BronchiectasisIMPACTNCT07443124
Simeox 200 US Study
A study testing Intermittent intrapulmonary deflation in people with Bronchiectasis and Mucus; Plug, run by Inogen Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Bronchiectasis, Mucus; Plug
- What is being tested?
- Intermittent intrapulmonary deflation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2026to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of bronchiectasis confirmed by computed chest tomography (CT chest) performed within the prior 36 months
- Persistent productive cough for which daily airway clearance therapy is prescribed.
- Daily sputum production estimated at > 1 tsp or 5 ml
- Clinically stable on medical regimen with no pulmonary exacerbation in the past 4 weeks prior to study enrolment
- Subject able to sign informed consent
Who cannot join
- Inability to cough forcefully and independently, as determined by the clinician
- Ventilatory assistance with endotracheal tube, tracheostomy tube, or mask (not including nocturnal CPAP)
- Neuromuscular disease with muscle respiratory weakness
- Severe restrictive lung disease defined as Forced Vital Capacity (FVC) <60% of predicted
- Unstable cardiac disease (e.g. major cardiac arrhythmia, unstable heart failure, heart attack, unstable angina)
- Hemodynamic instability, as determined by the clinician
Show all 16Show fewer
- Airway at risk for aspiration, as determined by the clinician
- Uncontrolled gastroesophageal reflux disease (GERD) as determined by the clinician
- Upper airway surgery in the prior 3 months
- Cardiothoracic surgery, including esophageal surgery, in the prior 6 months
- Anticipated hospitalization within the next 2 weeks
- History of pneumothorax within the prior 6 months
- History of haemoptysis treated with embolization within the prior 12 months
- Inability to use airway clearance therapy as directed
- Unable or unwilling to complete study visits or provide follow-up data as required per the study protocol
- Pregnant or lactating female
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chief Medical Officer contact
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
Patrick A Flume, MD, xxx-xxx-xxxx
About this study
Official title: 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:
- 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.
- 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.
- Home Use : Participants will use the device at home twice daily for 2 weeks, recording their usage and symptoms in a daily electronic diary.
- Final Clinic Visit (V2): Participants will return for a final clinic visit for repeat assessments.
- Follow-up Phone Call (14 days after V2): Participants will receive a follow-up phone call to assess ongoing symptoms and health status.
Read the 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.
- Conditions
- Bronchiectasis, Mucus; Plug
- Being tested
- Intermittent intrapulmonary deflation
- Keywords
- Bronchiectasis, Mucus hypersecretion, Airway clearance technique, Bronchial drainage
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent intrapulmonary deflationDevice
Two treatment sessions daily for two weeks
| Study group | Role | What they receive |
|---|---|---|
| Simeox 200 | Experimental | Simeox 200 airway clearance device Receives: Device: Intermittent intrapulmonary deflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the first training session to the last, and up to one hour following each treatment session the day of training device visit.
Secondary outcomes (11)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: From the first day of device use at home to the 14 days of home treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study startFeb 2026 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inogen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick A Flume, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443124
- Sponsor's protocol ID
- SIM200-NCFB-1001
- Acronym
- IMPACT
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Plan has not been decided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Effects of Simeox 200 Airway Clearance Device in Bronchiectasis Patients With Chronic Mucus Hypersecretion
- ClinicalTrials.gov ID
- NCT07443124
- Acronym / sponsor ID
- IMPACT / SIM200-NCFB-1001
- Conditions
- Bronchiectasis, Mucus; Plug
- Keywords
- Bronchiectasis, Mucus hypersecretion, Airway clearance technique, Bronchial drainage
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Inogen Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2026 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- Home Use : Participants will use the device at home twice daily for 2 weeks, recording their usage and symptoms in a daily electronic diary.
- Final Clinic Visit (V2): Participants will return for a final clinic visit for repeat assessments.
- Follow-up Phone Call (14 days after V2): Participants will receive a follow-up phone call to assess ongoing symptoms and health status.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simeox 200 | Experimental | Device: Intermittent intrapulmonary deflationSimeox 200 airway clearance device |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of bronchiectasis confirmed by computed chest tomography (CT chest) performed within the prior 36 months
- Persistent productive cough for which daily airway clearance therapy is prescribed.
- Daily sputum production estimated at > 1 tsp or 5 ml
- Clinically stable on medical regimen with no pulmonary exacerbation in the past 4 weeks prior to study enrolment
- Subject able to sign informed consent
Key exclusion criteria (16 listed)
- Inability to cough forcefully and independently, as determined by the clinician
- Ventilatory assistance with endotracheal tube, tracheostomy tube, or mask (not including nocturnal CPAP)
- Neuromuscular disease with muscle respiratory weakness
- Severe restrictive lung disease defined as Forced Vital Capacity (FVC) <60% of predicted
- Unstable cardiac disease (e.g. major cardiac arrhythmia, unstable heart failure, heart attack, unstable angina)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent intrapulmonary deflationTwo treatment sessions daily for two weeks | Device | Simeox 200 |
Primary outcome
Wet sputum weight collected with Simeox 200 during device training visit
Time frame: From the first training session to the last, and up to one hour following each treatment session the day of training device 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.
11 secondary outcomes
Change from baseline in Forced Expiratory Volume in One seconde (FEV1) at the final study visit (V2) after 14 days of treatment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: At the final study visit at 15 days
Adherence to the device over the entire period of home use
Time frame: From the first day of device use at home to the 14 days of home treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: Undecided. Plan has not been decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chief Medical Officer contact
Patrick A Flume, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent intrapulmonary deflation in people with Bronchiectasis and Mucus; Plug, run by Inogen Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roxanna Edwards (xxx-xxx-xxxx, redwards@inogen.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wet sputum weight collected with Simeox 200 during device training visit (time frame: From the first training session to the last, and up to one hour following each treatment session the day of training device visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.