Pulmonary Disease, Chronic ObstructivePhase 3NCT02177253

Ipratropium Bromide/Salbutamol Delivered by the Respimat® Inhaler Compared to Ipratropium Bromide Respimat®, COMBIVENT® Inhalation Aerosol and Placebo in Adults With Chronic Obstructive Pulmonary Disease

A Phase 3 study testing Ipratropium bromide / Salbutamol, Ipratropium bromide and COMBIVENT Inhalation Aerosol in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 40 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: Ipratropium bromide / Salbutamol, Ipratropium bromide and COMBIVENT Inhalation Aerosol
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,118 participants
Where: No sites listed yet
Study dates: Oct 2002to Mar 2004
Phase: Phase 3
Are there results?: None posted in the registry

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 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

All patients must have a diagnosis of COPD and the following spirometric criteria:
Visit 1 (Screening) and Visit 2: Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 ≤65% of predicted normal and FEV1 ≤70% of FVC
Male or female patients 40 years of age or older
Patients must have a smoking history of more than ten pack-years. A pack-year is defined as the equivalent of smoking one pack of 20 cigarettes per day for a year
Patients must be able to perform pulmonary function tests and maintain records during the study period as required in the protocol
Patients must be able to be trained in the proper use of an MDI (metered dose inhaler) and the Respimat® inhaler
All patients must sign an Informed Consent Form prior to participation in the trial

Who cannot join

Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study
Patients with clinically relevant abnormal baseline hematology, blood chemistry or urinalysis. If the abnormality defines a disease listed as an exclusion criterion, the patient is excluded
All patients with a SGOT (serum glutamic oxaloacetic transaminase) >80 IU/L, SGPT (serum glutamic pyruvic transaminase) >80 IU/L, bilirubin >2.0 mg/dL or creatinine >2.0 mg/dL will be excluded regardless of the clinical condition
Patients who have a total blood eosinophil count ≥600/mm3
Patients with a recent history (i.e., one year or less) of myocardial infarction
Patients with a recent history (i.e., three years or less) of heart failure or patients with any cardiac arrhythmia requiring drug therapy

Show all 27Show fewer

Patients with a history of cancer, other than treated basal cell carcinoma, within the last 5 years
Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis
Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of a thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1
Patients with a history of asthma or allergic rhinitis
Patients with a history of and/or active alcohol or drug abuse
Patients with known active tuberculosis
Patients with an upper or lower respiratory tract infection or COPD exacerbation in the 6 weeks prior to the Screening Visit (Visit 1) or during the baseline period
Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction
Patients with known narrow-angle glaucoma
Patients with current significant psychiatric disorders
Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy
Patients who are being treated with cromolyn sodium or nedocromil sodium
Patients who are being treated with antihistamines for any excluded allergic conditions
Patients using oral corticosteroid medication at unstable doses (i.e., less than 6 weeks on a stable dose) or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day
Patients who initiated use of an inhaled steroid or changed doses less than 6 weeks prior to the Screening Visit (Visit 1) or during the baseline period
Patients who are being treated with beta-blocker medications, MAO (monoamine oxidase) inhibitors or tricyclic antidepressants. Beta blocker eye medications (e.g., Betoptic) for treatment of non-narrow angle glaucoma are allowed
Patients who have had changes in their therapeutic plan within the last 6 weeks prior to the Screening Visit (Visit 1) or during the baseline period
Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception
Patients with known hypersensitivity to anticholinergic drugs or any component of the ipratropium bromide/salbutamol Respimat® solution (including BAC (Benzalkonium chloride) and EDTA (Ethylenediaminetetraacetic acid)) or the ipratropium bromide/salbutamol MDI components
Previous participation in this study
Patients who are currently participating in another study

About this study

Official title: A Comparison of Ipratropium Bromide/Salbutamol (40 mcg / 200 mcg, One Inhalation) Delivered by the Respimat ® Inhaler to COMBIVENT Inhalation Aerosol (Two Inhalations), Ipratropium Bromide Respimat ® and Placebo of Each Formulation in a 12-week, Double-blind, Safety and Efficacy Study in Adults With Chronic Obstructive Pulmonary Disease

The primary objective of this study was to compare the long-term (12-week) bronchodilator efficacy and safety of ipratropium bromide / salbutamol combination administered by the Respimat® 40 mcg / 200 mcg (one inhalation q.i.d.) to COMBIVENT Inhalation Aerosol (two inhalations q.i.d.), ipratropium bromide Respimat® (one inhalation q.i.d.) and Placebo formulations of each in patients with Chronic Obstructive Pulmonary Disease (COPD). An additional objective was to show the superiority of Combivent Respimat as compared to ipratropium bromide (40 mcg) Respimat. Steady state pharmacokinetics over one dosing interval following four weeks of therapy were also characterized.

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Ipratropium bromide / Salbutamol, Placebo Inhalation solution, Ipratropium bromide, COMBIVENT Inhalation Aerosol, Placebo Inhalation Aerosol
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.

