protocolSection identificationModule nctId: NCT06378671, orgStudyIdInfo id: ColdCough, briefTitle: Single-center Clinical Study on the Safety and Effect of Bronchoscopic Cryotherapy in Patients With Chronic Cough, acronym: ColdCough, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Guangzhou Medical University, class: OTHER, collaborators name: Ningbo SensCure Biotechnology Co., Ltd., descriptionModule briefSummary: 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., conditionsModule conditions: Chronic Cough, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: a prospective, single-center, double-blind ,randomized controlled clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: General treatment, interventions name: Cryotherapy Treatment, outcomesModule primaryOutcomes measure: Device/Surgery-Related Serious Adverse Events, primaryOutcomes measure: Device/Surgery Adverse Event Rate, primaryOutcomes measure: Serious Adverse Event Rate, primaryOutcomes measure: Device Defect Rate, primaryOutcomes measure: Cough Visual Analogue Scale (VAS), primaryOutcomes measure: Cough frequency within 2 hours, primaryOutcomes measure: Modified Cough Evaluation Tool (CET), primaryOutcomes measure: Leicester Cough Questionnaire (LCQ), primaryOutcomes measure: Tracheal Vibratory Cough Stimulation Test, primaryOutcomes measure: Capsaicin Cough Stimulation Test, primaryOutcomes measure: Performance evaluation of Cryotherapy Ablation Equipment, primaryOutcomes measure: Performance evaluation of Cryotherapy Ablation Catheter, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Guangzhou Medical University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510163, country: China, contacts name: Shiyue Li, role: CONTACT, phone: +86 13902233925, email: lishiyue@gird.cn, geoPoint lat: 23.11667, lon: 113.25, hasResults: False