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(R) inhaler vs a Metered Dose Inhaler (HFA-MDI) using Berodural(R) in patients with Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD) is characterised by airflow limitation and bronchial inflammation. Clinically, COPD is characterised by progressive dyspnoea on exertion and intermittent exacerbations, usually precipitated by infection. Airflow limitation results from one or more different processes including smooth muscle spasm, mucosal oedema, loss of elastic recoil, inspissated mucus and cellular debris in airway lumen, and thickening of the bronchial wall.MedDRA version: 8.0Level: LLTClassification code 10010952
- Registration Number
- EUCTR2005-000841-12-DE
- Lead Sponsor
- Boehringer Ingelheim Pharma GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 18
Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 <=65% of predicted normal and FEV1 <=70% of FVC.
Current or ex-smokers with a smoking history of >=10 pack years.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Patients who have frequent exacerbations which could be expected to interfere with the patients ability to participate in the trial should be excluded. The enrolment of patients who have had an exacerbation within the six weeks prior to planned study entry should be postponed.
Patients with a recent history (i.e. six months or less) of myocardial infarction.
Patients with any unstable or life-treatening cardiac arrhythmia or who have been hospitalised for heart failure within the past years.
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.
Patiens with a history of cancer within the last five years. Patients with treated basal cell carcinoma are allowed.
Patients with any upper respiratory infection in the past 14 days prior to the Screnning Visit (Visit 1) or during the baseline period or lower respiratory tract infection within the last 3 months.
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 thant 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 have taken an investigational drug within 30 days or six half lives (whichever is the greater) prior to Screening Visit (Visit 1) and/or the administration of radio-labelled dosage forms (within a clinical trial) within the calendar year.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this trial is to compare the total and regional deposition of aerosol in the lungs and oropharynx of patients with COPD at 3 different inspiratory flow rates following inhalation of Berodual® delivered via the Respimat® inhaler and Berodual® delivered via an HFA-metered dose inhaler.<br><br>The primary endpoint is whole lung deposition.;Secondary Objective: The Respimat® inhaler will also be compared with the MDI in terms of<br>- Central lung zone deposition<br>- Intermediate lung zone deposition<br>- Peripheral lung zone deposition<br>- Ratio of peripheral to central zone deposition<br>- Oropharyngeal deposition<br>- Device deposition and exhaled air filter deposition<br>- FEV1 15, 30 and 60 minutes post administration (safety only);Primary end point(s): The primary endpoint is whole lung deposition.
- Secondary Outcome Measures
Name Time Method