Ipratropium bromide / SalbutamolDrug
Placebo Inhalation solutionDrug
Ipratropium bromideDrug
COMBIVENT Inhalation AerosolDrug
Placebo Inhalation AerosolDrug

Study groups in NCT02177253
Study group	Role	What they receive
Ipratropium bromide / Salbutamol Inhalation solution	Experimental	Not described Receives: Drug: Ipratropium bromide / Salbutamol
Placebo Inhalation solution	Placebo comparator	Not described Receives: Drug: Placebo Inhalation solution
Ipratropium bromide Inhalation solution	Experimental	Not described Receives: Drug: Ipratropium bromide
COMBIVENT Inhalation Aerosol (ipratropium bromide/salbutamol)	Active comparator	Not described Receives: Drug: COMBIVENT Inhalation Aerosol
Placebo Inhalation Aerosol	Placebo comparator	Not described Receives: Drug: Placebo Inhalation Aerosol

What is being measured

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

FEV1 TAUC0-6 (Total area under the FEV1 (forced expiratory volume in one second) curve from 0 to 6 hours divided by six)
Measured: Day 85

Secondary outcomes (25)

FEV1 TAUC0-6
Measured: Days 1, 29 and 57
FEV1 TAUC0-8
Measured: Days 1, 29, 57 and 85
Peak FEV1 post treatment over two hours
Measured: Days 1, 29, 57 and 85
Change from baseline in Peak FEV1 response
Measured: Days 1, 29, 57 and 85
Area under the FEV1 curve from 0 to 6 hours above test-day baseline divided by six for normalization (AUC0-6)
Measured: Days 1, 29, 57 and 85
Onset of therapeutic FEV1 response
Measured: Days 1, 29, 57 and 85
Duration of therapeutic FEV1 response
Measured: Days 1, 29, 57 and 85
Time to peak FEV1 response
Measured: Days 1, 29, 57 and 85
TAUC0-6, TAUC0-8 and peak FVC (Forced vital capacity)
Measured: Days 1, 29, 57 and 85
Amount of beta agonist therapy used as rescue medication during the treatment period
Measured: up to day 85
Number of patients using concomitant medication including corticosteroids during the treatment period
Measured: up to day 85
Weekly means of daily symptom scores over the treatment period
Measured: up to day 85
Number of patients with at least one COPD exacerbation
Measured: up to day 85
Number of COPD exacerbations during the treatment period
Measured: up to day 85
Physician's Global Evaluation
Measured: Days 1, 29, 57 and 85
Trough PEFR (peak expiratory flow rate) measured by the patient at home once daily
Measured: up to day 85
Number of patients with adverse events
Measured: up to day 85
Incidence of paradoxical bronchoconstriction on the test day
Measured: up to day 85
Number of COPD exacerbation days
Measured: up to day 85
Number of patients with clinically significant changes in vital signs
Measured: Baseline, days 1, 29, 57 and 85
Number of patients with abnormal changes in laboratory parameters
Measured: Days 29 and 85
Number of patients with abnormal changes in 12-lead electrocardiogram (ECG) parameters
Measured: pre-treatment and 1 hour post-treatment on days 1, 29 and 85
Plasma ipratropium and salbutamol concentrations
Measured: pre-treatment, 5, 15, 30 and 60 minutes and 2, 4 and 8 hours after inhalation of test drug on day 29
Renal excretion amounts of ipratropium and salbutamol
Measured: 0-2 hours, 2-8 hours at day 29
Length of COPD exacerbations during the treatment period
Measured: up to day 85

Timeline

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

Oct 2002Mar 2004

First posted27 Jun 2014 (estimated)
Study startOct 2002
Primary completionMar 2004

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 1,118 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02177253
Sponsor's protocol ID: 1012.46
Status last verified: Jun 2014
First submitted: 20 Jun 2014
Last updated: 27 Jun 2014
Results posted: No

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?

Official record

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A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
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All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparison of Ipratropium Bromide/Salbutamol (40 mcg / 200 mcg, One Inhalation) Delivered by the Respimat ® Inhaler to COMBIVENT Inhalation Aerosol (Two Inhalations), Ipratropium Bromide Respimat ® and Placebo of Each Formulation in a 12-week, Double-blind, Safety and Efficacy Study in Adults With Chronic Obstructive Pulmonary Disease
ClinicalTrials.gov ID: NCT02177253
Acronym / sponsor ID: 1012.46
Conditions: Pulmonary Disease, Chronic Obstructive
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,118 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Oct 2002
Primary completion: Mar 2004 (actual)
First posted: 27 Jun 2014 (estimated)
Results: Not posted in the source record

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: 5

Arm	Type	Receives
Ipratropium bromide / Salbutamol Inhalation solution	Experimental	Drug: Ipratropium bromide / Salbutamol
Placebo Inhalation solution	Placebo comparator	Drug: Placebo Inhalation solution
Ipratropium bromide Inhalation solution	Experimental	Drug: Ipratropium bromide
COMBIVENT Inhalation Aerosol (ipratropium bromide/salbutamol)	Active comparator	Drug: COMBIVENT Inhalation Aerosol
Placebo Inhalation Aerosol	Placebo comparator	Drug: Placebo Inhalation Aerosol

