Ipratropium Bromide in Peri-Operative COPD

NCT01943552 | Completed Phase 4 Results

• 1 other identifier: 244.2514
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 9

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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 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: 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

  Baseline and Treatment day 3

• 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

Study Arms (2)

ipratropium

EXPERIMENTAL

500 mcg four times a day

Drug: ipratropium bromide

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

placebo DRUG

normal saline

placebo

ipratropium bromide DRUG

ipratropium bromide

ipratropium

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (9)

244.2514.86008 Boehringer Ingelheim Investigational Site

Chengdu, China

Location

244.2514.86006 Boehringer Ingelheim Investigational Site

Guangzhou, China

Location

244.2514.86007 Boehringer Ingelheim Investigational Site

Guangzhou, China

Location

244.2514.86010 Boehringer Ingelheim Investigational Site

Guangzhou, China

Location

244.2514.86009 Boehringer Ingelheim Investigational Site

Hangzhou, China

Location

244.2514.86004 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

244.2514.86002 Boehringer Ingelheim Investigational Site

Tianjin, China

Location

244.2514.86011 Boehringer Ingelheim Investigational Site

Wuhan, China

Location

244.2514.86012 Boehringer Ingelheim Investigational Site

Wuhan, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Ipratropium

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Limitations and Caveats

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.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2013
• First Posted: September 17, 2013
• Study Start: October 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 25, 2016
• Results First Posted: September 12, 2016

Record last verified: 2016-09

Locations

CN (9)