Evaluation of the Respimat Inhaler vs. a HFA MDI Using Berodual in Patients With COPD With Poor MDI Technique.
|First Received Date ICMJE||December 21, 2005|
|Last Updated Date||May 18, 2012|
|Start Date ICMJE||Not Provided|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||The primary endpoint is the percentage of lung deposition achieved with natural inhaler technique compared with supervised optimal administration.|
|Original Primary Outcome Measures ICMJE
||The primary endpoint is the percentage of lung deposition achieved with "natural" inhaler technique compared with supervised "optimal" administration.|
|Change History||Complete list of historical versions of study NCT00267917 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||The ""natural"" inhalation technique and supervised ""optimal"" inhalation techniques will be compared for Respimat inhaler and the MDI in terms of: Central lung zone deposition Intermediate lung zone deposition Peripheral lung zone deposition|
|Original Secondary Outcome Measures ICMJE
||The "natural" inhalation technique and supervised "optimal" inhalation techniques will be compared for Respimat® inhaler and the MDI in terms of: o Central lung zone deposition o Intermediate lung zone deposition o Peripheral lung zone deposition|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Evaluation of the Respimat Inhaler vs. a HFA MDI Using Berodual in Patients With COPD With Poor MDI Technique.|
|Official Title ICMJE||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.|
The objective of this trial is to compare the total and regional deposition of aerosol in the lungs and oropharynx of patients with COPD and known poor MDI inhalation technique following inhalation of Berodual? delivered via the Respimat? inhaler and Berodual? delivered via an HFA-metered dose inhal er achieved with their "natural" inhalation technique compared with taught "optimal" technique.
This is a single dose, randomised, active-controlled, four period, open-label cross-over trial in ad ult patients with COPD who have demonstrated a poor MDI technique. Berodual? (fenoterol hydrobromide 50 ?g + ipratropium bromide 20 ?g) will be delivered via the Respi mat? inhaler on two test days and via the MDI on two test days. Test days with no instruction on correct usage will occur prior to the test days with taught techniq ue, so that the patient's own technique will not be influenced by recent instruction.
Each device will thus first be used with no instructions on correct device use provided. On these no instruction test days each device will be demonstrated and patients will be allowed time to practis e on their own with a placebo device. The second time each device is used full instructions will be provided on the correct usage with pat ients practising with placebo either from the Respimat? inhaler or from the MDI until they are judge d competent. On these two test days the Respimat? or MDI inhalers will be fired by the investigator one second after the patient has started to inhale. Thus on Test Days 1 and 2 patients will use their own natural inhalation technique without receiving any instruction on correct usage. On Test Days 3 and 4 patients will use a supervised optimal techn ique having received instruction on correct usage and with the investigator firing the device.
The primary analysis will be carried out using the Sign Test. This is a non-parametric analysis in w hich no assumptions are made about the shape of the distribution of the responses from the Respimat? inhaler and from the MDI under the null hypothesis.
The null hypothesis is that poor technique has the same effect on the Respimat? and MDI devices. The alternative hypothesis is that poor technique has a differe nt effect on the Respimat? inhaler than on the MDI. This means that under the null hypothesis the median of the differences between the Respimat? inhaler and MDI pairs is zero i.e. the differences are equally lik ely to be positive or negative. Under the alternative hypothesis the median of t he differences between the Respimat? inhaler and MDI pairs is not zero i.e. the frequencies of the positive and negative signs are different.
Baseline comparability will be achieved by the use of a cross-over trial design with every patient receiving all four treatments and by ensuring at each test da y that baseline lung function is within 15% of the value obtained at the first t est day, pre-dose FEV1 is < 65% of predicted value and patients have abstained f rom inhaled bronchodilators for at least 4 hours prior to the visit. Treatment s equence will not be fitted as a term in the analysis of variance models.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||February 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
COPD patients: FEV1 less or equal 65% pre FEV1 less or equal 70% of FVC
Patients with any upper respiratory infection in the past 14 days prior to the s creening visit (visit 1) Patients with any unstable or life-threatening cardiac arrhythmia
|Ages||40 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Germany|
|NCT Number ICMJE||NCT00267917|
|Other Study ID Numbers ICMJE||215.1365|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Boehringer Ingelheim Pharmaceuticals|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Boehringer Ingelheim Pharmaceuticals|
|Verification Date||May 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP