NCT05185375

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2021

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

January 11, 2022

Status Verified

December 1, 2021

Enrollment Period

3 months

First QC Date

December 22, 2021

Last Update Submit

December 22, 2021

Conditions

Keywords

Severe, difficult-to-treat asthmaDifficult AsthmaDiagnosisComorbiditiesTreatmentAllergyCompliance

Outcome Measures

Primary Outcomes (1)

  • Qualitative analysis of the medical records

    Qualitative analysis of the medical records from patients addressed to a tertiary hospital for difficult asthma

    day 1

Eligibility Criteria

Age5 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients consulting in the Respiratory Diseases outpatients Unit of the Arnaud de Villeneuve Hospital with a diagnosis of difficult-to-treat asthma

You may qualify if:

  • Patients assessed for difficult asthma, from December 2015 to November 2020, at the University Hospital of Montpellier
  • Patients aged from 5 to 99 years

You may not qualify if:

  • Patients not affiliated to French Social Security
  • Patients not capable of understanding French
  • Patients who don't have a diagnosis of difficult asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

AsthmaDiseaseHypersensitivityPatient Compliance

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Davide CAIMMI

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Davide CAIMMI, MD, PhD

CONTACT

Pascal DEMOLY, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2021

First Posted

January 11, 2022

Study Start

October 1, 2021

Primary Completion

January 1, 2022

Study Completion

April 1, 2022

Last Updated

January 11, 2022

Record last verified: 2021-12

Locations