- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01943552
Ipratropium Bromide in Peri-Operative COPD
September 16, 2016 updated by: Boehringer Ingelheim
Peri-operative Intervention With Nebulized Ipratropium Bromide in Chinese Patients With Chronic Obstructive Pulmonary Disease (COPD): a Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Trial.
This is a randomized, double-blind, placebo-controlled, parallel-group, multi-centre trial.The trial aims to evaluate efficacy of nebulized ipratropium bromide in Chinese peri-operative patients with COPD under general anaesthesia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
192
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Chengdu, China
- 244.2514.86008 Boehringer Ingelheim Investigational Site
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Guangzhou, China
- 244.2514.86006 Boehringer Ingelheim Investigational Site
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Guangzhou, China
- 244.2514.86007 Boehringer Ingelheim Investigational Site
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Guangzhou, China
- 244.2514.86010 Boehringer Ingelheim Investigational Site
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Hangzhou, China
- 244.2514.86009 Boehringer Ingelheim Investigational Site
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Shanghai, China
- 244.2514.86004 Boehringer Ingelheim Investigational Site
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Tianjin, China
- 244.2514.86002 Boehringer Ingelheim Investigational Site
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Wuhan, China
- 244.2514.86011 Boehringer Ingelheim Investigational Site
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Wuhan, China
- 244.2514.86012 Boehringer Ingelheim Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- All patients must sign an informed consent.
- Male or female patients aged >= 40 years and <= 80 years
- All patients must be diagnosed with COPD and must meet the following spirometric criterion: post-bronchodilator forced expiratory volume in 1 second (FEV1) < 70% of forced vital capacity (FVC) at Screening Visit (Visit 1).
- All patients have relatively stable COPD (i.e. have no COPD exacerbation within 4 weeks prior to Screening Visit).
- All patients are about to receive selective surgical procedures of lobectomy or right bilobectomy or segmentectomy under general anaesthesia, whilst the estimated time of surgical procedures lasts for not less than 2 hours, and the estimated time of general anaesthesia lasts for not less than 3 hours and not longer than 5 hours.
- Patients must be able to perform all study related procedures including technically acceptable pulmonary function tests (PFTs).
Exclusion criteria:
- Patients who need maintenance treatment of bronchodilators (including anticholinergics, ß-agonists, xanthines).
- Patients with a recent history (i.e. six months or less) of myocardial infarction
- Patients with any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year
- Patients with symptomatic chronic heart failure (i.e. New York Heart Association functional class III-IV)
- Known narrow angle glaucoma
- Patients with prostatic hyperplasia or bladder neck obstruction with significant symptoms
- Patients with a history of asthma, allergic rhinitis or who have a blood eosinophil count >= 600 / mm3 (0.6×10^9/L). A repeat eosinophil count will not be conducted in these patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo
|
normal saline
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Experimental: ipratropium
500 mcg four times a day
|
ipratropium bromide
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Forced Expiratory Volume in 1 Second (FEV1) From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery
Time Frame: Baseline and Treatment day 3
|
Change of forced expiratory volume in 1 second (FEV1) from pre-bronchodilator at baseline to post-nebulization one day before the surgery (Treatment day 3).
Measurements of FEV1 were performed using calibrated electronic spirometers.
Equipment and techniques should conform to American Thoracic Society (ATS) criteria (P05-12782).
At screening visit, pulmonary function testing (PFT) was performed at baseline and repeated 30 minutes following inhalation of 4 puffs of salbutamol hydrofluoroalkanes metered-dose inhaler (HFA MDI).
At treatment day 3, pulmonary function testing was performed 60 minutes following the inhalation of investigational drug.
Spirometry was conducted with the patient in a seated position having abstained from medications.
The best of three efforts was defined as the highest FEV1 each obtained on any of three efforts meeting the ATS criteria and it was selected regardless of whether they came from different spirometric manoeuvres or the same manoeuvre.
|
Baseline and Treatment day 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Forced Vital Capacity (FVC) From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery
Time Frame: Baseline and Treatment day 3
|
Change of forced vital capacity (FVC) from pre-bronchodilator at baseline to post-nebulization one day before the surgery (Treatment day 3).
Measurements of FVC were performed using calibrated electronic spirometers.
Equipment and techniques should conform to American Thoracic Society (ATS) criteria (P05-12782).
At Visit 1, pulmonary function testing (PFT) was performed at baseline and repeated 30 minutes following inhalation of 4 puffs of salbutamol hydrofluoroalkanes metered-dose inhaler (HFA MDI).
At Visit 3, pulmonary function testing was performed 60 minutes following the inhalation of investigational drug.
Spirometry was conducted with the patient in a seated position having abstained from medications.
The best of three efforts was defined as the highest FVC each obtained on any of three efforts meeting the ATS criteria and it was selected regardless of whether they came from different spirometric manoeuvres or the same manoeuvre.
|
Baseline and Treatment day 3
|
Change of Blood Gas Analyses From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery: Arterial Oxygen Pressure (PaO2) Value
Time Frame: Baseline and Treatment day 3
|
Change of blood gas analyses from pre-bronchodilator at baseline to post-nebulization one day before the surgery (Treatment day 3): arterial oxygen pressure (PaO2) value
|
Baseline and Treatment day 3
|
Change of Blood Gas Analyses From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery: Oxygen Saturation
Time Frame: Baseline and Treatment day 3
|
Change of blood gas analyses from pre-bronchodilator at baseline to post-nebulization one day before the surgery (Treatment day 3): Oxygen saturation
|
Baseline and Treatment day 3
|
Change of Blood Gas Analyses From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery: Arterial Carbon Dioxide Pressure (PaCO2) Value
Time Frame: Baseline and Treatment day 3
|
Change of blood gas analyses from pre-bronchodilator at baseline to post-nebulization one day before the surgery (Treatment day 3): arterial carbon dioxide pressure (PaCO2) value
|
Baseline and Treatment day 3
|
Main Post-operative Pulmonary Complications (Including Pneumonia, Atelectasis and Acute Respiratory Failure) Within Three Weeks After the Surgery
Time Frame: From surgery to 3 weeks post surgery, up to 21 days
|
Number of patients with at least one main post-operative pulmonary complications (including pneumonia, atelectasis and acute respiratory failure) within three weeks after the surgery.
Post-operative pneumonia was defined by the presence of the following criteria: persistent lung infiltrate on chest X-ray or chest computerized tomography (CT)-scan, white blood cell count >10,000 /mm3 and fever.
Post-operative atelectasis was diagnosed by presence of atelectasis affecting one lobe or several lobes in chest X-ray test or chest CT-scan.
Post-operative acute respiratory failure was defined by the presence of: PaO2 < 60 mmHg and/or PaCO2 > 50 mmHg while breathing air or other evidences which were considered as respiratory failure by investigators.
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From surgery to 3 weeks post surgery, up to 21 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
September 12, 2013
First Submitted That Met QC Criteria
September 12, 2013
First Posted (Estimate)
September 17, 2013
Study Record Updates
Last Update Posted (Estimate)
October 25, 2016
Last Update Submitted That Met QC Criteria
September 16, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases, Obstructive
- Lung Diseases
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Antagonists
- Cholinergic Agents
- Anticonvulsants
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Bromides
- Ipratropium
Other Study ID Numbers
- 244.2514
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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