Neural Respiratory Drive of Patients With Chronic Obstructive Pulmonary Disease

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: compound ipratropium bromide solution (3mg salbutamol and 500μg ipratropium, Boehringer Ingelheim Limited, Germany)

• Registration Number: NCT05786950
• Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University

Brief Summary

To investigate the relationship among the neural respiratory drive (NRD), the sensation of the dyspnea and the effect of the bronchodilator on each stage COPD patients.

Detailed Description

Different stage COPD subjects were recruited. Administration of bronchodilators was prohibited 24 hours prior to the experiment. After the application of topical anesthesia (10% xylocaine) the subject was asked to swallow the multipair esophageal electrode catheter through the nose into their right position. At the first period, the stable signals of spontaneous breathing (about 10 minutes) were collected as the baseline data. At the second period, each subject inhaled compound ipratropium bromide solution (3mg salbutamol and 500μg ipratropium, Boehringer Ingelheim Limited, Germany). A multi-pair esophageal electrode catheter with 10 coils that provided five pairs of electrodes was used to obtain the NRD signals. All NRD signals the were recorded before and after the compound ipratropium bromide solution was inhaled (about 10 minutes). The subjects scored their comfort sensation with a visual analog scale (VAS) ranging from 0 (best) to 10 (worst) at each period.

Study Timeline

• Study Start: 2023-01-01
• Status Verified: 2023-03
• Study First Submitted: 2023-03-04
• Study First Submitted QC: 2023-03-15
• Study First Posted: 2023-03-28
• Primary Completion: 2023-07-01
• Study Completion: 2024-09-01
• Last Update Submitted: 2025-05-04
• Last Update Posted: 2025-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

The diagnosis of COPD was made according to the global initiative for chronic obstructive lung disease (GOLD) guideline.

Exclusion Criteria

(1) Malignancy （2）Severe cardiovascular diseases （3）Neuromuscular and chest wall deformity (4) Cardiovascular instability (hypotension, arrhythmias, myocardial infarction) (5) Change in mental status; uncooperative patients (6) Extreme obesity （7）renal failure and severe blood electrolyte disturbances (8) Asthma-

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
bronchodilators	compound ipratropium bromide solution (3mg salbutamol and 500μg ipratropium, Boehringer Ingelheim Limited, Germany)	compound ipratropium bromide solution (3mg salbutamol and 500μg ipratropium, Boehringer Ingelheim Limited, Germany)

Primary Outcome Measures

Name	Time	Method
the change of the neural respiratory drive	20 minutes	the change of the neural respiratory drive

Secondary Outcome Measures

Name	Time	Method
comfort sensation	20 minutes	The subjects scored their comfort sensation with a visual analog scale (VAS) ranging from 0 (best) to 10 (worst)

Trial Locations

Locations (1)

1State Key Laboratory of Respiratory Disease, National clinical research center for respiratory disease, Guangzhou Institute of respiratory health. 2The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China