of GINA global strategy for asthma management and prevention criteria.
1 secondary outcome
GHQ-12 Psychometric tool
Time frame: Less than 24 hours: the outcome measure will be assessed the visiting day at emergency room, when the asthma attack will be solved, before discharge from hospital
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 27 Apr 2021.
- 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.
Olivier CHASSANY, MD, PhD study director
EA 7334, University Paris-Diderot, Paris
Prabakar VAITTINADA AYAR, MD principal investigator
Hôpital Bichat-Claude Bernard
Enrique CASALINO, MD study chair
Hôpital Bichat-Claude Bernard
2 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 Attack and Emergency Medicine, run by Olivier CHASSANY at 2 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 7 inclusion and 3 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 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
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?
Poor observance of GINA criteria (time frame: Less than 24 hours: the outcome measure will be assessed the visiting day at emergency room, when the asthma attack will be solved, before discharge from hospital). 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 27 Apr 2021.