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

NCT06378671 | Recruiting DMC

• 1 other identifier: ColdCough
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Cough

Keywords

Chronic Cough; Cryotherapy treatment via bronchoscopy

Outcome Measures

Primary Outcomes (12)

• 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%.

  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%.

  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%.

  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%.

  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.

  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.

  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."

  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.

  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).

  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.

  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."

  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.

  the treatment period(day0)

Study Arms (2)

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).

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.

Procedure: General treatment

Interventions

General treatment PROCEDURE

routine bronchoscopy examination, lavage, and mucosal biopsy

Cryotherapy Treatment; Not receiving cryotherapy treatment

Cryotherapy Treatment PROCEDURE

local cryotherapy treatment (around the left and right main bronchi, upper trachea, and carina)

Cryotherapy Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Medical University: lead
• Ningbo SensCure Biotechnology Co., Ltd.: collaborator

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510163, China

RECRUITING

Related Publications (20)

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• 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.

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• 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.

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• 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.

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MeSH Terms

Conditions

Chronic Cough

Condition Hierarchy (Ancestors)

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shiyue Li

CONTACT

+86 13902233925; lishiyue@gird.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: a prospective, single-center, double-blind ,randomized controlled clinical trial

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: April 22, 2024
• Study Start: April 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: September 1, 2024
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)