Clinical trial NCT01943552: Ipratropium Bromide in Peri-Operative COPD
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-09-17
Enrollment: 192
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of Forced Expiratory Volume in 1 Second (FEV1) From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery
timeFrame: Baseline and Treatment day 3
Secondary outcomes:
measure: Change of Forced Vital Capacity (FVC) From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery
timeFrame: Baseline and Treatment day 3
measure: Change of Blood Gas Analyses From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery: Arterial Oxygen Pressure (PaO2) Value
timeFrame: Baseline and Treatment day 3
measure: Change of Blood Gas Analyses From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery: Oxygen Saturation
timeFrame: Baseline and Treatment day 3
measure: Change of Blood Gas Analyses From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery: Arterial Carbon Dioxide Pressure (PaCO2) Value
timeFrame: Baseline and Treatment day 3
measure: Main Post-operative Pulmonary Complications (Including Pneumonia, Atelectasis and Acute Respiratory Failure) Within Three Weeks After the Surgery
timeFrame: From surgery to 3 weeks post surgery, up to 21 days
Other outcomes:
Locations:
city: Chengdu
country: China
facility: 244.2514.86008 Boehringer Ingelheim Investigational Site
city: Guangzhou
country: China
facility: 244.2514.86006 Boehringer Ingelheim Investigational Site
city: Guangzhou
country: China
facility: 244.2514.86007 Boehringer Ingelheim Investigational Site
city: Guangzhou
country: China
facility: 244.2514.86010 Boehringer Ingelheim Investigational Site
city: Hangzhou
country: China
facility: 244.2514.86009 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 244.2514.86004 Boehringer Ingelheim Investigational Site
city: Tianjin
country: China
facility: 244.2514.86002 Boehringer Ingelheim Investigational Site
city: Wuhan
country: China
facility: 244.2514.86011 Boehringer Ingelheim Investigational Site
city: Wuhan
country: China
facility: 244.2514.86012 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: