Last reviewed · How we verify
NCT04010253: MUCOSIM
Impact of Bronchial Drainage Technique by the Medical Device Simeox® on Respiratory Function and Symptoms in Adult Patients With Cystic Fibrosis
NA trial testing SIMEOX in Cystic Fibrosis in 31 participants. Completed in 13 December 2023.
13 December 2023
Quick facts
| Lead sponsor | Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 31 |
| Start date | 30 September 2019 |
| Primary completion | 13 December 2023 |
| Estimated completion | 13 December 2023 |
| Sites | 8 locations across France |
Drugs / interventions tested
- SIMEOX
- Autogenic drainage
Conditions studied
- Cystic Fibrosis — all drugs for Cystic Fibrosis →
Sponsor
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
Who can join
18 and older, any sex, with Cystic Fibrosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Autogenic drainage for airway clearance in cystic fibrosis.
Burnham P, Stanford G, Stewart R. · · 2021 · cited 14× · PMID 34910295 · DOI 10.1002/14651858.cd009595.pub3 -
Airway clearance techniques compared to no airway clearance techniques for cystic fibrosis.
Warnock L, Gates A. · · 2023 · cited 12× · PMID 37042825 · DOI 10.1002/14651858.cd001401.pub4
Verify or expand the search:
- PubMed search for NCT04010253
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of SIMEOX
Trials testing the same drug.
- NCT04096664 — Home Airway Clearance in CF Patients · NA · completed
- NCT04095078 — Ancillary Home Airway Clearance in CF Patients ( HomeCareSIMEOX ) · NA · completed
- NCT04157972 — Effects of SIMEOX on Static Hyperinflation in Patients With COPD · NA · completed
- NCT04150601 — Effects of SIMEOX on Flow and Volume in Healthy Subjects and Patients With COPD · NA · completed
- NCT03655860 — Effects of SIMEOX on Flow and Volume · NA · withdrawn
Other recruiting trials for Cystic Fibrosis
Currently open trials in the same condition.
- NCT07437105 — Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-272 in Healthy Participants · Phase 1 · recruiting
- NCT07283770 — Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-581 in Healthy Participants · Phase 1 · recruiting
- NCT07274631 — A Cohort for Inflammatory Respiratory Diseases: From Phenotyping to Personalised Medicine · recruiting
- NCT06810167 — Assessing Tenapanor as a Treatment of CF-related Constipation. · Phase 3 · recruiting
- NCT06962852 — A Long-term Study to Monitor the Health Status of People With Cystic Fibrosis Who Took Part in a Previous Study With BI · Phase 1, PHASE2 · active not recruiting
Other Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche trials
Trials by the same sponsor.
- NCT05815420 — Home Tele-Monitoring of Non-Invasive Ventilation in COPD Patients in France · unknown
- NCT03395418 — Evaluation of the Right Use of Inhaled Therapeutics · completed
- NCT03053011 — Evaluation of the Awakening Capability by a Vibrating Bracelet (BRASSARD) · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04010253 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
- Last refreshed: 18 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04010253.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing