Pulmonary Disease, Chronic ObstructivePhase 3NCT02176187
Berodual® Respimat® vs Metered Dose Inhaler in Patients With Chronic Obstructive Pulmonary Disease
A Phase 3 study testing Berodual® Respimat® inhaler and Berodual® metered dose inhaler in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
Trial summary
Study to compare the effect of 'natural' as opposed to 'optimal' technique on the percentage of the dose received from the Respimat® inhaler and metered dose inhaler Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Berodual® Respimat® inhaler and Berodual® metered dose inhaler
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- Apr 2003to Dec 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 18 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 must meet the following spirometric criteria:
- Patients must have relatively stable, mild to severe airway obstruction with an forced expiratory volulme in one second (FEV1) ≤70% of predicted normal and FEV1 ≤70% of forced vital capacity (FVC). Predicted normal values calculated according to evolutionary conserved chromosome segments (ECCS)
- Patients who have frequent exacerbations which could be expected to interfere with the patient's ability to participate in the study should be excluded
- Male or non-pregnant/non-lactating female patients aged ≥18 years
- Patients must demonstrate poor MDI technique prior to the start of the study. Presence of any of the following will be considered poor technique:
- Failure to co-ordinate "firing" of an MDI with inhalation
Show all 10Show fewer
- Too fast an inhalation rate (> 30 litres/minute (L/min))
- Presence of "Cold Freon" effect (MDI spray hitting the back of the throat that caused the patient to stop inhaling)
- All patients must sign an informed consent form prior to participation in the study, i.e. prior to pre-study washout of their usual pulmonary medications
- Current or ex-smokers with a smoking history of >10 pack years
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 haematology, blood chemistry or urinalysis, if the abnormality defines a disease listed as an exclusion criterion will be excluded
- Patients with a recent history (i.e. six months or less) of myocardial infarction
- Patients with any unstable or life-threatening cardiac arrhythmia or who have been hospitalised for heart failure within the past year
- Patients who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen
- Patients with known active tuberculosis
Show all 21Show fewer
- Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma are allowed
- Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis
- Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion 1
- Patients with any upper respiratory infection in the past 14 days prior to the screening visit or during the baseline period
- Patients who are currently in a pulmonary rehabilitation programme or who have completed a pulmonary rehabilitation programme in the six weeks prior to the screening visit
- Patients with known hypersensitivity to β2-agonists, anticholinergic drugs or any excipients of the active or placebo Berodual®
- Patients with known narrow-angle glaucoma
- Patients who are being treated with antihistamines (H1 receptor antagonists)
- Patients using oral corticosteroid medication at unstable doses (i.e. less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisolone per day or 20 mg every other day
- Patients who are being treated with monamine oxidase inhibitors or tricyclic antidepressants
- Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e. oral or injectable eg Depo-Provera or Noristerat contraceptives, intrauterine devices, diaphragm (plus spermicide) or subdermal implants eg: Norplant®)
- Patients with, in the opinion of the investigator, a history of and/or active significant alcohol or drug abuse
- Patients who have taken an investigational drug within four months or six half lives (whichever is the greater) prior to screening visit and/or the administration of radiolabelled dosage forms within the three months prior to the screening visit
- Radiation exposure from clinical studies, including that from the present study and diagnostic X-rays but excluding background radiation, exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last five years. No patient whose occupational exposure is monitored will participate in the study
- Precautions: As with other anticholinergic drugs, Berodual® should be used with caution in patients with prostatic hyperplasia or bladder neck obstruction.
