Single-center Clinical Study on the Safety and Effect of Bronchoscopic Cryotherapy in Patients With Chronic Cough
- Conditions
- Chronic Cough
- Interventions
- Procedure: General treatmentProcedure: Cryotherapy Treatment
- Registration Number
- NCT06378671
- Lead Sponsor
- Guangzhou Medical University
- Brief Summary
Chronic cough is one of the most common complaints in respiratory specialty clinics, imposing significant economic burden on patients and severely affecting their quality of life. Currently, the pathogenesis of chronic refractory cough remains incompletely understood, and treatment remains a major challenge in clinical practice. Cryotherapy treatment via bronchoscopy has shown efficacy in certain airway diseases, but there is currently no research reporting its effects on chronic refractory cough.
The goal of this clinical trial is to learn if Cryotherapy treatment works to treat individuals with chronic cough. It will also learn about The safety and effectiveness of the cryotherapy treatment system produced by Ningbo SensCure Biotechnology Co., Ltd.. The main questions it aims to answer are:
* Does cryotherapy treatment lower the frequency and severity of cough and enhance quality of life?
* Will there be safety or operational performance issues when using this cryotherapy treatment system? Researchers will compare cryotherapy treatment with no treatment to determine if cryotherapy treatment is effective for treating chronic cough.
Participants will:
* Take routine bronchoscopy examination, lavage, and mucosal biopsy ,with/without cryotherapy treatment locally (around the left and right main bronchi, upper trachea, and carina)
* undergo a screening period of approximately 28 days. Follow-up visits and necessary examinations will be scheduled for the 3rd day after treatment initiation and at weeks 1, 2, 4, 8, and 12 thereafter.
* Monitor vital signs and clinical manifestations.
- Detailed Description
1. Objective The objective is to treat patients with chronic cough using the cryotherapy treatment system (including cryotherapy ablation equipment and associated cryotherapy ablation catheters) to improve cough symptoms and enhance patient quality of life. Additionally, to evaluate the safety and effectiveness of the cryotherapy treatment system produced by Ningbo SensCure Biotechnology Co., Ltd., and to provide scientifically reliable data for further formal clinical trials.
2. content This is a prospective, randomized, controlled, small-sample clinical trial, with plans to enroll 20 participants. The experimental device is the cryotherapy treatment system developed and manufactured by Ningbo SensCure Biotechnology Co., Ltd. (including cryotherapy ablation equipment and associated cryotherapy ablation catheters). Safety evaluation criteria (including the incidence of device/procedure-related serious adverse events, device/procedure adverse event rate, incidence of serious adverse events, and device defect rate) and effectiveness evaluation criteria (including cough visual analog scale score, number of coughs within 2 hours, modified cough score scale, Leicester Cough Questionnaire, and cough sensitivity testing) will be used to assess the safety and effectiveness of the cryotherapy treatment system for treating patients with chronic cough.
3. Criteria and Procedures for Withdrawal/Termination of Trial Treatment
Subjects may prematurely terminate treatment or withdraw from the study due to any of the following, but not limited to:
1. Medical or safety reasons deemed necessary by the investigator for the subject to withdraw from the study;
2. Failure to meet inclusion criteria or meeting exclusion criteria after enrollment;
3. Subject's unwillingness to continue participating in the study for any reason;
4. Loss to follow-up (the investigator is unable to contact the subject to return to the clinic for primary endpoint assessment and examination);
5. Termination of the study requested by the investigator or the company for any reason.
For all subjects who prematurely terminate the study, the investigator should obtain the reason for withdrawal as much as possible, such as adverse events, correction of ineffective treatment, withdrawal from the trial based on the investigator's decision, or other reasons, and the withdrawal reason should be recorded in the Case Report Form (CRF).
4．Expected Duration of Participation for Each Subject The expected duration of participation for each subject is defined as the time from the subject's signing of the informed consent form to the end of the final follow-up visit. According to the trial design, the visit schedule for each subject is as follows: Visit 1 (screening period, pre-operative -28 days to treatment period), Visit 2 (treatment period, Day 0), Visit 3 (Day 3 ± 1 day), Visit 4 (Week 1 ± 1 day), Visit 5 (Week 2 ± 3 days), Visit 6 (Week 4 ± 3 days), Visit 7 (Week 8 ± 7 days), and Visit 8 (Week 12 ± 7 days).
5．Monitoring Plan Executor: Monitor. Monitoring Content: Whether the trial protocol is followed; whether all Case Report Form (CRF) entries are correct, complete, and consistent with the original documents such as medical records and physical examination reports, and whether there are any errors or omissions in the data. Since most of the data in the CRF are transcribed from original sources such as medical records and physical examination reports, much of the content is secondary data. Therefore, during monitoring, the content of the CRF needs to be meticulously cross-checked with the original documents to ensure that the data in the CRF are completely consistent with the original data. This process is also known as Source Data Verification (SDV).
6．Data Management and Statistical Analysis Methods A separate data folder will be established for each participant, and dedicated personnel will be responsible for data collection and entry. Adhering to Good Clinical Practice (GCP) principles, it is essential to ensure the authenticity and traceability of the data, retaining all raw data for verification purposes. Statistical analysis of the data will be conducted using SAS 9.4 or higher software.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cryotherapy Treatment General treatment The plan is to enroll 20 patients, who will be randomly assigned in a 1:1 ratio to the experimental group and the control group according to the protocol criteria. The experimental group will undergo routine bronchoscopy examination, lavage, and mucosal biopsy, followed by cryotherapy treatment locally (around the left and right main bronchi, upper trachea, and carina). Not receiving cryotherapy treatment General treatment The plan is to enroll 20 patients, who will be randomly assigned in a 1:1 ratio to the experimental group and the control group according to the protocol criteria. The control group will undergo routine bronchoscopy examination, lavage, and mucosal biopsy. Cryotherapy Treatment Cryotherapy Treatment The plan is to enroll 20 patients, who will be randomly assigned in a 1:1 ratio to the experimental group and the control group according to the protocol criteria. The experimental group will undergo routine bronchoscopy examination, lavage, and mucosal biopsy, followed by cryotherapy treatment locally (around the left and right main bronchi, upper trachea, and carina).
- Primary Outcome Measures
Name Time Method Device Defect Rate the treatment period(day0) the incidence rate of device defects = Number of occurrences of device defects / Total number of times the device was used × 100%.
Cough Visual Analogue Scale (VAS) during the screening period, the treatment period, day 3, weeks 1, 2, 4, 8, and 12 Patients will mark on a straight line marked 0-10 cm or 0-100 mm to indicate the severity of cough based on their perception. 0mm(or 0cm) indicates no cough and 100mm(or 10cm) indicates the most severe cough.
Device/Surgery-Related Serious Adverse Events Visit1~Visit8(Preoperative -28 days to week 12±7 days) the incidence of device/surgery-related serious adverse events = Number of subjects experiencing device/surgery-related serious adverse events / Total number of subjects receiving cryotherapy treatment × 100%.
Serious Adverse Event Rate Visit1~Visit8(Preoperative -28 days to week 12 ±7 days) the incidence rate of serious adverse events = Number of subjects experiencing serious adverse events / Total number of subjects receiving cryotherapy treatment × 100%.
Device/Surgery Adverse Event Rate Visit1~Visit8(Preoperative -28 days to week 12±7 days) the incidence rate of device/surgery-related adverse events = Number of subjects experiencing device/surgery-related adverse events / Total number of subjects receiving cryotherapy treatment × 100%.
Cough frequency within 2 hours during the screening period and at weeks 4 and 12 Patients will record the number of coughs they experience within a period of 2 hours based on their perception.
Performance evaluation of Cryotherapy Ablation Equipment the treatment period(day0) Assessed for startup, operational performance, interface user-friendliness, and ease of use. A smooth experiment completion with simple operation is deemed "satisfactory"; otherwise, it's considered "unsatisfactory."
Performance evaluation of Cryotherapy Ablation Catheter the treatment period(day0) Evaluated for operation, cryogenic, and passage performance. Results are categorized as: "satisfactory" for simple operation, successful lesion site arrival, and experiment completion; "fairly satisfactory" for acceptable operation and completion at the lesion site; "fair" for average operation requiring adjustments to reach the lesion site and complete the experiment; "unsatisfactory" for cumbersome operation, failure to reach the lesion site, and experiment failure.
Modified Cough Evaluation Tool (CET) during the treatment period and at weeks 1, 2, 4, 8, and 12 The modified CET includes five items assessing patients' daytime cough severity, the impact of nighttime cough on sleep, the intensity of coughing, the impact of coughing on daily life, and its psychological effects. Patients self-assess their coughing based on their experiences over the past week, rating it as "none," "very little," "some," "often," or "frequent."
Leicester Cough Questionnaire (LCQ) during the treatment period and at weeks 1, 2, 4, 8, and 12 The Chinese version of the Leicester Cough Questionnaire (LCQ) will be used to assess cough-related quality of life. It consists of 19 questions, which are divided into three health-related dimensions: physiological, psychological and social. Each question is divided into 7 grades, ranging from "All of the time" to "None of the time", according to the degree of severity, with a score ranging from 1 to 7. The score of each dimension is the total score of all the questions in this dimension/the number of questions (score of 1 to 7), and the total score is the sum of the scores of the three dimensions (score of 3 to 21). The higher the score, the better the life and health of patients.
Tracheal Vibratory Cough Stimulation Test during the screening period and at weeks 4 and 12 Instruct the subject to look straight ahead. Place the vibrator two fingers above the sternal notch and provide 65Hz vibration stimulation for 10 seconds. Record cough frequency and desire from the start of stimulation to 30 seconds after the end. Coughing or a desire to cough within 30 seconds after the end defines a positive Airway Vibratory Test (AVT).
Capsaicin Cough Stimulation Test during the screening period and at weeks 4 and 12 Employ a single-dose inhalation method with a quantified device triggered by inhalation. Begin with saline inhalation as a baseline, followed by incremental inhalation of capsaicin solution at double concentrations (1.95-1000umol/L). Record the number of coughs within 30 seconds after each inhalation.
Observation indicators: C2, C5 (concentration of capsaicin causing 2 or 5 coughs after inhalation). If coughing doesn't reach 5 times at highest concentration, C5 is considered as 1000μmol/L. The reference value of C5 for this test in normal Chinese individuals is ≥125 μmol/L.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China