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NCT02832479 Clinical Trial

Costs of Care and Adherence to Treatment for Cystic Fibrosis

Cystic Fibrosis Clinical Trial

— COMURA MUCOBS  

Official title:
Costs of Care and Adherence to Treatment for Cystic Fibrosis.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02832479
Other study ID # 69HCL15_0698
Secondary ID
Status Completed
Phase N/A
First received June 21, 2016
Last updated August 9, 2016
Start date October 2014
Est. completion date February 2016

Study information
Verified date June 2016
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority Commission Nationale de l'Inforamtique et des Libertés: 'France'France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
Study type Observational

Clinical 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. This evolution justifies to realize an update of statistics of costs of care and to assess adherence to treatment

Recruitment information / eligibility
Status Completed
Enrollment 500
Est. completion date February 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender Both
Age group N/A to 99 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- Transplanted patients

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
France Hospices civils de Lyon, centre hospitalier lyon Sud Pierre Benite

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary treatment cost 12 months No
Secondary adherence rate for chronic treatment 12 months No
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