Flow Rate Effect Respimat Inhaler Versus a Metered Dose Inhaler Using Berodual in Patients With Chronic Obstructive Pulmonary Disease (COPD)

November 27, 2023 updated by: Boehringer Ingelheim

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).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 L/min, 30 L/min and 90 L/min. The optimal flow rate is expected to be 30 L/min 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 i.e., 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 i.e., the frequencies of the positive and negative signs are different.

Comparison(s):

For the primary comparison the whole lung deposition achieved for each patient at the 90 L/min flow rate will be expressed as a percentage of the whole lung deposition achieved by that patient at the 30 L/min flow rate for the Respimat and MDI inhalers separately. The difference between each pair of observations ((Respimat 90 L/min / Respimat 30 L/min) - (MDI 90 L/min / MDI 30 L/min)) will then be calculated and the sign of the direction of the difference noted i.e., 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 0.5 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 Type

Interventional

Enrollment

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- - Gauting, Germany, 82131
    - Inamed Research GmbH & Co. KG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

COPD patients:
- FEV1 less or equal 65 % pre
- FEV1 less or equal 70 % of FVC

Exclusion Criteria:

Patients with any upper respiratory infection in the past 14 days prior to the Screening Visit (Visit 1)
Patients with any unstable or life-threatening cardiac arrhythmia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Whole lung deposition Time Frame: 12 weeks	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Central lung zone deposition Time Frame: 12 weeks	12 weeks
Intermediate lung zone deposition Time Frame: 10 weeks	10 weeks
Peripheral lung zone deposition Time Frame: 12 weeks	12 weeks
Ratio of peripheral to central zone deposition Time Frame: 12 weeks	12 weeks
Oropharyngeal deposition Time Frame: 12 weeks	12 weeks
Device deposition and exhaled air filter deposition Time Frame: 12 weeks	12 weeks
FEV1 15, 30 and 60 minutes post-administration (safety only) Time Frame: 12 weeks	12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Investigators

Study Chair: Boehringer Ingelheim Study Coordinator, B.I. Pharma GmbH & Co. KG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2005

Primary Completion (Actual)

December 7, 2005

Study Completion (Actual)