Simeox 200 US Study (IMPACT)

A Pilot Study to Assess the Effects of Simeox 200 Airway Clearance Device in Bronchiectasis Patients With Chronic Mucus Hypersecretion

The purpose of this single arm post-market observational study is to evaluate the short-term effectiveness of the Simeox 200 airway clearance device in improving airway clearance in adult patients aged 18 to 85 with bronchiectasis and chronic mucus hypersecretion. The study aims to establish a baseline for wet sputum weight production using the Simeox 200 device. Additionally, the study aims to assess the short-term effects of Simeox 200 on various outcomes, including lung function, respiratory symptoms, and health-related quality of life.

The study participants will undergo the following steps:

1. Baseline Visit (V0): Participants will attend a baseline visit for eligibility screening, consent, a physical exam, and baseline assessments of various relevant parameters such as lung function, SpO2, and Patient-Reported-Outcomes.
2. Treatment Sessions (V1): Participants will perform two supervised treatment sessions with the Simeox 200 device at the clinic, during which sputum will be collected and weighed.
3. Home Use : Participants will use the device at home twice daily for 2 weeks, recording their usage and symptoms in a daily electronic diary.
4. Final Clinic Visit (V2): Participants will return for a final clinic visit for repeat assessments.
5. Follow-up Phone Call (14 days after V2): Participants will receive a follow-up phone call to assess ongoing symptoms and health status.

Study Overview

• Status: Not yet recruiting
• Conditions: Bronchiectasis; Mucus; Plug
• Intervention / Treatment: Device: Intermittent intrapulmonary deflation

Detailed Description

Airway clearance techniques (ACTs) are essential for removing excess bronchial secretions and preventing airway complications. However, their effectiveness relies on patient adherence and satisfaction. Simoex 200 is a novel airway clearance device that uses intermittent negative oscillating pressure to mobilize airway secretions from different parts of the lungs to central airways, facilitating expectoration. Preliminary studies in Europe on patients with chronic muco-obstructive lung diseases have demonstrated the effectiveness and good tolerance of previous generations of the device. This pilot study will evaluate the Simeox 200 device in a home care setting for patients with bronchiectasis and excessive mucus production. The results of this study will inform a future larger-scale clinical trial.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roxanna Edwards; Phone Number: xxx-xxx-xxxx; Email: redwards@inogen.net
• Study Contact Backup: Name: Chief Medical Officer; Email: kjhaveri@inogen.net

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
      • Contact: Patrick A Flume, MD; Phone Number: xxx-xxx-xxxx

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Diagnosis of bronchiectasis confirmed by computed chest tomography (CT chest) performed within the prior 36 months
2. Persistent productive cough for which daily airway clearance therapy is prescribed.
3. Daily sputum production estimated at > 1 tsp or 5 ml
4. Clinically stable on medical regimen with no pulmonary exacerbation in the past 4 weeks prior to study enrolment
5. Subject able to sign informed consent

Exclusion Criteria:

1. Inability to cough forcefully and independently, as determined by the clinician
2. Ventilatory assistance with endotracheal tube, tracheostomy tube, or mask (not including nocturnal CPAP)
3. Neuromuscular disease with muscle respiratory weakness
4. Severe restrictive lung disease defined as Forced Vital Capacity (FVC) <60% of predicted
5. Unstable cardiac disease (e.g. major cardiac arrhythmia, unstable heart failure, heart attack, unstable angina)
6. Hemodynamic instability, as determined by the clinician
7. Airway at risk for aspiration, as determined by the clinician
8. Uncontrolled gastroesophageal reflux disease (GERD) as determined by the clinician
9. Upper airway surgery in the prior 3 months
10. Cardiothoracic surgery, including esophageal surgery, in the prior 6 months
11. Anticipated hospitalization within the next 2 weeks
12. History of pneumothorax within the prior 6 months
13. History of haemoptysis treated with embolization within the prior 12 months
14. Inability to use airway clearance therapy as directed
15. Unable or unwilling to complete study visits or provide follow-up data as required per the study protocol
16. Pregnant or lactating female

