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Could heat pulses in the airways quiet a Smoker's cough?

NCT ID NCT05641207

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This trial tests a device called RheOx that delivers controlled heat pulses to the airways to reduce excess mucus-producing cells, which are a hallmark of chronic bronchitis. The study enrolls adults aged 35 to 80 with moderate-to-severe COPD and chronic bronchitis symptoms. Participants receive two treatment sessions, one for each lung, about a month apart. The goal is to see if this procedure can improve symptoms like cough and mucus, as measured by standard questionnaires over 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RheOx bronchial rheoplasty system (a device that delivers controlled heat pulses to the airways to reduce mucus-producing cells)
What this could lead to
If it works, this could offer a new way to ease chronic cough and mucus in COPD patients who have chronic bronchitis, improving their daily breathing and quality of life.
What could go wrong
This is an early, small study (40 people) without a comparison group, so results may not be conclusive. The procedure involves two sessions of airway treatment, which carries risks like temporary worsening of symptoms or infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

40 people

The number who actually took part.

Started

May 2023

Finished

Jun 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

35 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subject's age is ≥35 years and ≤80 years 2. Subject has chronic bronchitis, defined as productive cough for three months in each of two successive years, whereas other causes of productive cough have been ruled out. 3. Subject has a CAT score ≥ 10. 4. Subject's responses to the first two questions of the CAT questionnaire sum to ≥ 7 points or the sum is 6 points and the subject's total CAT score is \> 20 points. 5. Subject has a SGRQ score ≥ 25. 6. Subject has post -bronchodilator FEV1/FVC \< 0.7. 7. Subject has post-bronchodilator FEV1 percent predicted of ≥ 30%. 8. Subject is receiving guideline directed pharmacotherapy which includes one or more long-acting bronchodilator (LAMA, LABA) with or without an inhaled corticosteroid for at least 8 weeks prior to enrollment. 9. Subject has a cigarette smoking history of at least ten pack years (packs per day x years of smoking), and has had quit smoking for at least 6 months before enrollment; 10. In the opinion of the investigator, subject is able to undergo 2 bronchoscopies under general anesthesia and is able to adhere to the study follow-up schedule. Subject has provided informed consent. Exclusion Criteria: 1. Subject has known unresolved lower respiratory tract infection (e.g., pneumonia, mycobacterium avium-intracellulare infection (MAI), fungus, tuberculosis). 2. Subject has a pulmonary nodule or cavity . In the judgement of the investigator, the subject may require intervention during the course of the study. 3. Subject has clinically significant bronchiectasis influencing the subject's clinical symptoms of cough and phlegm. 4. Subject has severe other lung diseases (including interstitial pneumonia, lung fibrosis, pulmonary fibrosis with emphysema, atelectasis, unresolved lung Cancer, giant pulmonary bullae); 5. Subject has asthma based on Global Initiative for Asthma (GINA) criteria. 6. Subject has had prior severe respiratory infection with SARS-CoV-2 (COVID-19) that required ICU support with non-invasive and/or invasive mechanical ventilation. 7. Subject had prior lung surgery, such as lung transplant, LVRS, lobectomy, lung implant/prosthesis, metal airway stent, valves, coils or bullectomy. Prior pneumothorax without lung resection, pleural procedures without surgery, or segmentectomy are acceptable 8. Subject has a history of arrhythmia within past two years which includes tachy-atrial arrhythmias, any ventricular tachy-arrhythmias, grade II, II or III AV transmission history of conduction blockor, sinus bradycardia with heart rate less than 45 beats per minute. 9. Subject is on anticoagulation for cardiovascular indications and, at the discretion of the investigator, is unable to have anticoagulants (i.e., Aspirin, Plavix, Coumadin) withheld for the bronchoscopy procedure per institution's standard of care. \* If the anticoagulants withheld is clinically acceptable, five to seven days withheld before enrollment is advised. 10. Subject has other serious diseases (e.g. congestive heart failure, cardiomyopathy, or myocardial infarction in the past year, renal failure, liver failure, cerebrovascular accident within the past 6 months, uncontrolled diabetes (HbA1c \>8%), uncontrolled hypertension (diastolic BP \>100mmHg) or autoimmune disease requiring treatment with immunosuppressant medications or a disease requiring chemotherapy). 11. Subject has uncontrolled gastroesophageal reflux disease(GERD)that indicated by the common symptoms and signs like stomach burning, acid reflux, regurgitation of partial digested food or acid into throat. 12. Subject has any implantable electronic device (e.g., pacemaker, cardioverter defibrillator, neuro-stimulation devices). 13. Subject has known airway colonization with resistant organisms, such as pseudomonas, methicillin-resistant Staphylococcus aureus (MRSA), Burkholderia cepacia complex, Mycobacterium Tuberculosis (MTB), Mycobacterium abscessus mucor or significant fungus. 14. Subject has known severe pulmonary hypertension. 15. Subject has a known sensitivity to medication required to perform bronchoscopy (i.e., lidocaine, atropine, benzodiazepines, Propofol). 16. Subject has known allergy to nickel. 17. Subject is receiving any traditional Chines herbs for cough or phlegm. \* mucolytics may be recommended by institute clinical practice, carbocysteine, oral or inhaled N-acetylcysteine, Eucalyptol and ambroxol hydrochloride are suggested. \* The treatrment of this study is to ablate bronchial mucosa by airway intervention, then mucosa epithelium is repaired. The effect of inhalation on the repair of airway mucosal epithelium is unknown. Therefore, it is not recommended to oral or inhaled N-acetylcysteine during treatment and follow-up. 18. Subject has a steroid-dependent condition requiring \>10 mg of oral corticosteroid (e.g. prednisone or equivalence.) per day. 19. Subject is unable to walk over 225 meters in 6 minutes. 20. Subject has emphysema of greater than or equal to 35% (low attenuation area≤ -950HU) as determined by HRCT quantitative analysis. 21. Subject is pregnant, nursing, or planning to get pregnant during study duration. 22. Subject has HIV infection or active syphilis infection; 23. Subject is currently participating in another clinical study involving an investigational product. 24. Subject is not suitable for bronchoscopy by the judgement of investigator.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, China

  • Peking University First Hospital

    Beijing, Beijing Municipality, China

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hanzhou, Zhejiang, China

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, China

  • The Tenth People's Hospital of Shanghai

    Shanghai, Shanghai Municipality, China

  • Xiangya Hospital of Central South University

    Changsha, Hunan, China

  • Xinqiao Hospital, Army Medical University

    Chongqing, Chongqing Municipality, China

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