NCT03179826

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)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

June 6, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 7, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

July 13, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

12 months

First QC Date

June 6, 2017

Last Update Submit

April 17, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Presence of all factors justifying the prescription of inhaled cortcoids

    The presence (yes/no) of all factors justifying the prescription of inhaled cortcoids as described in the associated market authorization.

    Day 0 (transversal study)

Study Arms (1)

Study population

Adults consulting with one of the participating general practitioners and requiring long term inhaled corticoids and monitoring.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population is composed of adults consulting with one of the participating general practitioners and requiring long term inhaled corticoids and monitoring.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cabinet de médecine générale

Clapiers, 34830, France

Location

Cabinet de médecine générale

Saint-Martin-de-Londres, 34380, France

Location

MeSH Terms

Conditions

AsthmaPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Arnaud Bourdin, MD, PhD

    Montpellier University Hospitals

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

June 6, 2017

First Posted

June 7, 2017

Study Start

July 13, 2017

Primary Completion

July 1, 2018

Study Completion

December 31, 2018

Last Updated

April 18, 2019

Record last verified: 2019-04

Locations