COPD Trial, Recruiting NCT07068438 Sponsor: Suzhou Hengruihongyuan Medical Technology Co. LTD Condition: COPD
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COPD Trial, Recruiting

NCT07068438
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are aged between 35 and 80 years old.
  • People who have chronic bronchitis, meaning they have had a mucus-producing cough for at least three months a year, for two years in a row, and other causes of that cough have been ruled out.
  • People whose symptom burden score on a standard lung disease questionnaire (called the CAT) is 10 or higher.
  • People whose quality-of-life score on another standard lung questionnaire (called the SGRQ) is 25 or higher.
  • People whose answers to the first two CAT questions add up to 7 or more points, or add up to 6 points when their total CAT score is above 20 (confirm with trial site).
  • People whose breathing test results show a specific pattern of airflow limitation (FEV1/FVC ratio below 0.70).
  • People whose lung function, measured after using a bronchodilator (airway-opening medication), is at least 30% of what would normally be expected for someone of their age and size.
  • People who have been using at least one long-acting inhaler medication (a type that keeps the airways open) for at least 8 weeks before joining the trial — with or without an inhaled steroid — unless they have tried this type of medication in the past year without meaningful benefit or had a bad reaction to it.
  • People who, in the lead doctor's opinion, are well enough to undergo two bronchoscopy procedures under general anaesthetic and are able to attend all scheduled follow-up appointments.
  • People who have signed an informed consent form, or whose legal representative has done so on their behalf.

Who may not be able to join:

  • People who have an active, unresolved lung infection, such as pneumonia, tuberculosis, or a fungal infection.
  • People who need more than 10 mg of oral steroid tablets daily to manage another health condition.
  • People who have an implanted electronic device (such as a pacemaker or defibrillator) that cannot be switched off during the procedure.
  • People who have had certain serious heart rhythm problems within the past two years, or a resting heart rate below 45 beats per minute — unless that condition has been treated and their heart rhythm is normal during the screening period.
  • People who have lung cancer.
  • People who have a spot or cavity on their lung that the lead doctor believes may need further treatment during the course of the study.
  • People who have previously had lung surgery, including lung transplant, lung volume reduction surgery, removal of part of a lung, a lung implant or prosthesis, metal airway stents, valves, coils, or removal of air-filled sacs in the lungs.
  • People whose CT scan shows that 50% or more of their lung tissue is affected by emphysema (air trapping and lung damage).
  • People who have been diagnosed with asthma, based on internationally recognised criteria.
  • People who have bronchiectasis (widened and damaged airways) that is causing or significantly contributing to their cough and phlegm symptoms.
  • People who have smoked anything — including tobacco, marijuana, e-cigarettes, or vaping products — within the past two months.
  • People who are unable to walk more than 225 metres within 6 minutes.
  • People who have a serious medical condition that the lead doctor believes could put them at risk or make it harder to assess their response to treatment — for example, severe heart failure, a heart attack in the past year, kidney failure, liver disease, a stroke in the past 6 months, poorly controlled diabetes, uncontrolled high blood pressure, autoimmune disease requiring immunosuppressant medications, or a condition requiring chemotherapy.
  • People who have uncontrolled acid reflux (GERD).
  • People who have known severe high blood pressure in the lungs (pulmonary hypertension).
  • People who have a known allergy or sensitivity to medications typically used during a bronchoscopy procedure, such as lidocaine, atropine, or benzodiazepines.
  • People who are currently pregnant, breastfeeding, or planning to become pregnant during the study period.
  • People who are already taking part in another clinical trial involving an investigational (experimental) treatment.
  • People who are taking blood-thinning medications for a heart condition and, in the lead doctor's opinion, cannot safely stop those medications during the bronchoscopy procedure.
  • People who are known to have antibiotic-resistant bacteria or significant fungal organisms present in their airways.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: +86 13588706779

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Suzhou Hengruihongyuan Medical Technology Co. LTD
Registry
ClinicalTrials.gov
Start date
1 September 2025
Est. completion
1 August 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

COPD Assessment Test (CAT) Score

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov