Evaluation of the Respimat Inhaler vs. a HFA MDI Using Berodual in Patients With COPD With Poor MDI Technique.

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00267917
First received: December 21, 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 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.


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, 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.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • The primary endpoint is the percentage of lung deposition achieved with natural inhaler technique compared with supervised optimal administration. [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Central lung zone deposition [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Intermediate lung zone deposition [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Peripheral lung zone deposition [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Ratio of peripheral lung zone to central lung zone deposition [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Oropharyngeal deposition [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • FEV1 15, 30 and 60 minutes post-administration (safety only) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 13
Study Start Date: January 2006
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Detailed Description:

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.

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 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.

Comparison(s):

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.

  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 s creening 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: NCT00267917

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: NCT00267917     History of Changes
Other Study ID Numbers: 215.1365
Study First Received: December 21, 2005
Last Updated: October 28, 2013
Health Authority: Germany: Bundesamt fuer Strahlenschutz

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 23, 2014