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Ancillary Home Airway Clearance in CF Patients ( HomeCareSIMEOX )

Study Purpose

Regular bronchial clearance is essential in patients with cystic fibrosis for their bronchial health. SIMEOX® (Physio-Assist, Aix en Provence, France) is an innovative medical device for the drainage of the bronchial tree. By changing the rheological properties of mucus, SIMEOX® helps to mobilize secretions and assists their transport to the upper airways. This technology is based on fundamental research on bronchial mucus rheology. At the present time, SIMEOX® device is mainly used over a short period at the time or after an exacerbation in healthcare structures (hospitals, physiotherapy practices, postcare, and rehabilitation units, etc…). The clinical effects observed in the short term encourages long-term autonomous use by the patients themselves. The overall objective of this study is to evaluate the efficiency and acceptability of SIMEOX® used at home by the patient himself for bronchial clearance in patients with cystic fibrosis.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 14 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - one of the 56 first patients of HOME-CARE SIMEOX study.
  • - same criteria as HOME-CARE SIMEOX study.

Exclusion Criteria:

- same criteria as HOME-CARE SIMEOX study

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04095078
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Physio-Assist
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Boubou Camara, MD
Principal Investigator Affiliation CHUGA
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

IndustryIndustry
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Cystic Fibrosis
Arms & Interventions

Arms

Experimental: SIMEOX

Use the device for 3 months in addition to usual care

No Intervention: Control

Usual care

Interventions

Device: - SIMEOX

Use without obligation, in autonomous and at home of the bronchial clearance device: SIMEOX

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Grenoble, France

Status

Recruiting

Address

Grenoble University Hospital : pneumo-pediatric department

Grenoble, , 38043

Site Contact

Isabelle PIN, MD

IPin@chu-grenoble.fr

0476747703

Grenoble, France

Status

Recruiting

Address

Grenoble University-Affiliated Hospital : Pneumology department

Grenoble, , 38043

Site Contact

Boubou Camara, MD

bcamara@chu-grenoble.fr

+33 476765846

Montpellier Hospital Center, Montpellier, France

Status

Suspended

Address

Montpellier Hospital Center

Montpellier, , 34000

Nice, France

Status

Recruiting

Address

Nice University-Affiliated Hospital : Pneumology department

Nice, , 06002

Site Contact

Sylvie Leroy, MD

l.borges@agiradom.com

0476747703

Nice, France

Status

Not yet recruiting

Address

Nice University-Affiliated Hospital : Pneumo-pediatric department

Nice, , 06200

Site Contact

Aline Joulie

joulie.a@chu-nice.fr

+33 4.92.03.05.20

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