Ipratropium Bromide in Peri-Operative COPD

Phase 4

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Drug: ipratropium bromide
Drug: placebo

Registration Number: NCT01943552

Lead Sponsor: Boehringer Ingelheim

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 192

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ipratropium	ipratropium bromide	500 mcg four times a day
placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Change of Forced Expiratory Volume in 1 Second (FEV1) From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery	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.

Secondary Outcome Measures

Name	Time	Method
Change of Forced Vital Capacity (FVC) From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery	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.
Change of Blood Gas Analyses From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery: 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 (Treatment day 3): arterial oxygen pressure (PaO2) value
Change of Blood Gas Analyses From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery: 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 (Treatment day 3): Oxygen saturation
Change of Blood Gas Analyses From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery: Arterial Carbon Dioxide Pressure (PaCO2) Value	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
Main Post-operative Pulmonary Complications (Including Pneumonia, Atelectasis and Acute Respiratory Failure) Within Three Weeks After the Surgery	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.

Trial Locations

Locations (9): 244.2514.86002 Boehringer Ingelheim Investigational Site
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Tianjin, China
244.2514.86006 Boehringer Ingelheim Investigational Site
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Guangzhou, China
244.2514.86009 Boehringer Ingelheim Investigational Site
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Hangzhou, China
244.2514.86008 Boehringer Ingelheim Investigational Site
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Chengdu, China
244.2514.86007 Boehringer Ingelheim Investigational Site
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Guangzhou, China
244.2514.86011 Boehringer Ingelheim Investigational Site
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Wuhan, China
244.2514.86010 Boehringer Ingelheim Investigational Site
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Guangzhou, China
244.2514.86004 Boehringer Ingelheim Investigational Site
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Shanghai, China
244.2514.86012 Boehringer Ingelheim Investigational Site
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Wuhan, China