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Simeox 200; Simeox 200 airway clearance device	Device: Intermittent intrapulmonary deflation; Two treatment sessions daily for two weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wet sputum weight collected with Simeox 200 during device training visit	Patients will be instructed during device training visit (V1) to spill all sputum into a pre-weighed pot from at least two supervised sessions. Immediately after collection, all sputum will be weighed on weighing scales with an accuracy of 0.01 grams.	From the first training session to the last, and up to one hour following each treatment session the day of training device visit.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Forced Expiratory Volume in One seconde (FEV1) at the final study visit (V2) after 14 days of treatment	FEV1will be measured with a spirometer according to the ATS guidelines immediately before any procedures at the study site	From enrollment to the final study visit at 15 days
Change from baseline in Forced Vital Capacity (FVC) at the final study visit after 14 days of treatment	FVC will be measured with a spirometer according to the ATS guidelines immediately before any procedures at the study site	From enrollment to the final study visit at 15 days
Change from baseline in Forced Expiratory Flow between 25% and 75% of vital capacity (FEF25-75%) at the final study visit after 14 days of treatment	FEF25-75% will be measured with a spirometer according to the ATS guidelines immediately before any procedures at the study site	From enrollment to the final study visit at 15 days
Change from baseline in Peripheral blood oxygen saturation (SpO2) at final study visit after 14 days of treatment	SpO2 will be measured transcutaneously at rest with a fingertip pulse oximeter before lung function measurements at rest and any procedures with the device at the study site	From enrollment to the final study visit at 15 days
Change from baseline in perceived respiratory symptoms assessed with the Breathlessness, Cough and Sputum Scale (BCSS) at 7 and 14 days of treatment	BCSS is a patient-reported outcome measure that asks patients to rate the severity of the three symptoms breathing difficulty, cough, and sputum levels, each on a 5-point scale from 0 (no symptom) to 4 (highest severe symptom)	From enrollment to 7 and 14 days of treatment at home
The change from device training visit in wet sputum weight at the final study visit after 14 days of treatment	Patients will be instructed to spill all sputum into a pre-weighed pot. Immediately after collection, all sputum will be weighed on weighing scales with an accuracy of 0.01 grams.	From device training visit to the final study visit at 15 days
The change from baseline in airway-disease health status assessed by the Chronic Airway Assessement Test (CAAT) and QOL - B questionnaire at the final study visit after 14 days of treatment	The CAAT is an 8-item questionnaire designed for assessing the impact of a chronic respiratory disease such as bronchiectasis on a person's life. The questionnaire covers symptoms (such as cough, sputum, chest tightness and breathlessness) and disease impacts (including physical activity, confidence, sleep and energy) assessed each on a 6-point scale from 0 (best outcome) to 5 (worst outcome). The QOL-B on the other hand is a self-administered, patient-reported outcome measure assessing symptoms, functioning and health-related quality of life for patients bronchiectasis.	From enrollment to the final study visit at 15 days
The change from baseline in walking distance assessed with 6-minutes Walking Test (6MWT) at the final study visit after 14 days of treatment	The 6MWT is a low-intensity, submaximal exercise test used to assess aerobic capacity and endurance and oxygen saturation. 6MWT will be performed after spirometry assessment and in accordance with ATS guidelines. SpO2 will be measured transcutaneously at rest for 5 min before, during and at the end of the 6MWT. A modified Borg scale will be completed beofre and at the end of 6MWT for dyspnea and fatigability scores.	From enrollment to the final study visit at 15 days
The change from baseline in borg dyspnea and fatigue score after 6MWT compared to borg dyspnea and fatigue score after 6MWT at the final study visit after 14 days of treatment respectively.	The 6MWT is a low-intensity, submaximal exercise test used to assess aerobic capacity and endurance and oxygen saturation. 6MWT will be performed after spirometry assessment and in accordance with ATS guidelines. SpO2 will be measured transcutaneously at rest for 5 min before, during and at the end of the 6MWT. A modified Borg scale will be completed before and at the end of 6MWT for dyspnea and fatigability scores.	From enrollment to the final study visit at 15 days
The global patient satisfaction will be evaluated with Lickert scale at the final study visit after 14 days of treatment	Likert scale measures respondents' level of agreement/satisfaction or disagreement/dissatisfaction towards the treatment on the following attributes: overall / learning time / easy to handle / subjective effectiveness / treatment duration / use in autonomy. These rating scales offer 10 response options, ranging from 0 (worst outcome) to 10 (best outcome).	At the final study visit at 15 days
Adherence to the device over the entire period of home use	The patient will record adherence to Simeox 200 on a daily diary at home, noting the number of sessions per day and the duration of each session.	From the first day of device use at home to the 14 days of home treatment

Collaborators and Investigators

• Sponsor: Inogen Inc.
• Investigators: Principal Investigator: Patrick A Flume, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 19, 2026
• First Submitted That Met QC Criteria: February 24, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Bronchiectasis; Airway clearance technique; Mucus hypersecretion; Bronchial drainage
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis
• Other Study ID Numbers: SIM200-NCFB-1001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Plan has not been decided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes