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Completed

NCT Number: NCT05786950

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.

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Key information

Age range

35 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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, 520120, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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-

Treatment and study plan

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

Drug

inhaled compound ipratropium bromide solution (3mg salbutamol and 500μg ipratropium, Boehringer Ingelheim Limited, Germany)

Primary outcomes

  1. the change of the neural respiratory drive

    Time frame: 20 minutes

    the change of the neural respiratory drive

Secondary outcomes

  1. comfort sensation

    Time frame: 20 minutes

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

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Mar 28, 2023
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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