Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00153075
Status:
COMPLETED
Last Update Posted:
2023-11-29
First Post:
2005-09-09
Brief Title:
Flow Rate Effect Respimat Inhaler Versus a Metered Dose Inhaler Using Berodual in Patients With Chronic Obstructive Pulmonary Disease COPD
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
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 Inhaler vs a Metered Dose Inhaler HFA-MDI Using Berodual in Patients With Chronic Obstructive Pulmonary Disease COPD
Status:
COMPLETED
Status Verified Date:
2023-11
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 at 3 different inspiratory flow rates following inhalation of Berodual delivered via the Respimat inhaler and Berodual delivered via an HFA-metered dose inhaler
Detailed Description:
This is a single dose randomised active-controlled six period open-label cross-over trial in adult patients with COPD
Berodual fenoterol hydrobromide 50 g ipratropium bromide 20 g will be delivered via the Respimat inhaler and the MDI at 3 different inspiratory flow rates 15 Lmin 30 Lmin and 90 Lmin The optimal flow rate is expected to be 30 Lmin for both inhalers
On each test day patients will practise the inhalation manoeuvre with either a placebo Respimat or MDI inhaler When patients can perform the inhalation technique correctly and they can obtain the required inspiratory flow rates the placebo will be replaced with the radio-labelled formulation
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 flow rate has the same effect on the Respimat and MDI inhalers The alternative hypothesis is that flow rate has a different effect on the Respimat inhaler than on the MDI inhaler
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 lik ely 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
For the primary comparison the whole lung deposition achieved for each patient at the 90 Lmin flow rate will be expressed as a percentage of the whole lung deposition achieved by that patient at the 30 Lmin flow rate for the Respimat and MDI inhalers separately The difference between each pair of observations Respimat 90 Lmin Respimat 30 Lmin - MDI 90 Lmin MDI 30 Lmin will then be calculated and the sign of the direction of the difference noted ie positive or negative The probability associated with the occurrence of the observed number of positive and negative differences will then be determined by reference to the binomial distribution with the probability of a positive or negative difference equal to 05 under the null hypothesis If the alternative hypothesis is however true and flow rate does in fact have less effect on the Respimat inhaler than on the MDI inhaler then there is likely to be a statistically significant greater number of positive differences
Berodual fenoterol hydrobromide 50 g ipratropium bromide 20 g will be delivered via the Respimat inhaler and the MDI at 3 different inspiratory flow rates 15 Lmin 30 Lmin and 90 Lmin The optimal flow rate is expected to be 30 Lmin for both inhalers
On each test day patients will practise the inhalation manoeuvre with either a placebo Respimat or MDI inhaler When patients can perform the inhalation technique correctly and they can obtain the required inspiratory flow rates the placebo will be replaced with the radio-labelled formulation
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 flow rate has the same effect on the Respimat and MDI inhalers The alternative hypothesis is that flow rate has a different effect on the Respimat inhaler than on the MDI inhaler
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 lik ely 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
For the primary comparison the whole lung deposition achieved for each patient at the 90 Lmin flow rate will be expressed as a percentage of the whole lung deposition achieved by that patient at the 30 Lmin flow rate for the Respimat and MDI inhalers separately The difference between each pair of observations Respimat 90 Lmin Respimat 30 Lmin - MDI 90 Lmin MDI 30 Lmin will then be calculated and the sign of the direction of the difference noted ie positive or negative The probability associated with the occurrence of the observed number of positive and negative differences will then be determined by reference to the binomial distribution with the probability of a positive or negative difference equal to 05 under the null hypothesis If the alternative hypothesis is however true and flow rate does in fact have less effect on the Respimat inhaler than on the MDI inhaler then there is likely to be a statistically significant greater number of positive differences
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