NCT04010253

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 8, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

September 30, 2019

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2023

Completed
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

4.2 years

First QC Date

July 3, 2019

Last Update Submit

March 16, 2026

Conditions

Cystic Fibrosis

Keywords

Cystic FibrosisPhysiotherapyDrainage

Outcome Measures

Primary Outcomes (1)

  • Low frequency resistance R5

    Comparison of variations V4 and V8 sessions (pre and post airway clearance session)

    1 month

Secondary Outcomes (4)

  • Comparison of the impact of Simeox® bronchial drainage compared to autogenous drainage on respiratory symptoms: dyspnea, congestion and fatigue

    1 month

  • Evaluation of the distal and / or proximal decluttering by the two techniques, according to the improvement profile of the forced oscillations

    1 month

  • Evaluation of the impact of Simeox® bronchial drainage vs autogenous drainage by spirometry and plethysmography (distension and resistance)

    1 month

  • Evaluation of correlations between clinical benefit and changes in functional respiratory investigations (forced oscillations, spirometry, plethysmography)

    1 month

Study Arms (2)

SIMEOX

EXPERIMENTAL
Other: Autogenic drainage

Autogenic Drainage

ACTIVE COMPARATOR
Device: SIMEOX

Interventions

SIMEOXDEVICE

Instrumental airway clearance by the medical device SIMEOX

Autogenic Drainage
Autogenic drainageOTHER

Manual aiway clearance by autogenic drainage

SIMEOX

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of cystic fibrosis confirmed
  • Age ≥18 years
  • % \<FEV1 \<70% predicted
  • Presence of bronchial congestion reported by the patient or the investigator

You may not qualify if:

  • Uncontrolled asthma
  • Pneumothorax \<6 weeks
  • Recent severe hemoptysis \<6 weeks
  • Patient registered on the transplant list
  • Exacerbation within 4 weeks (3 months if hospitalization) before screening
  • Cardiovascular disorders, electrocardiogram (ECG) parameters or clinically significant respiratory (non-cystic fibrosis) conditions
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

CH Amiens

Amiens, France

Location

Hôpital la Bocage CHRU de Dijon

Dijon, France

Location

CHRU Lille - Hopital Calmette

Lille, France

Location

GH Sud - Hospices Civils de Lyon

Lyon, France

Location

CH Nice

Nice, France

Location

Soins de Suite Nutritionnels et Respiratoires -Fondation IDLYS

Roscoff, France

Location

CHU de Rouen

Rouen, France

Location

Hopital Larrey

Toulouse, France

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Thierry PEREZ, MD

    CHRU LILLE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2019

First Posted

July 8, 2019

Study Start

September 30, 2019

Primary Completion

December 13, 2023

Study Completion

December 13, 2023

Last Updated

March 18, 2026

Record last verified: 2026-03

Locations

FR(8)