NCT04010253Completed
Impact of Bronchial Drainage Technique by the Medical Device Simeox® on Respiratory Function and Symptoms in Adult Patients With Cystic Fibrosis
Impact of Bronchial Drainage by the Medical Device Simeox® on Function and Respiratory Symptoms Compared to Manual Autogenous Drainage Physiotherapy in Adult Cystic Fibrosis Patients
Source: ClinicalTrials.gov · Last updated 18 Mar 2026
Brief summary (registry, in English)
The main objective of the study is to evaluate the short-term effects of the airway clearance technique by the medical device Simeox (Physio Assist, France) versus Autogenic Drainage, on the pulmonary function of adult patients with stable cystic fibrosis. To analyse these effects, the investigators used forced oscillation technique measured by TremoFlo™ C-100 Airwave Oscillometry System™ (THORASYS Thoracic Medical Systems Inc. Montreal, Quebec, Canada) with an evaluation of the perceived clinical benefits.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 31 (actual)
- First submitted
- 3 Jul 2019
- Start date
- 30 Sept 2019
- Primary completion date
- 13 Dec 2023
- Lead sponsor
- Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
- Diseases
- Cystic fibrosis
- NCT number
- NCT04010253
What you commit to
- Study type: Interventional
- Participants enrolled: 31
- From 30 Sept 2019 to the primary completion date, 13 Dec 2023
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient registered on the transplant list
- Patient using Simeox more than twice a week during physiotherapy sessions, not wanting a washout period of 7 days before inclusion
Other illness
- Cardiovascular disorders, electrocardiogram (ECG) parameters or clinically significant respiratory (non-cystic fibrosis) conditions
Other
- Uncontrolled asthma
- Pneumothorax \<6 weeks
- Recent severe hemoptysis \<6 weeks
- Exacerbation within 4 weeks (3 months if hospitalization) before screening
- Patients unable to perform measurements of ROF, spirometry, plethysmography.
- Any contraindication to manual or instrumental physiotherapy.
- Pregnancy, breastfeeding.
- Patient under tutorship or curatorship
- No affiliation to the French social security
- Patient using Simeox at home
- Patient under Trikafta for less than 6 weeks.
Who the study is looking for
- Diagnosis of cystic fibrosis confirmed
- Age ≥18 years
- 30% \<FEV1 \<70% predicted
- Presence of bronchial congestion reported by the patient or the investigator
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CH Amiens Coordinator of this site? Confirm its status | Amiens | France | Unknown status |
| Hôpital la Bocage CHRU de Dijon Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| CHRU Lille - Hopital Calmette Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| GH Sud - Hospices Civils de Lyon Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| CH Nice Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| Soins de Suite Nutritionnels et Respiratoires -Fondation IDLYS Coordinator of this site? Confirm its status | Roscoff | France | Unknown status |
| CHU de Rouen Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| Hopital Larrey Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.