Change of Inspiratory Peak Flow in COPD
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Formoterol
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, lung function, dysnpea
Eligibility Criteria
Inclusion Criteria:
- Patients with COPD of moderate to severe degree according to GOLD guidelines
- current or ex-smokers, no history of atopy, stable clinical condition, age of >40 years.
Exclusion Criteria:
- Significant lung disease other than COPD, unstable clinical condition
- acute exacerbation in the last 2 month
Sites / Locations
- Johannes Gutenberg-Univeristy
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Patients with COPD receiving once 24 µg formoterol
Outcomes
Primary Outcome Measures
Change in inspiratory peak flow following administration of a bronchodilator assessed by inspiratory peak flow device in patients with moderate to sever COPD
Secondary Outcome Measures
Correlation of changes in FEV1, FIV1 and PIF following bronchodilation in spirometry
Correlation of change in PIF and symptomatic improvement in patients with COPD following bronchodilatation
Full Information
NCT ID
NCT00561886
First Posted
November 20, 2007
Last Updated
November 20, 2007
Sponsor
Johannes Gutenberg University Mainz
Collaborators
AstraZeneca
1. Study Identification
Unique Protocol Identification Number
NCT00561886
Brief Title
Change of Inspiratory Peak Flow in COPD
Official Title
Change of Inspiratory Peak Flow After Bronchial Dilatation on Patients With Moderate to Severe COPD
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Johannes Gutenberg University Mainz
Collaborators
AstraZeneca
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Chronic obstructive bronchitis and emphysema (COPD) are pathophysiologically characterized by inflammatory and structural changes in the lung. These changes lead to a reduction in elastic recoil as well as reduction in lung parenchyma. As a consequence collapse of the small airway occurs during expiration leading to expiratory flow limitation. In severe cases this flow limitation occurs even during resting condition. This expiratory collapse is suspected to mask changes in bronchial smooth muscle tone, especially if these changes in bronchial smooth muscle tone are assessed using expiratory manoeuvres. This might leave the impression of non-reversible airway obstruction und ineffectiveness of treatment with bronchodilators. Several studies suggest that in patients with COPD symptomatic changes following application of a bronchodilating compound do not correlate with changes in forced expiratory volumes. In contrast inspiratory lung function parameters (especially forced inspiratory volume in one second (FIV1)) is much more associated with symptomatic changes in patients with COPD. Comparable effects were also detected regarding peak inspiratory flow (PIF) values.Changes in inspiratory parameters following administration of a bronchodilator in patients with COPD and asthma are reproducible. PIF can easily be measured by inspiratory peak flow meters. So far no data exists on the usability of these devices following bronchodilation in patients with COPD. Formoterol is a rapid acting bronchodilator, which has been proven save in asthma and COPD
Detailed Description
N=40 patients with moderate to severe COPD (30 < FEV1 < 70 % pred.), no further significant lung disease; current smokers or ex-smokers; no exacerbation in the last 2 month.
Baseline visit Physical examination Dsypnea score (Borg-Scale, TDI) Lung function (Bodyplethysmography, CO-diffusion capacity)
Before each study day the following medication will be withheld:
Short-acting bronchodilators > 6 hours Long-acting b2-adrenoceptor agonist > 24 hours Tiotropium > 24 hours
Study day 1 Bodyplethysmography including FEV1, PEF, FIV1 and PIF and assessment of PIF using an inspiratory Peak Flow Meter in randomized order.
Dysnpea Scores 30 minute break Assessment of change in dyspnea (visual analogue scale) Bodyplethysmography including FEV1, PEF, FIV1 and PIF. Assessment of PIF using an inspiratory Peak Flow Meter in randomized order Administration of 12 µg formoterol 30 minute break Assessment of change in dyspnea (visual analogue scale) Bodyplethysmography including FEV1, PEF, FIV1 and PIF. Assessment of PIF using an inspiratory Peak Flow Meter in randomized order.
Study day 2 Three to 14 days following study day 1. Schedule like day 1 with change in the order of lung function testing depending on randomization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, lung function, dysnpea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Patients with COPD receiving once 24 µg formoterol
Intervention Type
Drug
Intervention Name(s)
Formoterol
Intervention Description
One inhalation of 24µg Formoterol
Primary Outcome Measure Information:
Title
Change in inspiratory peak flow following administration of a bronchodilator assessed by inspiratory peak flow device in patients with moderate to sever COPD
Time Frame
October 2007
Secondary Outcome Measure Information:
Title
Correlation of changes in FEV1, FIV1 and PIF following bronchodilation in spirometry
Time Frame
October 2007
Title
Correlation of change in PIF and symptomatic improvement in patients with COPD following bronchodilatation
Time Frame
October 2007
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with COPD of moderate to severe degree according to GOLD guidelines
current or ex-smokers, no history of atopy, stable clinical condition, age of >40 years.
Exclusion Criteria:
Significant lung disease other than COPD, unstable clinical condition
acute exacerbation in the last 2 month
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland Buhl, MD
Organizational Affiliation
Johannes Gutenberg University Mainz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johannes Gutenberg-Univeristy
City
Mainz
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
10903244
Citation
Taube C, Lehnigk B, Paasch K, Kirsten DK, Jorres RA, Magnussen H. Factor analysis of changes in dyspnea and lung function parameters after bronchodilation in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2000 Jul;162(1):216-20. doi: 10.1164/ajrccm.162.1.9909054.
Results Reference
background
PubMed Identifier
21145720
Citation
Taube C, Rydzy L, Eich A, Korn S, Kornmann O, Sebastian M, Jorres RA, Buhl R. Use of a portable device to record maximum inspiratory flow in relation to dyspnoea in patients with COPD. Respir Med. 2011 Feb;105(2):316-21. doi: 10.1016/j.rmed.2010.11.017. Epub 2010 Dec 9.
Results Reference
derived
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Change of Inspiratory Peak Flow in COPD
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