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Neural Respiratory Drive of Patients With Chronic Obstructive Pulmonary Disease

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
compound ipratropium bromide solution (3mg salbutamol and 500μg ipratropium, Boehringer Ingelheim Limited, Germany)
Sponsored by
The First Affiliated Hospital of Guangzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Obstructive Pulmonary Disease focused on measuring neural respiratory drive, chronic obstructive pulmonary disease

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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-

Sites / Locations

  • 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 UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

bronchodilators

Arm Description

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

Outcomes

Primary Outcome Measures

the change of the neural respiratory drive
the change of the neural respiratory drive

Secondary Outcome Measures

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

Full Information

First Posted
March 4, 2023
Last Updated
March 15, 2023
Sponsor
The First Affiliated Hospital of Guangzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05786950
Brief Title
Neural Respiratory Drive of Patients With Chronic Obstructive Pulmonary Disease
Official Title
Neural Respiratory Drive of Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Guangzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
neural respiratory drive, chronic obstructive pulmonary disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
the responds of the neural respiratory drive of the chronic obstructive pulmonary disease patients after inhaling bronchodilator(3mg salbutamol and 500μg ipratropium, Boehringer Ingelheim Limited, Germany).
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
bronchodilators
Arm Type
Experimental
Arm Description
compound ipratropium bromide solution (3mg salbutamol and 500μg ipratropium, Boehringer Ingelheim Limited, Germany)
Intervention Type
Drug
Intervention Name(s)
compound ipratropium bromide solution (3mg salbutamol and 500μg ipratropium, Boehringer Ingelheim Limited, Germany)
Intervention Description
inhaled compound ipratropium bromide solution (3mg salbutamol and 500μg ipratropium, Boehringer Ingelheim Limited, Germany)
Primary Outcome Measure Information:
Title
the change of the neural respiratory drive
Description
the change of the neural respiratory drive
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
comfort sensation
Description
The subjects scored their comfort sensation with a visual analog scale (VAS) ranging from 0 (best) to 10 (worst)
Time Frame
20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jianheng zhang, MD
Phone
13480226298
Email
13480226298@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
zeguang zheng, MD
Phone
13503034012
Email
zheng862080@139.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jianheng zhang, MD
Organizational Affiliation
State Key Laboratory of Respiratory Disease
Official's Role
Principal Investigator
Facility Information:
Facility Name
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
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
520120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jianheng zhang, MD
Phone
13480226298
Email
zhangjianhengjoy@aliyun.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Neural Respiratory Drive of Patients With Chronic Obstructive Pulmonary Disease

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