Cystic FibrosisCOMURA MUCOBSNCT02832479
Costs of Care and Adherence to Treatment for Cystic Fibrosis
An observational study of Cystic Fibrosis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Evolution of medical care for patients with cystic fibrosis appeared in recent years: prolongation of life expectancy with consequently increased comorbidities and the use of lung transplantation, systematic neonatal screening of new born since 2002, prescription of expensive new molecules or new presentation. Read more about this study
- Who is it for?
- Ages Up to 99 years
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2014to Feb 2016
- 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 Up to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with cystic fibrosis living in Rhône-Alpes region
Who may be able to join
- Patients with cystic fibrosis,
- Followed by one of the cystic fibrosis center of the Rhône-Alpes region (pediatric and adult of Lyon and Grenoble)
- Affiliated to the general scheme of health insurance,
- And domiciled in the Rhône-Alpes region.
Who cannot join
- Transplanted patients
Trial locations and contacts
1 site in 1 country.
France1 site
Hospices civils de Lyon, centre hospitalier lyon Sud
Pierre-Bénite, 69310
About this study
Official title: Costs of Care and Adherence to Treatment for Cystic Fibrosis.
Evolution of medical care for patients with cystic fibrosis appeared in recent years: prolongation of life expectancy with consequently increased comorbidities and the use of lung transplantation, systematic neonatal screening of new born since 2002, prescription of expensive new molecules or new presentation. This evolution justifies to realize an update of statistics of costs of care and to assess adherence to treatment
- Conditions
- Cystic Fibrosis
- Medical subject headings
- Cystic Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment cost
Measured: 12 months
Secondary outcomes (1)
adherence rate for chronic treatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startOct 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832479
- Sponsor's protocol ID
- 69HCL15_0698
- Acronym
- COMURA MUCOBS
- Status last verified
- Jun 2016
- First submitted
- 21 Jun 2016
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Costs of Care and Adherence to Treatment for Cystic Fibrosis.
- ClinicalTrials.gov ID
- NCT02832479
- Acronym / sponsor ID
- COMURA MUCOBS / 69HCL15_0698
- Conditions
- Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 14 Jul 2016 (estimated)
- 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.
Evolution of medical care for patients with cystic fibrosis appeared in recent years: prolongation of life expectancy with consequently increased comorbidities and the use of lung transplantation, systematic neonatal screening of new born since 2002, prescription of expensive new molecules or new presentation. This evolution justifies to realize an update of statistics of costs of care and to assess adherence to treatment
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with cystic fibrosis living in Rhône-Alpes region
Key inclusion criteria (4 listed)
- Patients with cystic fibrosis,
- Followed by one of the cystic fibrosis center of the Rhône-Alpes region (pediatric and adult of Lyon and Grenoble)
- Affiliated to the general scheme of health insurance,
- And domiciled in the Rhône-Alpes region.
Key exclusion criteria (1 listed)
- Transplanted patients
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
treatment cost
Time frame: 12 months
1 secondary outcome
adherence rate for chronic treatment
Time frame: 12 months
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 10 Aug 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cystic Fibrosis, run by Hospices Civils de Lyon 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 4 inclusion and 1 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 10 Aug 2016. 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?
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?
treatment cost (time frame: 12 months). 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 10 Aug 2016.