Neural Respiratory Drive of Patients With Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Neural Respiratory Drive of Patients With Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05786950
• Other study ID #: YLS2020(172)
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: March 2023
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: jianheng zhang, MD
• Phone: 13480226298
• Email: 13480226298[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

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-

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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)

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change of the neural respiratory drive	the change of the neural respiratory drive	20 minutes
Secondary	comfort sensation	The subjects scored their comfort sensation with a visual analog scale (VAS) ranging from 0 (best) to 10 (worst)	20 minutes