Chronic CoughColdCoughNCT06378671

Single-center Clinical Study on the Safety and Effect of Bronchoscopic Cryotherapy in Patients With Chronic Cough

A study testing General treatment and Cryotherapy Treatment in people with Chronic Cough, run by Guangzhou Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Chronic Cough
What is being tested?: General treatment and Cryotherapy Treatment
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 1 siteChina
Study dates: Apr 2024to Sep 2024
Phase: Interventional
Are there results?: None posted in the registry

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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Inclusion Criteria(To be eligible, all of the following criteria must be met):

Age between 18 and 65 years, regardless of gender;
Patients with cough of unknown etiology or cause, lasting for more than 8 weeks;
Cough Visual Analogue Scale (VAS) score ≥ 50；
Willingness to provide voluntary informed consent and agree to follow-up;
The investigator believes that the overall status of the subjects does not affect the evaluation and completion of the trial.

Exclusion Criteria(Any one of the following criteria must not be met to be eligible):

Presence of other diseases that may affect treatment efficacy and prognosis.
Severe underlying conditions such as heart, brain, or lung diseases.
Inability to tolerate bronchoscopy procedures and painless anesthesia.
Women who are pregnant, breastfeeding, or planning pregnancy.
Intravenous drug users.
Participation in or currently participating in other clinical studies involving drugs, devices, or other interventions within the month prior to enrollment.
Other conditions deemed unsuitable for inclusion in this study by the investigators, such as anatomical unsuitability, psychiatric disorders, or psychological disorders.

Trial locations and contacts

1 site in 1 country.

Shiyue Li contact

+86 13902233925

lishiyue@gird.cn

China1 site, 1 recruiting

The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510163
Shiyue Li, +86 13902233925, lishiyue@gird.cn
Recruiting

Other trials in China

About this study

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.

Read the detailed description

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.
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.
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:

Medical or safety reasons deemed necessary by the investigator for the subject to withdraw from the study;
Failure to meet inclusion criteria or meeting exclusion criteria after enrollment;
Subject's unwillingness to continue participating in the study for any reason;
Loss to follow-up (the investigator is unable to contact the subject to return to the clinic for primary endpoint assessment and examination);
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.

Conditions: Chronic Cough
Being tested: General treatment, Cryotherapy Treatment
Keywords: Chronic Cough, Cryotherapy treatment via bronchoscopy
Medical subject headings: Chronic Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

General treatmentProcedure or surgery
routine bronchoscopy examination, lavage, and mucosal biopsy
Cryotherapy TreatmentProcedure or surgery
local cryotherapy treatment (around the left and right main bronchi, upper trachea, and carina)

Study groups in NCT06378671
Study group	Role	What they receive
Cryotherapy Treatment	Experimental	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). Receives: Procedure: General treatment; Procedure: Cryotherapy Treatment
Not receiving cryotherapy treatment	Sham comparator	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. Receives: Procedure: General treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Device/Surgery-Related Serious Adverse Events
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%.
Measured: Visit1~Visit8(Preoperative -28 days to week 12±7 days)
Device/Surgery Adverse Event Rate
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%.
Measured: Visit1~Visit8(Preoperative -28 days to week 12±7 days)
Serious Adverse Event Rate
the incidence rate of serious adverse events = Number of subjects experiencing serious adverse events / Total number of subjects receiving cryotherapy treatment × 100%.
Measured: Visit1~Visit8(Preoperative -28 days to week 12 ±7 days)
Device Defect Rate
the incidence rate of device defects = Number of occurrences of device defects / Total number of times the device was used × 100%.
Measured: the treatment period(day0)
Cough Visual Analogue Scale (VAS)
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.
Measured: during the screening period, the treatment period, day 3, weeks 1, 2, 4, 8, and 12
Cough frequency within 2 hours
Patients will record the number of coughs they experience within a period of 2 hours based on their perception.
Measured: during the screening period and at weeks 4 and 12
Modified Cough Evaluation Tool (CET)
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."
Measured: during the treatment period and at weeks 1, 2, 4, 8, and 12
Leicester Cough Questionnaire (LCQ)
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.
Measured: during the treatment period and at weeks 1, 2, 4, 8, and 12
Tracheal Vibratory Cough Stimulation Test
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).
Measured: during the screening period and at weeks 4 and 12
Capsaicin Cough Stimulation Test
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.
Measured: during the screening period and at weeks 4 and 12
Performance evaluation of Cryotherapy Ablation Equipment
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."
Measured: the treatment period(day0)
Performance evaluation of Cryotherapy Ablation Catheter
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.
Measured: the treatment period(day0)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2024Sep 2024

First posted22 Apr 2024
Study startApr 2024 (estimated)
Primary completionJul 2024 (estimated)
Study completionSep 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (20)Papers the sponsor has linked to this study.
Other trials for Chronic CoughStudies 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: Randomised
Intervention model: Parallel groups
Model description: a prospective, single-center, double-blind ,randomized controlled clinical trial
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 20 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06378671
Sponsor's protocol ID: ColdCough
Acronym: ColdCough
Status last verified: Apr 2024
First submitted: 7 Apr 2024
Last updated: 25 Apr 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Song WJ, Chang YS, Faruqi S, Kim JY, Kang MG, Kim S, Jo EJ, Kim MH, Plevkova J, Park HW, Cho SH, Morice AH. The global epidemiology of chronic cough in adults: a systematic review and meta-analysis. Eur Respir J. 2015 May;45(5):1479-81. doi: 10.1183/09031936.00218714. Epub 2015 Feb 5. No abstract available.
PubMed 25657027
Lai K, Chen R, Lin J, Huang K, Shen H, Kong L, Zhou X, Luo Z, Yang L, Wen F, Zhong N. A prospective, multicenter survey on causes of chronic cough in China. Chest. 2013 Mar;143(3):613-620. doi: 10.1378/chest.12-0441.
PubMed 23238526
Gibson PG, Vertigan AE. Management of chronic refractory cough. BMJ. 2015 Dec 14;351:h5590. doi: 10.1136/bmj.h5590.
PubMed 26666537
Canning BJ, Chang AB, Bolser DC, Smith JA, Mazzone SB, McGarvey L; CHEST Expert Cough Panel. Anatomy and neurophysiology of cough: CHEST Guideline and Expert Panel report. Chest. 2014 Dec;146(6):1633-1648. doi: 10.1378/chest.14-1481.
PubMed 25188530
Nasra J, Belvisi MG. Modulation of sensory nerve function and the cough reflex: understanding disease pathogenesis. Pharmacol Ther. 2009 Dec;124(3):354-75. doi: 10.1016/j.pharmthera.2009.09.006. Epub 2009 Oct 7.
PubMed 19818366
Khalid S, Murdoch R, Newlands A, Smart K, Kelsall A, Holt K, Dockry R, Woodcock A, Smith JA. Transient receptor potential vanilloid 1 (TRPV1) antagonism in patients with refractory chronic cough: a double-blind randomized controlled trial. J Allergy Clin Immunol. 2014 Jul;134(1):56-62. doi: 10.1016/j.jaci.2014.01.038. Epub 2014 Mar 22.
PubMed 24666696
Belvisi MG, Birrell MA, Wortley MA, Maher SA, Satia I, Badri H, Holt K, Round P, McGarvey L, Ford J, Smith JA. XEN-D0501, a Novel Transient Receptor Potential Vanilloid 1 Antagonist, Does Not Reduce Cough in Patients with Refractory Cough. Am J Respir Crit Care Med. 2017 Nov 15;196(10):1255-1263. doi: 10.1164/rccm.201704-0769OC.
PubMed 28650204
Long L, Yao H, Tian J, Luo W, Yu X, Yi F, Chen Q, Xie J, Zhong N, Chung KF, Lai K. Heterogeneity of cough hypersensitivity mediated by TRPV1 and TRPA1 in patients with chronic refractory cough. Respir Res. 2019 Jun 6;20(1):112. doi: 10.1186/s12931-019-1077-z.
PubMed 31170994
Mai Y, Zhan C, Zhang S, Liu J, Liang W, Cai J, Lai K, Zhong N, Chen R. Arnold Nerve Reflex: Vagal Hypersensitivity in Chronic Cough With Various Causes. Chest. 2020 Jul;158(1):264-271. doi: 10.1016/j.chest.2019.11.041. Epub 2020 Jan 13.
PubMed 31945317
Niimi A, Chung KF. Airway inflammation and remodelling changes in patients with chronic cough: do they tell us about the cause of cough? Pulm Pharmacol Ther. 2004;17(6):441-6. doi: 10.1016/j.pupt.2004.09.004.
PubMed 15564089
Niimi A, Torrego A, Nicholson AG, Cosio BG, Oates TB, Chung KF. Nature of airway inflammation and remodeling in chronic cough. J Allergy Clin Immunol. 2005 Sep;116(3):565-70. doi: 10.1016/j.jaci.2005.07.010.
PubMed 16159625
Matsumoto H, Niimi A, Tabuena RP, Takemura M, Ueda T, Yamaguchi M, Matsuoka H, Jinnai M, Chin K, Mishima M. Airway wall thickening in patients with cough variant asthma and nonasthmatic chronic cough. Chest. 2007 Apr;131(4):1042-9. doi: 10.1378/chest.06-1025.
PubMed 17426208
Nakaji H, Niimi A, Matsuoka H, Iwata T, Cui S, Matsumoto H, Ito I, Oguma T, Otsuka K, Takeda T, Inoue H, Tajiri T, Nagasaki T, Kanemitsu Y, Chin K, Mishima M. Airway remodeling associated with cough hypersensitivity as a consequence of persistent cough: An experimental study. Respir Investig. 2016 Nov;54(6):419-427. doi: 10.1016/j.resinv.2016.06.005. Epub 2016 Jul 31.
PubMed 27886853
Hara J, Fujimura M, Ueda A, Myou S, Oribe Y, Ohkura N, Kita T, Yasui M, Kasahara K. Effect of pressure stress applied to the airway on cough-reflex sensitivity in Guinea pigs. Am J Respir Crit Care Med. 2008 Mar 15;177(6):585-92. doi: 10.1164/rccm.200703-457OC. Epub 2008 Jan 10.
PubMed 18187695
Sen RP, Walsh TE. Fiberoptic bronchoscopy for refractory cough. Chest. 1991 Jan;99(1):33-5. doi: 10.1378/chest.99.1.33.
PubMed 1984981

