AsthmaDIFFAsthmeNCT05185375
Qualitative Assessment of Patients Suffering From Difficult Asthma
An observational study of Asthma, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Asthma is a chronic inflammatory disease, resulting from environmental, genetic and immunological factors. This is a triad specific to the diseases of the 21st century, linked to our environment, which the investigators thought were perfectly characterized and stable and which presents us with new challenges in their… Read more about this study
- Who is it for?
- Ages 5 to 99 years
- Conditions the study is for
- Asthma
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2021to 1 Apr 2022
- 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 5 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients consulting in the Respiratory Diseases outpatients Unit of the Arnaud de Villeneuve Hospital with a diagnosis of difficult-to-treat asthma
Who may be able to join
- Patients assessed for difficult asthma, from December 2015 to November 2020, at the University Hospital of Montpellier
- Patients aged from 5 to 99 years
Who cannot join
- Patients not affiliated to French Social Security
- Patients not capable of understanding French
- Patients who don't have a diagnosis of difficult asthma
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34295
Davide CAIMMI, MD, 467336112 ext. 33, davide.caimmi@gmail.com
Pascal DEMOLY
About this study
Official title: Qualitative Analysis of Patients' Medical Records, to Understand the Reasons of the Difficulty in Controlling Asthma, in Difficult Forms
Asthma is a chronic inflammatory disease, resulting from environmental, genetic and immunological factors. This is a triad specific to the diseases of the 21st century, linked to our environment, which the investigators thought were perfectly characterized and stable and which presents us with new challenges in their management. Our environment has not stopped changing over the past 30 years, so has our way of life and our way of working. The early detection of asthma and the initiation of an adequate therapy are most often carried out by primary care physicians, such as the general practitioner and the general pediatrician. These practitioners find themselves confronted with the medical complexity of asthma which essentially resides in the management of severe forms of asthma, defined by the high therapeutic charge needed to obtain a good control of the disease and, sometimes, in the management of difficult asthma which is an uncontrolled asthma independently of the patients' compliance and of the prescribed therapies. While general practitioners refer many cases of asthma to hospital experts, the investigators wanted to address the issue of difficult asthma, the management of which is less codified.
The main objective of this work is to identify, by a qualitative analysis of medical records, the profiles of patients referred for difficult asthma in a tertiary hospital in order, secondly, to target individual characteristics or subgroups on which therapeutic actions could be implemented, and to provide educational support for doctors.
- Conditions
- Asthma
- Keywords
- Severe, difficult-to-treat asthma, Difficult Asthma, Diagnosis, Comorbidities, Treatment, Allergy, Compliance
- Medical subject headings
- Asthma, Disease, Hypersensitivity, Patient Compliance
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative analysis of the medical records
Qualitative analysis of the medical records from patients addressed to a tertiary hospital for difficult asthma
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Oct 2021
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Apr 2022 (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.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Davide CAIMMI, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185375
- Sponsor's protocol ID
- RECHMPL21_0727
- Acronym
- DIFFAsthme
- Status last verified
- Dec 2021
- First submitted
- 22 Dec 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Analysis of Patients' Medical Records, to Understand the Reasons of the Difficulty in Controlling Asthma, in Difficult Forms
- ClinicalTrials.gov ID
- NCT05185375
- Acronym / sponsor ID
- DIFFAsthme / RECHMPL21_0727
- Conditions
- Asthma
- Keywords
- Severe, difficult-to-treat asthma, Difficult Asthma, Diagnosis, Comorbidities, Treatment, Allergy, Compliance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 11 Jan 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 inflammatory disease, resulting from environmental, genetic and immunological factors. This is a triad specific to the diseases of the 21st century, linked to our environment, which the investigators thought were perfectly characterized and stable and which presents us with new challenges in their management. Our environment has not stopped changing over the past 30 years, so has our way of life and our way of working. The early detection of asthma and the initiation of an adequate therapy are most often carried out by primary care physicians, such as the general practitioner and the general pediatrician. These practitioners find themselves confronted with the medical complexity of asthma which essentially resides in the management of severe forms of asthma, defined by the high therapeutic charge needed to obtain a good control of the disease and, sometimes, in the management of difficult asthma which is an uncontrolled asthma independently of the patients' compliance and of the prescribed therapies. While general practitioners refer many cases of asthma to hospital experts, the investigators wanted to address the issue of difficult asthma, the management of which is less codified.
The main objective of this work is to identify, by a qualitative analysis of medical records, the profiles of patients referred for difficult asthma in a tertiary hospital in order, secondly, to target individual characteristics or subgroups on which therapeutic actions could be implemented, and to provide educational support for doctors.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 5 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients consulting in the Respiratory Diseases outpatients Unit of the Arnaud de Villeneuve Hospital with a diagnosis of difficult-to-treat asthma
Key inclusion criteria (2 listed)
- Patients assessed for difficult asthma, from December 2015 to November 2020, at the University Hospital of Montpellier
- Patients aged from 5 to 99 years
Key exclusion criteria (3 listed)
- Patients not affiliated to French Social Security
- Patients not capable of understanding French
- Patients who don't have a diagnosis of difficult asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Qualitative analysis of the medical records
Time frame: day 1
Qualitative analysis of the medical records from patients addressed to a tertiary hospital for difficult asthma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: Undecided. NC
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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.
Davide CAIMMI principal investigator
University Hospital, Montpellier
1 site 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, Montpellier at 1 site 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 2 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: status not confirmed, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Davide CAIMMI, MD, PhD (467336112 ext. 33, davide.caimmi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative analysis of the medical records (time frame: day 1). 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 11 Jan 2022.