Neural Respiratory Drive of Patients With Chronic Obstructive Pulmonary Disease

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 520120
      • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

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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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: bronchodilators; compound ipratropium bromide solution (3mg salbutamol and 500μg ipratropium, Boehringer Ingelheim Limited, Germany)	Drug: compound ipratropium bromide solution (3mg salbutamol and 500μg ipratropium, Boehringer Ingelheim Limited, Germany); inhaled compound ipratropium bromide solution (3mg salbutamol and 500μg ipratropium, Boehringer Ingelheim Limited, Germany)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the change of the neural respiratory drive	the change of the neural respiratory drive	20 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Guangzhou Medical University
• Investigators: Principal Investigator: jianheng zhang, MD, State Key Laboratory of Respiratory Disease

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): September 1, 2024

Study Registration Dates

• First Submitted: March 4, 2023
• First Submitted That Met QC Criteria: March 15, 2023
• First Posted (Actual): March 28, 2023

Study Record Updates

• Last Update Posted (Actual): May 7, 2025
• Last Update Submitted That Met QC Criteria: May 4, 2025
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: chronic obstructive pulmonary disease; neural respiratory drive
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Reproductive Control Agents; Neurotransmitter Agents; Adrenergic Agonists; Adrenergic Agents; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Anticonvulsants; Tocolytic Agents; Cholinergic Antagonists; Cholinergic Agents; Albuterol; Bromides; Ipratropium
• Other Study ID Numbers: YLS2020(172)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No