Interstitial Lung Disease (ILD)
Conditions
Interventions
Sponsors
Second Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Patients must meet all of the following inclusion criteria to be enrolled in this study: 1.Signed informed consent prior to screening, with full understanding of the trial content, procedures, and potential adverse reactions, and ability to complete the study per the protocol requirements. 2.Age >= 18 years. Cohort A: ILD Population 3. Diagnosed with non-acute exacerbation fibrotic interstitial lung disease (FILDs) confirmed through multidisciplinary team (MDT) discussion. 4. High-resolution computed tomography (HRCT) showing reticulation and honeycombing >10% in non-acute exacerbation phase. 5. Presence of chronic cough symptoms for >8 weeks. Cohort B: ILD with GERD Population 6. Meets diagnostic criteria for FILD. 7. Subjects must also meet the following GERD criteria: (1) Cough as a prominent symptom (not limited to chronic cough); (2) 24-hour esophageal pH-multichannel intraluminal impedance monitoring showing DeMeester score >= 12.7 and/or symptom association probability >= 80%, and/or increased reflux episodes; OR (3) If 24-hour esophageal pH-multichannel intraluminal impedance monitoring is unavailable: a) Presence of meal-related cough; b) Accompanied by typical reflux symptoms such as retrosternal burning, regurgitation, or at least one GERD-related questionnaire score exceeding normal values [Gastroesophageal Reflux Disease Questionnaire (GerdQ) >= 8, Reflux Disease Questionnaire (RDQ) >= 12, Hull Airway Reflux Questionnaire (HARQ) >= 13, or Reflux Symptom Index (RSI) >= 13]; (4) OR subjects presenting at our outpatient clinic with typical GERD symptoms or a positive response to proton pump inhibitor (PPI) trial therapy. 8. Exclusion of common causes of chronic cough such as cough-variant asthma (CVA), upper airway cough syndrome (UACS), eosinophilic bronchitis (EB), or cough symptoms relieved by treatment targeting these conditions; Cohort C: GERD population 9. GERD subjects meet criteria 1, 2, 7, 8, Cohort D: Healthy people 10. Age- and gender-matched healthy people without chronic diseases at the time of enrollment
Exclusion criteria
Exclusion criteria: ILD-Related Exclusion Criteria 1.Patients with coexisting respiratory diseases (history of respiratory infection within the past 4 weeks) or malignancies. 2.History of allergy to materials used in cough sound detection devices related to this study or known allergic constitution. 3.Unstable physical conditions, including but not limited to severe cardiac diseases, that may interfere with the conduct of the trial. 4.History of acute exacerbation of interstitial lung disease within the past 6 months. 5.Cough symptoms caused by other factors, including but not limited to infections or long-term use (or use within the past 4 weeks) of angiotensin-converting enzyme inhibitors (ACEIs). GERD-Related Exclusion Criteria 6. Smoking history >= 10 pack-years. 7. Contraindications to gastroscopy or 24-hour esophageal pH monitoring (except for patients meeting diagnostic treatment criteria). 8. Presence of alarm symptoms, such as unexplained weight loss in the past 3 months, hematemesis, melena, or hematochezia within the past year, progressive dysphagia, anemia, or any symptoms suggestive of suspected malignancy. 9. Use of acid-suppressive agents or prokinetic drugs (except antacids) within 7 days prior to enrollment, or failure to discontinue these medications during the screening period. 10. Subjects deemed unsuitable for participation in this clinical study by the investigator, including but not limited to: patients unable to correctly use sound pickup devices under physician guidance; those who underwent major surgery within 4 weeks before the study; or those with a history of esophageal stricture, gastrointestinal ulcers, hiatal hernia, esophageal motility disorders, esophageal or gastric tumors, or upper gastrointestinal surgery (e.g., subtotal gastrectomy, anti-reflux surgery); or patients with poorly controlled hypertension (systolic blood pressure >= 160 mmHg, diastolic blood pressure >100 mmHg).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Active Voice Data; | — |
Secondary
| Measure | Time frame |
|---|---|
| Nighttime Passive Voice Data;pulmonary function;Cough Evaluation Test (CET);Gastroesophageal Reflux Disease Questionnaire (GerdQ); | — |
Countries
China
Contacts
Public ContactYue Hu
Department of Respiratory and Critical Care Medicine, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China.
Outcome results
None listed