Ipratropium Bromide in Peri-Operative COPD

Boehringer Ingelheim

Status and phase

Completed

Phase 4

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Drug: placebo

Drug: ipratropium bromide

Study type

Interventional

Funder types

Industry

Identifiers

NCT01943552

244.2514

Details and patient eligibility

About

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.

Enrollment

192 patients

Sex

All

Ages

50 to 75 years old

Volunteers

No Healthy Volunteers

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