Ipratropium Bromide in Peri-Operative COPD

Pulmonary Disease, Chronic Obstructive Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01943552
• Other study ID #: 244.2514
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2013
• Last updated: September 23, 2015
• Start date: October 2013
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: China Food and Drug Administration (CFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• placebo
normal saline
• ipratropium bromide
ipratropium bromide

Locations

Country	Name	City	State
China	244.2514.86008 Boehringer Ingelheim Investigational Site	Chengdu
China	244.2514.86006 Boehringer Ingelheim Investigational Site	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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of FEV1 from pre-bronchodilator at baseline to post-nebulization one day before the surgery (Treatment Day 3)		treatment day 3	No
Secondary	Change of FVC from pre-bronchodilator at baseline to post-nebulization one day before the surgery (Treatment Day 3)		treatment day 3	No
Secondary	Main post-operative pulmonary complications (including pneumonia, atelectasis and acute respiratory failure) within three weeks after the surgery		25 days	No
Secondary	Change of blood gas analyses from pre-bronchodilator at baseline to post-nebulization one day before the surgery (Treatment Day 3): arterial oxygen tension (PaO2) value, arterial oxygen saturation and arterial carbon dioxide tension (paCO2) value		treatment day 3	No