Want to know more?

Shiyue Li

+86 13902233925

lishiyue@gird.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Office-Based Superior Laryngeal Nerve Block for Treatment of Neurogenic Cough
Cough
RecruitingPhase 2
The Effect of Nalbuphine Extended-Release (NAL ER) on Cough in Participants With Refractory Chronic Cough (RCC)
Refractory Chronic Cough
Recruiting
Feasibility, Acceptability, and Safety Trial of Brief, Breath Control-Focused Acceptance and Commitment Therapy in Adults With Chronic Cough
Chronic Cough
Not yet recruitingPhase 4
A 2x2 Factorial, Randomized, Open-label Trial to Evaluate Neuromodulators and Cough Control Therapy in Patients With Refractory or Unexplained Chronic Cough
Cough, Refractory Chronic Cough
RecruitingPhase 2
A Study to Investigate the Efficacy and Safety of SC0032, a Magnesium Salt Oral Spray, in Adults With Refractory or Unexplained Chronic Cough
Refractory Chronic Cough and Unexplained Chronic Cough

All Chronic Cough trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single-center Clinical Study on the Safety and Effect of Bronchoscopic Cryotherapy in Patients With Chronic Cough
ClinicalTrials.gov ID: NCT06378671
Acronym / sponsor ID: ColdCough / ColdCough
Conditions: Chronic Cough
Keywords: Chronic Cough, Cryotherapy treatment via bronchoscopy
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 20 participants (estimated)
Lead sponsor: Guangzhou Medical UniversityUniversity, hospital or other
Collaborators: Ningbo SensCure Biotechnology Co., Ltd.
Study start: Apr 2024 (estimated)
Primary completion: Jul 2024 (estimated)
Study completion: Sep 2024 (estimated)
First posted: 22 Apr 2024 (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.

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

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.
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.
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:

Medical or safety reasons deemed necessary by the investigator for the subject to withdraw from the study;
Failure to meet inclusion criteria or meeting exclusion criteria after enrollment;
Subject's unwillingness to continue participating in the study for any reason;
Loss to follow-up (the investigator is unable to contact the subject to return to the clinic for primary endpoint assessment and examination);
Termination of the study requested by the investigator or the company for any reason.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: a prospective, single-center, double-blind ,randomized controlled clinical trial

Arm	Type	Receives
Cryotherapy Treatment	Experimental	Procedure: General treatment, Procedure: Cryotherapy TreatmentThe 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	Sham comparator	Procedure: General treatmentThe 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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
General treatmentroutine bronchoscopy examination, lavage, and mucosal biopsy	Procedure or surgery	Cryotherapy Treatment, Not receiving cryotherapy treatment
Cryotherapy Treatmentlocal cryotherapy treatment (around the left and right main bronchi, upper trachea, and carina)	Procedure or surgery	Cryotherapy Treatment

Primary outcome

Device/Surgery-Related Serious Adverse Events
Time frame: 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%.
Device/Surgery Adverse Event Rate
Time frame: 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%.
Serious Adverse Event Rate
Time frame: 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 Defect Rate
Time frame: 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)
Time frame: 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.
Cough frequency within 2 hours
Time frame: 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.
Modified Cough Evaluation Tool (CET)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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.
Performance evaluation of Cryotherapy Ablation Equipment
Time frame: 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
Time frame: 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.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
Background: PubMed 25657027Song WJ, Chang YS, Faruqi S, Kim JY, Kang MG, Kim S, Jo EJ, Kim MH, Plevkova J, Park HW, Cho SH, Morice AH. The global epidemiology of chronic cough in adults: a systematic review and meta-analysis. Eur Respir J. 2015 May;45(5):1479-81. doi: 10.1183/09031936.00218714. Epub 2015 Feb 5. No abstract available.
Background: PubMed 23238526Lai K, Chen R, Lin J, Huang K, Shen H, Kong L, Zhou X, Luo Z, Yang L, Wen F, Zhong N. A prospective, multicenter survey on causes of chronic cough in China. Chest. 2013 Mar;143(3):613-620. doi: 10.1378/chest.12-0441.
Background: PubMed 26666537Gibson PG, Vertigan AE. Management of chronic refractory cough. BMJ. 2015 Dec 14;351:h5590. doi: 10.1136/bmj.h5590.
Background: PubMed 25188530Canning BJ, Chang AB, Bolser DC, Smith JA, Mazzone SB, McGarvey L; CHEST Expert Cough Panel. Anatomy and neurophysiology of cough: CHEST Guideline and Expert Panel report. Chest. 2014 Dec;146(6):1633-1648. doi: 10.1378/chest.14-1481.
Background: PubMed 19818366Nasra J, Belvisi MG. Modulation of sensory nerve function and the cough reflex: understanding disease pathogenesis. Pharmacol Ther. 2009 Dec;124(3):354-75. doi: 10.1016/j.pharmthera.2009.09.006. Epub 2009 Oct 7.
Background: PubMed 24666696Khalid S, Murdoch R, Newlands A, Smart K, Kelsall A, Holt K, Dockry R, Woodcock A, Smith JA. Transient receptor potential vanilloid 1 (TRPV1) antagonism in patients with refractory chronic cough: a double-blind randomized controlled trial. J Allergy Clin Immunol. 2014 Jul;134(1):56-62. doi: 10.1016/j.jaci.2014.01.038. Epub 2014 Mar 22.
Background: PubMed 28650204Belvisi MG, Birrell MA, Wortley MA, Maher SA, Satia I, Badri H, Holt K, Round P, McGarvey L, Ford J, Smith JA. XEN-D0501, a Novel Transient Receptor Potential Vanilloid 1 Antagonist, Does Not Reduce Cough in Patients with Refractory Cough. Am J Respir Crit Care Med. 2017 Nov 15;196(10):1255-1263. doi: 10.1164/rccm.201704-0769OC.
Background: PubMed 31170994Long L, Yao H, Tian J, Luo W, Yu X, Yi F, Chen Q, Xie J, Zhong N, Chung KF, Lai K. Heterogeneity of cough hypersensitivity mediated by TRPV1 and TRPA1 in patients with chronic refractory cough. Respir Res. 2019 Jun 6;20(1):112. doi: 10.1186/s12931-019-1077-z.
Background: PubMed 31945317Mai Y, Zhan C, Zhang S, Liu J, Liang W, Cai J, Lai K, Zhong N, Chen R. Arnold Nerve Reflex: Vagal Hypersensitivity in Chronic Cough With Various Causes. Chest. 2020 Jul;158(1):264-271. doi: 10.1016/j.chest.2019.11.041. Epub 2020 Jan 13.
Background: PubMed 15564089Niimi A, Chung KF. Airway inflammation and remodelling changes in patients with chronic cough: do they tell us about the cause of cough? Pulm Pharmacol Ther. 2004;17(6):441-6. doi: 10.1016/j.pupt.2004.09.004.
Background: PubMed 16159625Niimi A, Torrego A, Nicholson AG, Cosio BG, Oates TB, Chung KF. Nature of airway inflammation and remodeling in chronic cough. J Allergy Clin Immunol. 2005 Sep;116(3):565-70. doi: 10.1016/j.jaci.2005.07.010.
Background: PubMed 17426208Matsumoto H, Niimi A, Tabuena RP, Takemura M, Ueda T, Yamaguchi M, Matsuoka H, Jinnai M, Chin K, Mishima M. Airway wall thickening in patients with cough variant asthma and nonasthmatic chronic cough. Chest. 2007 Apr;131(4):1042-9. doi: 10.1378/chest.06-1025.
Individual participant dataSharing planned: No

