search
Back to results

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
Johannes Gutenberg University Mainz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, lung function, dysnpea

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with COPD of moderate to severe degree according to GOLD guidelines
  2. current or ex-smokers, no history of atopy, stable clinical condition, age of >40 years.

Exclusion Criteria:

  1. Significant lung disease other than COPD, unstable clinical condition
  2. 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

First Posted
November 20, 2007
Last Updated
November 20, 2007
Sponsor
Johannes Gutenberg University Mainz
Collaborators
AstraZeneca
search

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

Learn more about this trial

Change of Inspiratory Peak Flow in COPD

We'll reach out to this number within 24 hrs