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Trial record 61 of 150 for:    Ipratropium OR atrovent

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

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ClinicalTrials.gov Identifier: NCT02296047
Recruitment Status : Completed
First Posted : November 20, 2014
Last Update Posted : July 28, 2015
Sponsor:
Collaborator:
Guangzhou Panyu Central Hospital
Information provided by (Responsible Party):
Zhujiang Hospital

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.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: Placebo Drug: ipratropium bromide Drug: salbutamol Not Applicable

Detailed Description:

Patients were randomly assigned to one of two intervention groups:

  1. Group A: Patients inhaled placebo, ipratropium 80μg, salbutamol 400 μg in sequence;
  2. 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Ventilation-drive Coupling to Evaluate The Efficacy of Inhaled Bronchodilators in Patients With Chronic Obstructive Pulmonary Disease
Study Start Date : December 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: Group A
The medication order: subjects inhaled placebo,ipratropium bromide 80μg, salbutamol 400μg in sequence.
Drug: Placebo
physiological saline
Other Name: Physiological Saline 9 mg/ml

Drug: ipratropium bromide
80 µg inhalation once
Other Name: atrovent

Drug: salbutamol
400 µg inhalation once
Other Name: Ventolin

Experimental: Group B
The medication order: subjects inhaled placebo, salbutamol 400μg, ipratropium 80μg in sequence.
Drug: Placebo
physiological saline
Other Name: Physiological Saline 9 mg/ml

Drug: ipratropium bromide
80 µg inhalation once
Other Name: atrovent

Drug: salbutamol
400 µg inhalation once
Other Name: Ventolin




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Respiratory pressure [ Time Frame: The groups will be assessed at baseline (time zero) and ten minutes after using each drug. ]
    Respiratory pressure parameters include gastric pressure (Pga), esophageal pressure (Pes), transdiaphragmatic pressure ( Pdi), mouth pressure (Pmo).

  2. Respiratory volume [ Time Frame: The groups will be assessed at baseline (time zero) and ten minutes after using each drug. ]
    Respiratory volume is associated with Flow, Inspiratory capacity (IC), tidal volume (VT), respiratory rate (RR), inspiratory time (Ti),expiratory time (Te), minute ventilation (VE).


Other Outcome Measures:
  1. Degree of dyspnea [ Time Frame: The groups will be assessed at baseline (time zero) and ten minutes after using each drug. ]
    Difference in the degree of dyspnea can be measured by Borg index.



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02296047


Locations
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China, Guangdong
Zhujiang Hospital,Southern Medical Universtiy
Guangzhou, Guangdong, China, 510282
Sponsors and Collaborators
Zhujiang Hospital
Guangzhou Panyu Central Hospital
Investigators
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Principal Investigator: Chen Xin, Doctor Zhujiang Hospital,Southern Medical Unversity

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Responsible Party: Zhujiang Hospital
ClinicalTrials.gov Identifier: NCT02296047     History of Changes
Other Study ID Numbers: CX62782296
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: July 28, 2015
Last Verified: November 2014
Keywords provided by Zhujiang Hospital:
COPD, central drive, bronchodilators
Additional relevant MeSH terms:
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Ipratropium
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Bromides
Albuterol
Bronchodilator Agents
Anticonvulsants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Cholinergic Agents