Pulmonary Disease, Chronic ObstructivePhase 4NCT01943552

Ipratropium Bromide in Peri-Operative COPD

A Phase 4 study testing ipratropium bromide in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 9 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 50 to 75 years
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: ipratropium bromide
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 192 participants
Where: 9 sitesChina
Study dates: Oct 2013to Aug 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

China9 sites

244.2514.86008 Boehringer Ingelheim Investigational Site
Chengdu
244.2514.86006 Boehringer Ingelheim Investigational Site
Guangzhou
244.2514.86007 Boehringer Ingelheim Investigational Site
Guangzhou
244.2514.86010 Boehringer Ingelheim Investigational Site
Guangzhou
244.2514.86009 Boehringer Ingelheim Investigational Site
Hangzhou
244.2514.86004 Boehringer Ingelheim Investigational Site
Shanghai
244.2514.86002 Boehringer Ingelheim Investigational Site
Tianjin
244.2514.86011 Boehringer Ingelheim Investigational Site
Wuhan
244.2514.86012 Boehringer Ingelheim Investigational Site
Wuhan

Other trials in China

About this study

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.

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: placebo, ipratropium bromide
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

placeboDrug
normal saline
ipratropium bromideDrug
ipratropium bromide

Study groups in NCT01943552
Study group	Role	What they receive
ipratropium	Experimental	500 mcg four times a day Receives: Drug: ipratropium bromide
placebo	Placebo comparator	Not described Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: From surgery to 3 weeks post surgery, up to 21 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2013Aug 2015

First posted17 Sep 2013 (estimated)
Study startOct 2013
Primary completionJul 2015
Study completionAug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 192 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01943552
Sponsor's protocol ID: 244.2514
Status last verified: Sep 2016
First submitted: 12 Sep 2013
Last updated: 25 Oct 2016
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT01943552
Acronym / sponsor ID: 244.2514
Conditions: Pulmonary Disease, Chronic Obstructive
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 192 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Oct 2013
Primary completion: Jul 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 17 Sep 2013 (estimated)
Results: Posted 12 Sep 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 2

Arm	Type	Receives
ipratropium	Experimental	Drug: ipratropium bromide500 mcg four times a day
placebo	Placebo comparator	Drug: placebo

Who may qualify

Ages: 50 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
placebonormal saline	Drug	placebo
ipratropium bromideipratropium bromide	Drug	ipratropium

Primary outcome

Change of Forced Expiratory Volume in 1 Second (FEV1) From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery
Time frame: Baseline and Treatment day 3
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.

5 secondary outcomes

Change of Forced Vital Capacity (FVC) From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and Treatment day 3
Main Post-operative Pulmonary Complications (Including Pneumonia, Atelectasis and Acute Respiratory Failure) Within Three Weeks After the Surgery
Time frame: From surgery to 3 weeks post surgery, up to 21 days

Results and safety

Results posted to the registry on 12 Sep 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nebulized Ipratropium Bromide	96	71
Placebo	94	69

Primary outcome: Change of Forced Expiratory Volume in 1 Second (FEV1) From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery

Time frame: Baseline and Treatment day 3. Least squares mean (Standard Error). Unit: ml

Measure	Nebulized Ipratropium Bromide n = 94	Placebo n = 89
Value	169.9 (29.07)	15.0 (29.35)

Nebulized Ipratropium Bromide vs Placebo: Mean Difference (Net): 154.9 (95% CI 91.08 to 218.63), p <0.0001, ANCOVA

Population analysed: 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)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration until 14 days after the last drug administration, up to 32 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nebulized Ipratropium Bromide	5 of 96 (5.2%)	15 of 96 (15.6%)	Not reported
Placebo	4 of 94 (4.3%)	16 of 94 (17%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Pulmonary Disease, Chronic Obstructive

Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
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RecruitingPhase 3
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Chronic Graft-versus-host-disease
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Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ipratropium bromide in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 9 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Forced Expiratory Volume in 1 Second (FEV1) From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery (time frame: Baseline and Treatment day 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01943552.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.