Pulmonary Disease, Chronic ObstructivePhase 3NCT02173782

Comparison of Safety and Efficacy of Berodual® Administered Via the Respimat® Device With That Administered Via the Metered Dose Inhaler (MDI) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 3 study testing Berodual® Respimat ® high dose, Berodual® Respimat ® low dose and Berodual® MDI 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?: Berodual® Respimat ® high dose, Berodual® Respimat ® low dose and Berodual® MDI
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 892 participants
Where: No sites listed yet
Study dates: Feb 1998to Apr 1999
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

Age >= 40 years
Diagnosis of COPD according the following criteria:
screening FEV1<= 65% predicted
Screening FEV1/FVC <= 70%
Smoking history > 10 pack-years (a pack-year is 20 cigarettes per day for one year or equivalent
Able to be trained in the proper use of MDI and Respimat®
Able to be trained in the performance of technically satisfactory pulmonary function tests
All patients must be willing and able to sign informed consent in accordance with Good clinical Practice (GCP) and local legislation

Who cannot join

History of cardiovascular, renal, neurologic, liver or endocrine dysfunction (e.g. hyperthyreosis) if they are clinically significant. A clinically significant disease is defined as one 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 or the study or the patient's ability to participate in the study
Patients with a recent (<= one year) history of myocardial infarction
Tuberculosis with indication for treatment
History of cancer within the last five years (excluding basal carcinoma)
Patients who have undergone thoracotomy
Current psychiatric disorders

Show all 26Show fewer

History of life-threatening pulmonary obstruction, cystic fibrosis or bronchiectasis
An upper and lower respiratory tract infection in the four weeks prior to the screening visit
Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction
Patients with known narrow-angle glaucoma or raised intra-ocular pressure
Patients with clinically significant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a disease listed as an exclusion criterion
Patients with:
Serum glutamic oxalo-acetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) >200% of the upper limit of the normal range
Bilirubin >150% of the upper limit of the normal range
Creatinine >125% of the upper limit of the normal range
Patients who are on chronic oxygen therapy
Intolerance to aerosolised ipratropium- or fenoterol-containing products, or hypersensitivity to any of the MDI ingredients
Oral corticosteroid mediation at dose greater than 10 mg prednisolone per day or equivalent
Beta-blocker medication
Changes in the pulmonary therapeutic plan within the last four weeks prior to the screening visit (not including withholding of medication before the screening visit)
Concomitant or recent (within the last month) use of investigational drugs
History of drug abuse and/or alcoholism
Pregnant or nursing women and women of child-bearing potential not using a medically approved means of contraception
Previous participation in this study (i.e. having been allocated a randomized treatment number)
Patients with a history of asthma, allergic rhinitis or atopy or who have blood eosinophil count above 600/mm3 (a repeat eosinophil count will not be conducted in these patients) and those patients on antihistamines, anti-leukotrienes, sodium cromoglycate or nedocromil sodium
Patients who are unable to comply with the medication restrictions specified in section 4.2 or who cannot use an MDI without a spacer

About this study

Official title: A Randomized, Placebo-controlled, Within-device, Double-blind Tri-national Study to Compare the Safety and Efficacy of Berodual® Administered Via the Respimat® Device (50 µg Fenoterol Hydrobromide/20 µg Ipratropium Bromide and 25 µg Fenoterol Hydrobromide/10 µg Ipratropium Bromide, 1 Puff q.i.d) With That Administered Via the MDI (50 µg Fenoterol Hydrobromide/21 µg Ipratropium Bromide, 2 Puffs q.i.d) in COPD Patients Over a 12-week Period

To demonstrate that at least one of the two doses of Berodual® (50 µg fenoterol hydrobromide/20 µg ipratropium bromide and 25 µg fenoterol hydrobromide/10 µg ipratropium bromide, 1 puff q.i.d) administered via the Respimat® gives a bronchodilator response which is not inferior to that obtained from one dose of Berodual® (50 µg fenoterol hydrobromide/21 µg ipratropium bromide, 2 puffs q.i.d) administered via the MDI and that the safety profile is at least as good when COPD patients are treated for 12 weeks.

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Berodual® Respimat ® high dose, Berodual® Respimat ® low dose, Berodual® MDI, Placebo
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.

Berodual® Respimat ® high doseDrug
Berodual® Respimat ® low doseDrug
Berodual® MDIDrug
PlaceboDrug

Study groups in NCT02173782
Study group	Role	What they receive
Berodual® Respimat ® high dose	Experimental	Not described Receives: Drug: Berodual® Respimat ® high dose
Berodual® MDI	Active comparator	Not described Receives: Drug: Berodual® MDI
Berodual® Respimat® low dose	Experimental	Not described Receives: Drug: Berodual® Respimat ® low dose
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.

Average forced expiratory volume in one second (FEV1) between 0 and 1 hour (Area under the curve (AUC0-1h)) in litres
Measured: after 12 weeks of treatment

Secondary outcomes (13)

Average (FEV1) between 0 and 1 hour (AUC0-1h) in litres on previous test days
Measured: on day 1, 29, 57
Forced vital capacity (FVC) in litres measured at the same time as FEV1
Measured: on day 1, 29, 57 and 85
Peak FEV1 between 0 and 1 hour post inhalation of study drug
Measured: on day 1 and 85
Onset of bronchodilatory response
Linear interpolation of the time of the first therapeutic response and the observation just prior to to the first therapeutic response. Therapeutic response was defined as FEV1 measurement exceeding 1.15 times of the pre-dose value that was recorded at any time point during the one hour observation period.
Measured: on day 1 and 85
Peak expiratory flow (PEF) measured pre-medication, morning and evening, averaged weekly
Measured: up to 12 weeks
Symptom scores recorded on the patient diary card
Measured: up to 12 weeks
Use of rescue bronchodilator medication
Measured: up to 12 weeks
Number of patients with adverse events
Measured: up to 12 weeks
Total average FEV1 (TAUC0-1h)
Measured: day 85
Number of patients with clinically significant changes in vital signs
Measured: up to 12 weeks
Number of patients with clinically significant changes in laboratory parameters
Measured: Baseline and day 85
Number of patients with abnormal findings in physical examination
Measured: Baseline and day 85
Number of patients with clinically significant changes in electrocardiogram
Measured: Baseline and day 85

Timeline

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

Feb 1998Apr 1999

First posted25 Jun 2014 (estimated)
Study startFeb 1998
Primary completionApr 1999

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: 892 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02173782
Sponsor's protocol ID: 215.1349
Status last verified: Jun 2014
First submitted: 24 Jun 2014
Last updated: 14 Jul 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

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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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
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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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RecruitingPhase 3
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
Chronic Graft Versus Host Disease

All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Placebo-controlled, Within-device, Double-blind Tri-national Study to Compare the Safety and Efficacy of Berodual® Administered Via the Respimat® Device (50 µg Fenoterol Hydrobromide/20 µg Ipratropium Bromide and 25 µg Fenoterol Hydrobromide/10 µg Ipratropium Bromide, 1 Puff q.i.d) With That Administered Via the MDI (50 µg Fenoterol Hydrobromide/21 µg Ipratropium Bromide, 2 Puffs q.i.d) in COPD Patients Over a 12-week Period
ClinicalTrials.gov ID: NCT02173782
Acronym / sponsor ID: 215.1349
Conditions: Pulmonary Disease, Chronic Obstructive
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 892 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Feb 1998
Primary completion: Apr 1999 (actual)
First posted: 25 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: 4

Arm	Type	Receives
Berodual® Respimat ® high dose	Experimental	Drug: Berodual® Respimat ® high dose
Berodual® MDI	Active comparator	Drug: Berodual® MDI
Berodual® Respimat® low dose	Experimental	Drug: Berodual® Respimat ® low dose
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

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

Key inclusion criteria (8 listed)

Age >= 40 years
Diagnosis of COPD according the following criteria:
Smoking history > 10 pack-years (a pack-year is 20 cigarettes per day for one year or equivalent
Able to be trained in the proper use of MDI and Respimat®
Able to be trained in the performance of technically satisfactory pulmonary function tests

Key exclusion criteria (26 listed)

History of cardiovascular, renal, neurologic, liver or endocrine dysfunction (e.g. hyperthyreosis) if they are clinically significant. A clinically significant disease is defined as one 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 or the study or the patient's ability to participate in the study
Patients with a recent (<= one year) history of myocardial infarction
Tuberculosis with indication for treatment
History of cancer within the last five years (excluding basal carcinoma)
Patients who have undergone thoracotomy

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
Berodual® Respimat ® high dose	Drug	Berodual® Respimat ® high dose
Berodual® Respimat ® low dose	Drug	Berodual® Respimat® low dose
Berodual® MDI	Drug	Berodual® MDI
Placebo	Drug	Placebo

Primary outcome

Average forced expiratory volume in one second (FEV1) between 0 and 1 hour (Area under the curve (AUC0-1h)) in litres
Time frame: after 12 weeks of treatment

13 secondary outcomes

Average (FEV1) between 0 and 1 hour (AUC0-1h) in litres on previous test days
Time frame: on day 1, 29, 57
Forced vital capacity (FVC) in litres measured at the same time as FEV1
Time frame: on day 1, 29, 57 and 85
Peak FEV1 between 0 and 1 hour post inhalation of study drug
Time frame: on day 1 and 85
Onset of bronchodilatory response
Time frame: on day 1 and 85
Peak expiratory flow (PEF) measured pre-medication, morning and evening, averaged weekly
Time frame: up to 12 weeks
Symptom scores recorded on the patient diary card
Time frame: up to 12 weeks
Use of rescue bronchodilator medication
Time frame: up to 12 weeks
Number of patients with adverse events
Time frame: up to 12 weeks
Total average FEV1 (TAUC0-1h)
Time frame: day 85
Number of patients with clinically significant changes in vital signs
Time frame: up to 12 weeks
Number of patients with clinically significant changes in laboratory parameters
Time frame: Baseline and day 85
Number of patients with abnormal findings in physical examination
Time frame: Baseline and day 85
Number of patients with clinically significant changes in electrocardiogram
Time frame: Baseline and 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 14 Jul 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
COPD, Smoking
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
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RecruitingPhase 3
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 Berodual® Respimat ® high dose, Berodual® Respimat ® low dose and Berodual® MDI 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 8 inclusion and 26 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 14 Jul 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?

Average forced expiratory volume in one second (FEV1) between 0 and 1 hour (Area under the curve (AUC0-1h)) in litres (time frame: after 12 weeks of treatment). 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 NCT02173782.

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 14 Jul 2014.