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Ventilation-drive Coupling to Evaluate The Efficacy of Inhaled Bronchodilators in Patients With COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Placebo
ipratropium bromide
salbutamol
Sponsored by
Zhujiang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD, central drive, bronchodilators

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

  • Zhujiang Hospital,Southern Medical Universtiy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A

Group B

Arm Description

The medication order: subjects inhaled placebo,ipratropium bromide 80μg, salbutamol 400μg in sequence.

The medication order: subjects inhaled placebo, salbutamol 400μg, ipratropium 80μg in sequence.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Respiratory pressure
Respiratory pressure parameters include gastric pressure (Pga), esophageal pressure (Pes), transdiaphragmatic pressure ( Pdi), mouth pressure (Pmo).
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).

Full Information

First Posted
November 10, 2014
Last Updated
July 26, 2015
Sponsor
Zhujiang Hospital
Collaborators
Guangzhou Panyu Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02296047
Brief Title
Ventilation-drive Coupling to Evaluate The Efficacy of Inhaled Bronchodilators in Patients With COPD
Official Title
Ventilation-drive Coupling to Evaluate The Efficacy of Inhaled Bronchodilators in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhujiang Hospital
Collaborators
Guangzhou Panyu Central Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
COPD, central drive, bronchodilators

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
The medication order: subjects inhaled placebo,ipratropium bromide 80μg, salbutamol 400μg in sequence.
Arm Title
Group B
Arm Type
Experimental
Arm Description
The medication order: subjects inhaled placebo, salbutamol 400μg, ipratropium 80μg in sequence.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Physiological Saline 9 mg/ml
Intervention Description
physiological saline
Intervention Type
Drug
Intervention Name(s)
ipratropium bromide
Other Intervention Name(s)
atrovent
Intervention Description
80 µg inhalation once
Intervention Type
Drug
Intervention Name(s)
salbutamol
Other Intervention Name(s)
Ventolin
Intervention Description
400 µg inhalation once
Primary Outcome Measure Information:
Title
Diaphragmatic function
Description
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.
Time Frame
The groups will be assessed at baseline (time zero) and ten minutes after using each drug.
Secondary Outcome Measure Information:
Title
Respiratory pressure
Description
Respiratory pressure parameters include gastric pressure (Pga), esophageal pressure (Pes), transdiaphragmatic pressure ( Pdi), mouth pressure (Pmo).
Time Frame
The groups will be assessed at baseline (time zero) and ten minutes after using each drug.
Title
Respiratory volume
Description
Respiratory volume is associated with Flow, Inspiratory capacity (IC), tidal volume (VT), respiratory rate (RR), inspiratory time (Ti),expiratory time (Te), minute ventilation (VE).
Time Frame
The groups will be assessed at baseline (time zero) and ten minutes after using each drug.
Other Pre-specified Outcome Measures:
Title
Degree of dyspnea
Description
Difference in the degree of dyspnea can be measured by Borg index.
Time Frame
The groups will be assessed at baseline (time zero) and ten minutes after using each drug.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen Xin, Doctor
Organizational Affiliation
Zhujiang Hospital,Southern Medical Unversity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhujiang Hospital,Southern Medical Universtiy
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510282
Country
China

12. IPD Sharing Statement

Learn more about this trial

Ventilation-drive Coupling to Evaluate The Efficacy of Inhaled Bronchodilators in Patients With COPD

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