Chronic Obstructive Pulmonary DiseaseNCT05786950
Neural Respiratory Drive of Patients With Chronic Obstructive Pulmonary Disease
A study testing compound ipratropium bromide solution (3mg salbutamol and 500μg ipratropium, Boehringer Ingelheim Limited, Germany) in people with Chronic Obstructive Pulmonary Disease, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- compound ipratropium bromide solution (3mg salbutamol and 500μg ipratropium, Boehringer Ingelheim Limited, Germany)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The diagnosis of COPD was made according to the global initiative for chronic obstructive lung disease (GOLD) guideline.
- -
Who cannot join
- 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-
Trial locations and contacts
1 site in 1 country.
China1 site
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
About this study
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- compound ipratropium bromide solution (3mg salbutamol and 500μg ipratropium, Boehringer Ingelheim Limited, Germany)
- Keywords
- neural respiratory drive, chronic obstructive pulmonary disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| bronchodilators | Experimental | compound ipratropium bromide solution (3mg salbutamol and 500μg ipratropium, Boehringer Ingelheim Limited, Germany) Receives: Drug: compound ipratropium bromide solution (3mg salbutamol and 500μg ipratropium, Boehringer Ingelheim Limited, Germany) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of the neural respiratory drive
the change of the neural respiratory drive
Measured: 20 minutes
Secondary outcomes (1)
comfort sensation
The subjects scored their comfort sensation with a visual analog scale (VAS) ranging from 0 (best) to 10 (worst)
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start1 Jan 2023
- Primary completion1 Jul 2023
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Jianheng, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- jianheng zhang, MD, Principal investigator, State Key Laboratory of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786950
- Sponsor's protocol ID
- YLS2020(172)
- Status last verified
- Mar 2023
- First submitted
- 4 Mar 2023
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Respiratory Drive of Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05786950
- Acronym / sponsor ID
- YLS2020(172)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- neural respiratory drive, chronic obstructive pulmonary disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 28 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| bronchodilators | Experimental | Drug: 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) |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The diagnosis of COPD was made according to the global initiative for chronic obstructive lung disease (GOLD) guideline.
- -
Key exclusion criteria (1 listed)
- 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-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Drug | bronchodilators |
Primary outcome
the change of the neural respiratory drive
Time frame: 20 minutes
the change of the neural respiratory drive
1 secondary outcome
comfort sensation
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jianheng zhang, MD principal investigator
State Key Laboratory of Respiratory Disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing compound ipratropium bromide solution (3mg salbutamol and 500μg ipratropium, Boehringer Ingelheim Limited, Germany) in people with Chronic Obstructive Pulmonary Disease, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change of the neural respiratory drive (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.