- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02176187
Berodual® Respimat® vs Metered Dose Inhaler in Patients With Chronic Obstructive Pulmonary Disease
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
- 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
Exclusion Criteria:
- 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
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: natural technique, without instructions
randomised sequence of Berodual® Respimat® and Berodual® MDI
|
fenoterol hydrobromide 50μg + ipratropium bromide 20μg
fenoterol hydrobromide 50μg + ipratropium bromide 20μg
|
Experimental: optimal technique, with instructions
randomised sequence of Berodual® Respimat® and Berodual® MDI
|
fenoterol hydrobromide 50μg + ipratropium bromide 20μg
fenoterol hydrobromide 50μg + ipratropium bromide 20μg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of dose in the whole lung
Time Frame: immediately after dosing
|
Deposition of aerosol via gamma scintigraphy
|
immediately after dosing
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of dose in the central lung zone
Time Frame: immediately after dosing
|
Deposition of aerosol via gamma scintigraphy
|
immediately after dosing
|
Percentage of dose in the intermediate lung zone deposition
Time Frame: immediately after dosing
|
Deposition of aerosol via gamma scintigraphy
|
immediately after dosing
|
Percentage of dose in the peripheral lung zone deposition
Time Frame: immediately after dosing
|
Deposition of aerosol via gamma scintigraphy
|
immediately after dosing
|
Peripheral lung zone/central lung zone deposition ratio (lung penetration index)
Time Frame: immediately after dosing
|
Deposition of aerosol via gamma scintigraphy
|
immediately after dosing
|
Percentage of dose in oropharyngeal deposition
Time Frame: immediately after dosing
|
Deposition of aerosol via gamma scintigraphy
|
immediately after dosing
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Antagonists
- Cholinergic Agents
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Reproductive Control Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Tocolytic Agents
- Sympathomimetics
- Ipratropium
- Fenoterol
- Fenoterol, ipratropium drug combination
Other Study ID Numbers
- 215.1360
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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