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

All patients must have a diagnosis of COPD and the following spirometric criteria:
Male or female patients 40 years of age or older
Patients must have a smoking history of more than ten pack-years. A pack-year is defined as the equivalent of smoking one pack of 20 cigarettes per day for a year
Patients must be able to perform pulmonary function tests and maintain records during the study period as required in the protocol
Patients must be able to be trained in the proper use of an MDI (metered dose inhaler) and the Respimat® inhaler

Key exclusion criteria (27 listed)

Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study
Patients with clinically relevant abnormal baseline hematology, blood chemistry or urinalysis. If the abnormality defines a disease listed as an exclusion criterion, the patient is excluded
All patients with a SGOT (serum glutamic oxaloacetic transaminase) >80 IU/L, SGPT (serum glutamic pyruvic transaminase) >80 IU/L, bilirubin >2.0 mg/dL or creatinine >2.0 mg/dL will be excluded regardless of the clinical condition
Patients who have a total blood eosinophil count ≥600/mm3
Patients with a recent history (i.e., one year or less) of myocardial infarction

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
Ipratropium bromide / Salbutamol	Drug	Ipratropium bromide / Salbutamol Inhalation solution
Placebo Inhalation solution	Drug	Placebo Inhalation solution
Ipratropium bromide	Drug	Ipratropium bromide Inhalation solution
COMBIVENT Inhalation Aerosol	Drug	COMBIVENT Inhalation Aerosol (ipratropium bromide/salbutamol)
Placebo Inhalation Aerosol	Drug	Placebo Inhalation Aerosol

Primary outcome

FEV1 TAUC0-6 (Total area under the FEV1 (forced expiratory volume in one second) curve from 0 to 6 hours divided by six)
Time frame: Day 85

25 secondary outcomes

FEV1 TAUC0-6
Time frame: Days 1, 29 and 57
FEV1 TAUC0-8
Time frame: Days 1, 29, 57 and 85
Peak FEV1 post treatment over two hours
Time frame: Days 1, 29, 57 and 85
Change from baseline in Peak FEV1 response
Time frame: Days 1, 29, 57 and 85
Area under the FEV1 curve from 0 to 6 hours above test-day baseline divided by six for normalization (AUC0-6)
Time frame: Days 1, 29, 57 and 85
Onset of therapeutic FEV1 response
Time frame: Days 1, 29, 57 and 85
Duration of therapeutic FEV1 response
Time frame: Days 1, 29, 57 and 85
Time to peak FEV1 response
Time frame: Days 1, 29, 57 and 85
TAUC0-6, TAUC0-8 and peak FVC (Forced vital capacity)
Time frame: Days 1, 29, 57 and 85
Amount of beta agonist therapy used as rescue medication during the treatment period
Time frame: up to day 85
Number of patients using concomitant medication including corticosteroids during the treatment period
Time frame: up to day 85
Weekly means of daily symptom scores over the treatment period
Time frame: up to day 85
Number of patients with at least one COPD exacerbation
Time frame: up to day 85
Number of COPD exacerbations during the treatment period
Time frame: up to day 85
Physician's Global Evaluation
Time frame: Days 1, 29, 57 and 85
Trough PEFR (peak expiratory flow rate) measured by the patient at home once daily
Time frame: up to day 85
Number of patients with adverse events
Time frame: up to day 85
Incidence of paradoxical bronchoconstriction on the test day
Time frame: up to day 85
Number of COPD exacerbation days
Time frame: up to day 85
Number of patients with clinically significant changes in vital signs
Time frame: Baseline, days 1, 29, 57 and 85
Number of patients with abnormal changes in laboratory parameters
Time frame: Days 29 and 85
Number of patients with abnormal changes in 12-lead electrocardiogram (ECG) parameters
Time frame: pre-treatment and 1 hour post-treatment on days 1, 29 and 85
Plasma ipratropium and salbutamol concentrations
Time frame: pre-treatment, 5, 15, 30 and 60 minutes and 2, 4 and 8 hours after inhalation of test drug on day 29
Renal excretion amounts of ipratropium and salbutamol
Time frame: 0-2 hours, 2-8 hours at day 29
Length of COPD exacerbations during the treatment period
Time frame: up to day 85

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2014.
Related InfoLink provided by the sponsor.

Related trials for Pulmonary Disease, Chronic Obstructive

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
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Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ipratropium bromide / Salbutamol, Ipratropium bromide and COMBIVENT Inhalation Aerosol in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.

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 7 inclusion and 27 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 27 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

FEV1 TAUC0-6 (Total area under the FEV1 (forced expiratory volume in one second) curve from 0 to 6 hours divided by six) (time frame: Day 85). 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 NCT02177253.

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 27 Jun 2014.