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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00153075
First received: September 9, 2005
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Asthma
Device: Berodual Respimat
Device: Berodual HFA-MDI
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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).

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Whole lung deposition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Central lung zone deposition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Intermediate lung zone deposition [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Peripheral lung zone deposition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Ratio of peripheral to central zone deposition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Oropharyngeal deposition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Device deposition and exhaled air filter deposition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • FEV1 15, 30 and 60 minutes post-administration (safety only) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 19
Study Start Date: September 2005
Estimated Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00153075

Locations
Germany
Inamed Research GmbH & Co. KG
Gauting, Germany, 82131
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator B.I. Pharma GmbH & Co. KG
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00153075     History of Changes
Other Study ID Numbers: 215.1364
Study First Received: September 9, 2005
Last Updated: October 28, 2013
Health Authority: Germany: Ministry of Health

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 30, 2014