AsthmaCOMEGENCT03179826
Analysis of Inhaled Corticoid Prescriptions in General Medicine
An observational study of Asthma and Chronic Obstructive Pulmonary Disease, run by University Hospital, Montpellier at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma, Chronic Obstructive Pulmonary Disease
- How many people
- 80 participants
- Where
- 2 sitesFrance
- Study dates
- 13 Jul 2017to 31 Dec 2018
- 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: The study population is composed of adults consulting with one of the participating general practitioners and requiring long term inhaled corticoids and monitoring.
Who may be able to join
- Patient with short-term inhaled corticosteroid therapy
- Informed and not opposed to participate in this research
Who cannot join
- Patient under judicial or legal protection
- Adults under any kind of guardianship -
Trial locations and contacts
2 sites in 1 country.
France2 sites
Cabinet de médecine générale
Clapiers, 34830
Cabinet de médecine générale
Saint-Martin-de-Londres, 34380
About this study
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.
Read more
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)
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study population | Adults consulting with one of the participating general practitioners and requiring long term inhaled corticoids and monitoring. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 (transversal study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start13 Jul 2017
- Primary completion1 Jul 2018
- Study completion31 Dec 2018
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
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud Bourdin, MD, PhD, Study director, Montpellier University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03179826
- Sponsor's protocol ID
- RECHMPL17-0152
- Other IDs
- 2017-A01230-53
- Acronym
- COMEGE
- Status last verified
- Apr 2019
- First submitted
- 6 Jun 2017
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Inhaled Corticoid Prescriptions in General Medicine
- ClinicalTrials.gov ID
- NCT03179826
- Acronym / sponsor ID
- COMEGE / RECHMPL17-0152
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 13 Jul 2017 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 7 Jun 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.
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)
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | – | –Adults consulting with one of the participating general practitioners and requiring long term inhaled corticoids and monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patient with short-term inhaled corticosteroid therapy
- Informed and not opposed to participate in this research
Key exclusion criteria (2 listed)
- Patient under judicial or legal protection
- Adults under any kind of guardianship -
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
Presence of all factors justifying the prescription of inhaled cortcoids
Time frame: Day 0 (transversal study)
The presence (yes/no) of all factors justifying the prescription of inhaled cortcoids as described in the associated market authorization.
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 18 Apr 2019.
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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.
Arnaud Bourdin, MD, PhD study director
Montpellier University Hospitals
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 and Chronic Obstructive Pulmonary Disease, run by University Hospital, Montpellier 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 2 inclusion and 2 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 18 Apr 2019. 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?
Presence of all factors justifying the prescription of inhaled cortcoids (time frame: Day 0 (transversal study)). 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 18 Apr 2019.