About this study
Official title: A Randomised Open Label, Four Way, Cross-over Scintigraphic Evaluation of the Respimat® Inhaler vs a Metered Dose Inhaler (HFA-MDI) Using Berodual® in Patients With Chronic Obstructive Pulmonary Disease (COPD) With Poor MDI Technique
Study to compare the effect of 'natural' as opposed to 'optimal' technique on the percentage of the dose received from the Respimat® inhaler and metered dose inhaler
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Berodual® Respimat® inhaler, Berodual® metered dose inhaler
- 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® inhalerDrug
fenoterol hydrobromide 50μg + ipratropium bromide 20μg
Berodual® metered dose inhalerDrug
fenoterol hydrobromide 50μg + ipratropium bromide 20μg
| Study group | Role | What they receive |
|---|---|---|
| natural technique, without instructions | Experimental | randomised sequence of Berodual® Respimat® and Berodual® MDI Receives: Drug: Berodual® Respimat® inhaler; Drug: Berodual® metered dose inhaler |
| optimal technique, with instructions | Experimental | randomised sequence of Berodual® Respimat® and Berodual® MDI Receives: Drug: Berodual® Respimat® inhaler; Drug: Berodual® metered dose inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of dose in the whole lung
Deposition of aerosol via gamma scintigraphy
Measured: immediately after dosing
Secondary outcomes (5)
Percentage of dose in the central lung zone
Deposition of aerosol via gamma scintigraphy
Measured: immediately after dosing
Percentage of dose in the intermediate lung zone deposition
Deposition of aerosol via gamma scintigraphy
Measured: immediately after dosing
Percentage of dose in the peripheral lung zone deposition
Deposition of aerosol via gamma scintigraphy
Measured: immediately after dosing
Peripheral lung zone/central lung zone deposition ratio (lung penetration index)
Deposition of aerosol via gamma scintigraphy
Measured: immediately after dosing
Percentage of dose in oropharyngeal deposition
Deposition of aerosol via gamma scintigraphy
Measured: immediately after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startApr 2003
- Primary completionDec 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02176187
- Sponsor's protocol ID
- 215.1360
- Status last verified
- Jul 2014
- First submitted
- 24 Jun 2014
- Last updated
- 14 Jul 2014
- Results posted
- No
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 Randomised Open Label, Four Way, Cross-over Scintigraphic Evaluation of the Respimat® Inhaler vs a Metered Dose Inhaler (HFA-MDI) Using Berodual® in Patients With Chronic Obstructive Pulmonary Disease (COPD) With Poor MDI Technique
- ClinicalTrials.gov ID
- NCT02176187
- Acronym / sponsor ID
- 215.1360
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Primary completion
- Dec 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 to compare the effect of 'natural' as opposed to 'optimal' technique on the percentage of the dose received from the Respimat® inhaler and metered dose inhaler
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| natural technique, without instructions | Experimental | Drug: Berodual® Respimat® inhaler, Drug: Berodual® metered dose inhalerrandomised sequence of Berodual® Respimat® and Berodual® MDI |
| optimal technique, with instructions | Experimental | Drug: Berodual® Respimat® inhaler, Drug: Berodual® metered dose inhalerrandomised sequence of Berodual® Respimat® and Berodual® MDI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- All patients must have a diagnosis of COPD and must meet the following spirometric criteria:
- Male or non-pregnant/non-lactating female patients aged ≥18 years
- Patients must demonstrate poor MDI technique prior to the start of the study. Presence of any of the following will be considered poor technique:
- All patients must sign an informed consent form prior to participation in the study, i.e. prior to pre-study washout of their usual pulmonary medications
- Current or ex-smokers with a smoking history of >10 pack years
Key exclusion criteria (21 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 haematology, blood chemistry or urinalysis, if the abnormality defines a disease listed as an exclusion criterion will be excluded
- Patients with a recent history (i.e. six months or less) of myocardial infarction
- Patients with any unstable or life-threatening cardiac arrhythmia or who have been hospitalised for heart failure within the past year
- Patients who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen
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® inhalerfenoterol hydrobromide 50μg + ipratropium bromide 20μg | Drug | natural technique, without instructions, optimal technique, with instructions |
| Berodual® metered dose inhalerfenoterol hydrobromide 50μg + ipratropium bromide 20μg | Drug | natural technique, without instructions, optimal technique, with instructions |
Primary outcome
Percentage of dose in the whole lung
Time frame: immediately after dosing
Deposition of aerosol via gamma scintigraphy
5 secondary outcomes
Percentage of dose in the central lung zone
Time frame: immediately after dosing
Percentage of dose in the intermediate lung zone deposition
Time frame: immediately after dosing
Percentage of dose in the peripheral lung zone deposition
Time frame: immediately after dosing
Peripheral lung zone/central lung zone deposition ratio (lung penetration index)
Time frame: immediately after dosing
Percentage of dose in oropharyngeal deposition
Time frame: immediately after dosing
Results and safety
The study was stopped early. Results are not available in the source record.
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
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
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
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® inhaler and Berodual® metered dose inhaler 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 10 inclusion and 21 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: stopped early, 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. 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 was stopped early. Results are not available in the source record.
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?
Percentage of dose in the whole lung (time frame: immediately after dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.