Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00267917
Status:
COMPLETED
Last Update Posted:
2023-12-14
First Post:
2005-12-21
Brief Title:
Evaluation of the Respimat Inhaler vs a HFA MDI Using Berodual in Patients With COPD With Poor MDI Technique
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 inhaler achieved with their natural inhalation technique compared with taught optimal technique
Detailed Description:
This is a single dose randomised active-controlled four period open-label cross-over trial in adult patients with COPD who have demonstrated a poor MDI technique Berodual fenoterol hydrobromide 50 μg ipratropium bromide 20 μg will be delivered via the Respimat 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 technique so that the patients 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 practice on their own with a placebo device The second time each device is used full instructions will be provided on the correct usage with patients practicing with placebo either from the Respimat inhaler or from the MDI until they are judged 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 technique 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 which 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
Study 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 different 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 ie the differences are equally likely to be positive or negative Under the alternative hypothesis the median of the differences between the Respimat inhaler and MDI pairs is not zero ie the frequencies of the positive and negative signs are different
Comparisons
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 day that baseline lung function is within 15 of the value obtained at the first test day pre-dose FEV1 is 65 of predicted value and patients have abstained from inhaled bronchodilators for at least 4 hours prior to the visit Treatment sequence will not be fitted as a term in the analysis of variance models
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 practice on their own with a placebo device The second time each device is used full instructions will be provided on the correct usage with patients practicing with placebo either from the Respimat inhaler or from the MDI until they are judged 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 technique 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 which 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
Study 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 different 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 ie the differences are equally likely to be positive or negative Under the alternative hypothesis the median of the differences between the Respimat inhaler and MDI pairs is not zero ie the frequencies of the positive and negative signs are different
Comparisons
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 day that baseline lung function is within 15 of the value obtained at the first test day pre-dose FEV1 is 65 of predicted value and patients have abstained from inhaled bronchodilators for at least 4 hours prior to the visit Treatment sequence will not be fitted as a term in the analysis of variance models
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None