Pulmonary Disease, Chronic Obstructive
Conditions
Brief 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
Interventions
DRUGBerodual® Respimat® inhaler
fenoterol hydrobromide 50μg + ipratropium bromide 20μg
DRUGBerodual® metered dose inhaler
fenoterol hydrobromide 50μg + ipratropium bromide 20μg
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of dose in the whole lung | immediately after dosing | Deposition of aerosol via gamma scintigraphy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of dose in the peripheral lung zone deposition | immediately after dosing | Deposition of aerosol via gamma scintigraphy |
| Peripheral lung zone/central lung zone deposition ratio (lung penetration index) | immediately after dosing | Deposition of aerosol via gamma scintigraphy |
| Percentage of dose in the central lung zone | immediately after dosing | Deposition of aerosol via gamma scintigraphy |
| Percentage of dose in the intermediate lung zone deposition | immediately after dosing | Deposition of aerosol via gamma scintigraphy |
| Percentage of dose in oropharyngeal deposition | immediately after dosing | Deposition of aerosol via gamma scintigraphy |
Outcome results
None listed