Chronic Obstructive Pulmonary Disease (COPD)NCT02296047
Ventilation-drive Coupling to Evaluate The Efficacy of Inhaled Bronchodilators in Patients With COPD
A study testing ipratropium bromide and salbutamol in people with Chronic Obstructive Pulmonary Disease (COPD), run by Zhujiang Hospital at 1 site in China.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) is a major cause of chronic morbidity, mortality and disability throughout the world, leading to a heavy social and economic burden.Bronchodilators, the most commonly used drugs in COPD patients, have been shown to reduce dyspnea, improve exercise tolerance and improve… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- ipratropium bromide and salbutamol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to May 2015
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 40-70 years old; Patients with pulmonary function test of FEV1/FVC < 70% and FEV1%pred < 50%; Patients in a clinically stable state; Patients who signed informed consent.
Who cannot join
- Patients with signs of an airway infection; Patients with an acute exacerbation during the previous 4 weeks; Patients with giant bulla(≥3cm in diameter); Patients with recent upper abdominal surgery; Patients with one or more of the following diseases: esophageal cancer, reflux esophagitis, severe obstructive sleep apnea (apnea hypopnea index>15/hr), neuromuscular disease, or significant heart failure; Patients with poor compliance.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhujiang Hospital,Southern Medical Universtiy
Guangzhou, Guangdong, 510282
About this study
Official title: Ventilation-drive Coupling to Evaluate The Efficacy of Inhaled Bronchodilators in Patients With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease (COPD) is a major cause of chronic morbidity, mortality and disability throughout the world, leading to a heavy social and economic burden.Bronchodilators, the most commonly used drugs in COPD patients, have been shown to reduce dyspnea, improve exercise tolerance and improve health status. However,conventional lung function parameters such as forced vital capacity (FVC) and forced expiratory volume in one second (FEV1) frequently fail to detect significant functional responses to bronchodilators in patients with chronic airflow obstruction. It is necessary for clinical and scientific reasons to develop a new tool to objectively assess the effect of different treatments including bronchodilator on COPD. Our previous study showed that Ventilation-drive coupling may be more sensitive and accurate to evaluate the efficacy of inhaled bronchodilators in patients with COPD because it could better reflect the pathological and physiological characteristics of COPD.
Based on the above conclusion, the present study were performed using the experimental methods of placebo and self-controlled. We aimd to explore the value of ventilation-drive coupling in evaluating the efficacy of bronchodilators on COPD and provide a reasonable basis for the clinical application of this index.
Read the detailed description
Patients were randomly assigned to one of two intervention groups:
- Group A: Patients inhaled placebo, ipratropium 80μg, salbutamol 400 μg in sequence;
- Group B: Patients inhaled placebo, salbutamol 400μg, ipratropium 80 μg in sequence.
The data were collected in 30 minutes after patients inhaled placebo,in 30 minutes after ipratropium and in 15 minutes after salbutamol.
- Being tested
- Placebo, ipratropium bromide, salbutamol
- Keywords
- COPD, central drive, bronchodilators
- 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.
PlaceboDrug
Also called Physiological Saline 9 mg/ml
physiological saline
ipratropium bromideDrug
Also called atrovent
80 µg inhalation once
salbutamolDrug
Also called Ventolin
400 µg inhalation once
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | The medication order: subjects inhaled placebo,ipratropium bromide 80μg, salbutamol 400μg in sequence. Receives: Drug: Placebo; Drug: ipratropium bromide; Drug: salbutamol |
| Group B | Experimental | The medication order: subjects inhaled placebo, salbutamol 400μg, ipratropium 80μg in sequence. Receives: Drug: Placebo; Drug: ipratropium bromide; Drug: salbutamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragmatic function
Diaphragmatic function can be assessed by diaphragm electromyogram (EMGdi), which reflect the physiological activity of the diaphragm and indicate functional status of the central drive.
Measured: The groups will be assessed at baseline (time zero) and ten minutes after using each drug.
Secondary outcomes (2)
Respiratory pressure
Respiratory pressure parameters include gastric pressure (Pga), esophageal pressure (Pes), transdiaphragmatic pressure ( Pdi), mouth pressure (Pmo).
Measured: The groups will be assessed at baseline (time zero) and ten minutes after using each drug.
Respiratory volume
Respiratory volume is associated with Flow, Inspiratory capacity (IC), tidal volume (VT), respiratory rate (RR), inspiratory time (Ti),expiratory time (Te), minute ventilation (VE).
Measured: The groups will be assessed at baseline (time zero) and ten minutes after using each drug.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Panyu Central Hospital
- Responsible party
- Sponsor
- Investigators
- Chen Xin, Doctor, Principal investigator, Zhujiang Hospital,Southern Medical Unversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296047
- Sponsor's protocol ID
- CX62782296
- Status last verified
- Nov 2014
- First submitted
- 10 Nov 2014
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilation-drive Coupling to Evaluate The Efficacy of Inhaled Bronchodilators in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02296047
- Acronym / sponsor ID
- CX62782296
- Keywords
- COPD, central drive, bronchodilators
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Collaborators
- Guangzhou Panyu Central Hospital
- Study start
- Dec 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 20 Nov 2014 (estimated)
- 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.
Chronic Obstructive Pulmonary Disease (COPD) is a major cause of chronic morbidity, mortality and disability throughout the world, leading to a heavy social and economic burden.Bronchodilators, the most commonly used drugs in COPD patients, have been shown to reduce dyspnea, improve exercise tolerance and improve health status. However,conventional lung function parameters such as forced vital capacity (FVC) and forced expiratory volume in one second (FEV1) frequently fail to detect significant functional responses to bronchodilators in patients with chronic airflow obstruction. It is necessary for clinical and scientific reasons to develop a new tool to objectively assess the effect of different treatments including bronchodilator on COPD. Our previous study showed that Ventilation-drive coupling may be more sensitive and accurate to evaluate the efficacy of inhaled bronchodilators in patients with COPD because it could better reflect the pathological and physiological characteristics of COPD.
Based on the above conclusion, the present study were performed using the experimental methods of placebo and self-controlled. We aimd to explore the value of ventilation-drive coupling in evaluating the efficacy of bronchodilators on COPD and provide a reasonable basis for the clinical application of this index.
Detailed description
Patients were randomly assigned to one of two intervention groups:
- Group A: Patients inhaled placebo, ipratropium 80μg, salbutamol 400 μg in sequence;
- Group B: Patients inhaled placebo, salbutamol 400μg, ipratropium 80 μg in sequence.
The data were collected in 30 minutes after patients inhaled placebo,in 30 minutes after ipratropium and in 15 minutes after salbutamol.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Placebo, Drug: ipratropium bromide, Drug: salbutamolThe medication order: subjects inhaled placebo,ipratropium bromide 80μg, salbutamol 400μg in sequence. |
| Group B | Experimental | Drug: Placebo, Drug: ipratropium bromide, Drug: salbutamolThe medication order: subjects inhaled placebo, salbutamol 400μg, ipratropium 80μg in sequence. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 40-70 years old; Patients with pulmonary function test of FEV1/FVC < 70% and FEV1%pred < 50%; Patients in a clinically stable state; Patients who signed informed consent.
Key exclusion criteria (1 listed)
- Patients with signs of an airway infection; Patients with an acute exacerbation during the previous 4 weeks; Patients with giant bulla(≥3cm in diameter); Patients with recent upper abdominal surgery; Patients with one or more of the following diseases: esophageal cancer, reflux esophagitis, severe obstructive sleep apnea (apnea hypopnea index>15/hr), neuromuscular disease, or significant heart failure; Patients with poor compliance.
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 |
|---|---|---|
| PlaceboAlso: Physiological Saline 9 mg/mlphysiological saline | Drug | Group A, Group B |
| ipratropium bromideAlso: atrovent80 µg inhalation once | Drug | Group A, Group B |
| salbutamolAlso: Ventolin400 µg inhalation once | Drug | Group A, Group B |
Primary outcome
Diaphragmatic function
Time frame: The groups will be assessed at baseline (time zero) and ten minutes after using each drug.
Diaphragmatic function can be assessed by diaphragm electromyogram (EMGdi), which reflect the physiological activity of the diaphragm and indicate functional status of the central drive.
2 secondary outcomes
Respiratory pressure
Time frame: The groups will be assessed at baseline (time zero) and ten minutes after using each drug.
Respiratory volume
Time frame: The groups will be assessed at baseline (time zero) and ten minutes after using each drug.
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 28 Jul 2015.
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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.
Chen Xin, Doctor principal investigator
Zhujiang Hospital,Southern Medical Unversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ipratropium bromide and salbutamol in people with Chronic Obstructive Pulmonary Disease (COPD), run by Zhujiang Hospital 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 1 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 28 Jul 2015. 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?
Diaphragmatic function (time frame: The groups will be assessed at baseline (time zero) and ten minutes after using each drug.). 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 28 Jul 2015.