Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ipratropium | Experimental | 500 mcg four times a day |
|
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | normal saline |
| |
| ipratropium bromide |
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Forced Vital Capacity (FVC) From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery | 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. |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 244.2514.86008 Boehringer Ingelheim Investigational Site | Chengdu | China | ||||
| 244.2514.86006 Boehringer Ingelheim Investigational Site |
This was randomised, double-blind, placebo-controlled, parallel-group, multicentre trial which aims to evaluate efficacy and safety of nebulized ipratropium bromide in Chinese peri-operative patients with chronic obstructive pulmonary disease (COPD) under general anaesthesia.
192 patients were randomized in a 1:1 ratio(96 patients in each group).1 patient each in both treatment groups did not receive the treatment.1 patient, who was randomized to the placebo group, but received nebulized ipratropium bromide, so the actual numbers of patients received nebulized ipratropium bromide and placebo were 96 and 94 respectively
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Nebulized Ipratropium Bromide | 500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days. |
| FG001 | Placebo | 4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated set (TS): All patients who were dispensed study medication and were documented to have taken at least one dose of study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Nebulized Ipratropium Bromide | 500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days. |
| BG001 | Placebo | 4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change of Forced Expiratory Volume in 1 Second (FEV1) From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery | 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. | Full analysis set (FAS): All patients in the treated set who had observed analysable data in at least one efficacy endpoint. (Only patients with observed cases (OC) values were analysed) | Posted | Least Squares Mean | Standard Error | ml | Baseline and Treatment day 3 |
From first drug administration until 14 days after the last drug administration, up to 32 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nebulized Ipratropium Bromide | 500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post procedural pneumonia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
192 patients were entered in this trial. It was planned to treat 96 with Ipratropium bromide and 96 with Placebo. Out of these, one patient was randomised to the placebo group, but received nebulized ipratropium bromide.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
| ID | Term |
|---|---|
| D009241 | Ipratropium |
| ID | Term |
|---|---|
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
ipratropium bromide |
|
| 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 | 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 | 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 | 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 | 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. | From surgery to 3 weeks post surgery, up to 21 days |
| Guangzhou |
| China |
| 244.2514.86007 Boehringer Ingelheim Investigational Site | Guangzhou | China |
| 244.2514.86010 Boehringer Ingelheim Investigational Site | Guangzhou | China |
| 244.2514.86009 Boehringer Ingelheim Investigational Site | Hangzhou | China |
| 244.2514.86004 Boehringer Ingelheim Investigational Site | Shanghai | China |
| 244.2514.86002 Boehringer Ingelheim Investigational Site | Tianjin | China |
| 244.2514.86011 Boehringer Ingelheim Investigational Site | Wuhan | China |
| 244.2514.86012 Boehringer Ingelheim Investigational Site | Wuhan | China |
| Other Reasons |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
|
| Secondary | Change of Forced Vital Capacity (FVC) From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery | 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. | Full analysis set (FAS). (Only patients with observed cases (OC) values were analysed) | Posted | Least Squares Mean | Standard Error | ml | Baseline and Treatment day 3 |
|
|
|
|
| Secondary | Change of Blood Gas Analyses From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery: Arterial Oxygen Pressure (PaO2) Value | 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 | Full analysis set (FAS). (Only patients with observed cases (OC) values were analysed) | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Treatment day 3 |
|
|
|
|
| Secondary | Change of Blood Gas Analyses From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery: Oxygen Saturation | Change of blood gas analyses from pre-bronchodilator at baseline to post-nebulization one day before the surgery (Treatment day 3): Oxygen saturation | Full analysis set (FAS). (Only patients with observed cases (OC) values were analysed) | Posted | Least Squares Mean | Standard Error | Percentage of Oxygen | Baseline and Treatment day 3 |
|
|
|
|
| Secondary | Change of Blood Gas Analyses From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery: Arterial Carbon Dioxide Pressure (PaCO2) Value | 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 | Full analysis set (FAS). (Only patients with observed cases (OC) values were analysed) | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Treatment day 3 |
|
|
|
|
| Secondary | Main Post-operative Pulmonary Complications (Including Pneumonia, Atelectasis and Acute Respiratory Failure) Within Three Weeks After the Surgery | 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. | Surgery complete set (SCS): All patients who completed surgery. | Posted | Number | Participants | From surgery to 3 weeks post surgery, up to 21 days |
|
|
|
|
| 5 |
| 96 |
| 15 |
| 96 |
| EG001 | Placebo | 4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days. | 4 | 94 | 16 | 94 |
| Pyrexia | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Anaphylactic shock | Immune system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Post procedural pneumonia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| Sputum retention | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |