COMEGE: Analysis of Inhaled Corticoid Prescriptions in General Medicine

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Completed

CT.gov ID

NCT03179826

Collaborator

(none)

Enrollment

Locations

17.6

Actual Duration (Months)

Patients Per Site

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Chronic obstructive pulmonary disease (COPD) and asthma are frequent and disabling pathologies. The general practitioner is often at the front line vis-a-vis screening, diagnosis and treatment of these pathologies. There are currently many treatments available, in particular inhaled corticosteroids, and although the recommendations for management appear to be well codified in theory, the adaptation of drug therapy remains complex in general practice.

The prescription of inhaled corticosteroids, often initiated during a general medicine consultation, is not simple. The aim of this study is to analyze the relevance of the prescription of inhaled corticosteroids in primary care and to identify the criteria necessary for the prescription of inhaled corticosteroids available in general practice.

The main objective of our study is to evaluate the rate of consultations where all the elements required for guiding the prescription of an inhaled corticoid are available.

The secondary objectives are:

Identify other factors associated with decision-making
Identify the causes of inhaled corticosteroid stopping (de-prescription)

Condition or Disease	Intervention/Treatment	Phase
Asthma Chronic Obstructive Pulmonary Disease

Study Design

Study Type:

Observational

Actual Enrollment :

80 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Analysis of Inhaled Corticoid Prescriptions in General Medicine

Actual Study Start Date :

Jul 13, 2017

Actual Primary Completion Date :

Jul 1, 2018

Actual Study Completion Date :

Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Study population Adults consulting with one of the participating general practitioners and requiring long term inhaled corticoids and monitoring.

Outcome Measures

Primary Outcome Measures

Presence of all factors justifying the prescription of inhaled cortcoids [Day 0 (transversal study)]
The presence (yes/no) of all factors justifying the prescription of inhaled cortcoids as described in the associated market authorization.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient with short-term inhaled corticosteroid therapy
Informed and not opposed to participate in this research

Exclusion Criteria:

Patient under judicial or legal protection
Adults under any kind of guardianship -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cabinet de médecine générale	Clapiers		France	34830
2	Cabinet de médecine générale	St Martin de Londres		France	34380

Sponsors and Collaborators

University Hospital, Montpellier

Investigators

Study Director: Arnaud Bourdin, MD, PhD, Montpellier University Hospitals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Montpellier

ClinicalTrials.gov Identifier:

NCT03179826

Other Study ID Numbers:

RECHMPL17-0152
2017-A01230-53

First Posted:

Jun 7, 2017

Last Update Posted:

Apr 18, 2019

Last Verified:

Apr 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Apr 18, 2019