Related trials for Chronic Cough

RecruitingObservational study
Office-Based Superior Laryngeal Nerve Block for Treatment of Neurogenic Cough
Cough
RecruitingPhase 2
The Effect of Nalbuphine Extended-Release (NAL ER) on Cough in Participants With Refractory Chronic Cough (RCC)
Refractory Chronic Cough
Recruiting
Feasibility, Acceptability, and Safety Trial of Brief, Breath Control-Focused Acceptance and Commitment Therapy in Adults With Chronic Cough
Chronic Cough
Not yet recruitingPhase 4
A 2x2 Factorial, Randomized, Open-label Trial to Evaluate Neuromodulators and Cough Control Therapy in Patients With Refractory or Unexplained Chronic Cough
Cough, Refractory Chronic Cough
RecruitingPhase 2
A Study to Investigate the Efficacy and Safety of SC0032, a Magnesium Salt Oral Spray, in Adults With Refractory or Unexplained Chronic Cough
Refractory Chronic Cough and Unexplained Chronic Cough

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. This study is not recruiting at the moment.

Shiyue Li contact

+86 13902233925

lishiyue@gird.cn

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing General treatment and Cryotherapy Treatment in people with Chronic Cough, run by Guangzhou Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: status not confirmed, as of the sponsor's last update on 25 Apr 2024. 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 China. 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shiyue Li (+86 13902233925, lishiyue@gird.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Device/Surgery-Related Serious Adverse Events (time frame: Visit1~Visit8(Preoperative -28 days to week 12±7 days)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06378671, which also lists 20 linked publications.

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 25 Apr 2024.