Evaluation of the Respimat Inhaler vs. a HFA MDI Using Berodual in Patients With COPD With Poor MDI Technique.
Primary Purpose
Pulmonary Disease, Chronic Obstructive, Asthma
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Berodual Respimat
Berodual HFA-MDI
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
Eligibility 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
Sites / Locations
- Inamed Research GmbH & Co. KG
Outcomes
Primary Outcome Measures
The primary endpoint is the percentage of lung deposition achieved with natural inhaler technique compared with supervised optimal administration.
Secondary Outcome Measures
Central lung zone deposition
Intermediate lung zone deposition
Peripheral lung zone deposition
Ratio of peripheral lung zone to central lung zone deposition
Oropharyngeal deposition
FEV1 15, 30 and 60 minutes post-administration (safety only)
Full Information
NCT ID
NCT00267917
First Posted
December 21, 2005
Last Updated
December 27, 2017
Sponsor
Boehringer Ingelheim
1. Study Identification
Unique Protocol Identification Number
NCT00267917
Brief Title
Evaluation of the Respimat Inhaler vs. a HFA MDI Using Berodual in Patients With COPD With Poor MDI Technique.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
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 inhal er 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive, Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Berodual Respimat
Intervention Type
Device
Intervention Name(s)
Berodual HFA-MDI
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Central lung zone deposition
Time Frame
8 weeks
Title
Intermediate lung zone deposition
Time Frame
8 weeks
Title
Peripheral lung zone deposition
Time Frame
8 weeks
Title
Ratio of peripheral lung zone to central lung zone deposition
Time Frame
8 weeks
Title
Oropharyngeal deposition
Time Frame
8 weeks
Title
FEV1 15, 30 and 60 minutes post-administration (safety only)
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
B.I. Pharma GmbH & Co. KG
Official's Role
Study Chair
Facility Information:
Facility Name
Inamed Research GmbH & Co. KG
City
Gauting
ZIP/Postal Code
82131
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/215/215.1365_U06-2082.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/215/215.1365_literature.pdf
Description
Related Info
URL
https://www.ncbi.nlm.nih.gov/pubmed/19281091
Description
Related Info
Learn more about this trial
Evaluation of the Respimat Inhaler vs. a HFA MDI Using Berodual in Patients With COPD With Poor MDI Technique.
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