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AzTrials

Pulmonary Disease, Chronic ObstructivePhase 3NCT02176200

Respimat® Inhaler vs a Metered Dose Inhaler Using Berodual® in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 3 study testing Berodual® Respimat®, low inspiratory flow rate, Berodual® Respimat®, medium inspiratory flow rate and Berodual® Respimat®, high inspiratory flow rate in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Study to compare the lung and oropharyngeal deposition of Berodual® (fenoterol hydrobromide 50μg + ipratropium bromide 20μg /1x puff) delivered via the Respimat® inhaler and the same dose of Berodual® delivered via an hydrofluoroalkane (HFA) - metered dose inhaler (2 x puffs ) in COPD patients at different inspiratory… 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®, low inspiratory flow rate, Berodual® Respimat®, medium inspiratory flow rate and Berodual® Respimat®, high inspiratory flow rate
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 volume 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)
  • Male or non-pregnant/non-lactating female patients aged ≥18 years
  • 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 who have frequent exacerbations which could be expected to interfere with the patient's ability to participate in the study should be excluded. The enrolment of patients who have had an exacerbation within the six weeks prior to planned study entry has to be postponed.
  • 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 therapy
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  • Patients with known active tuberculosis
  • 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 or lower respiratory tract infection within the last 3 months
  • 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 cromolyn sodium or nedocromil sodium
  • 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, Six Way, Cross-over Scintigraphic Evaluation of the Effect of Inspiratory Flow Rate on Lung and Oropharyngeal Deposition With the Respimat® Inhaler vs a Metered Dose Inhaler (HFA-MDI) Using Berodual® in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Study to compare the lung and oropharyngeal deposition of Berodual® (fenoterol hydrobromide 50μg + ipratropium bromide 20μg /1x puff) delivered via the Respimat® inhaler and the same dose of Berodual® delivered via an hydrofluoroalkane (HFA) - metered dose inhaler (2 x puffs ) in COPD patients at different inspiratory flow rates.

Being tested
Berodual® Respimat®, low inspiratory flow rate, Berodual® Respimat®, medium inspiratory flow rate, Berodual® Respimat®, high inspiratory flow rate, Berodual® HFA-MDI, low inspiratory flow rate, Berodual® HFA-MDI, medium inspiratory flow rate
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®, low inspiratory flow rateDrug

  • Berodual® Respimat®, medium inspiratory flow rateDrug

  • Berodual® Respimat®, high inspiratory flow rateDrug

  • Berodual® HFA-MDI, low inspiratory flow rateDrug

  • Berodual® HFA-MDI, medium inspiratory flow rateDrug

  • Berodual® HFA-MDI, high inspiratory flow rateDrug

Study groups in NCT02176200
Study groupRoleWhat they receive
Berodual® Respimat®ExperimentalNot described
Receives: Drug: Berodual® Respimat®, low inspiratory flow rate; Drug: Berodual® Respimat®, medium inspiratory flow rate; Drug: Berodual® Respimat®, high inspiratory flow rate; Drug: Berodual® HFA-MDI, low inspiratory flow rate; Drug: Berodual® HFA-MDI, medium inspiratory flow rate; Drug: Berodual® HFA-MDI, high inspiratory flow rate
Berodual® HFA-MDIActive comparatorNot described
Receives: Drug: Berodual® Respimat®, low inspiratory flow rate; Drug: Berodual® Respimat®, medium inspiratory flow rate; Drug: Berodual® Respimat®, high inspiratory flow rate; Drug: Berodual® HFA-MDI, low inspiratory flow rate; Drug: Berodual® HFA-MDI, medium inspiratory flow rate; Drug: Berodual® HFA-MDI, high inspiratory flow rate

What is being measured

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

  1. Percentage of dose in the whole lung

    disposition of aerosol via gamma scintigraphy

    Measured: immediately after dosing

Secondary outcomes (5)

  1. Percentage of dose in the central lung zone

    disposition of aerosol via gamma scintigraphy

    Measured: immediately after dosing

  2. Percentage of dose in the intermediate lung zone

    disposition of aerosol via gamma scintigraphy

    Measured: immediately after dosing

  3. Percentage of dose in the peripheral lung zone

    disposition of aerosol via gamma scintigraphy

    Measured: immediately after dosing

  4. Peripheral zone/central zone deposition ratio (lung penetration index)

    disposition of aerosol via gamma scintigraphy

    Measured: immediately after dosing

  5. Percentate of dose in oropharyngeal deposition

    disposition 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.

  1. First posted27 Jun 2014 (estimated)
  2. Study startApr 2003
  3. Primary completionDec 2004

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02176200
Sponsor's protocol ID
215.1361
Status last verified
Jul 2014
First submitted
24 Jun 2014
Last updated
14 Jul 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Berodual® Respimat®, low inspiratory flow rate, Berodual® Respimat®, medium inspiratory flow rate and Berodual® Respimat®, high inspiratory flow rate 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 5 inclusion and 23 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?

On the ClinicalTrials.gov record for NCT02176200.

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.

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