Change of Inspiratory Peak Flow in COPD

NCT ID: NCT00561886

Last Updated: 2007-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2007-10-31

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; lung function; dysnpea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Patients with COPD receiving once 24 µg formoterol

Group Type: EXPERIMENTAL

Formoterol

Intervention Type: DRUG

One inhalation of 24µg Formoterol

Interventions

Formoterol

One inhalation of 24µg Formoterol

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Johannes Gutenberg University Mainz

OTHER

Sponsor Role: lead

Principal Investigators

Roland Buhl, MD

Role: PRINCIPAL_INVESTIGATOR

Johannes Gutenberg University Mainz

Locations

Johannes Gutenberg-Univeristy

Mainz, , Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 10903244 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21145720 (View on PubMed)

Other Identifiers

IPF0601T

Identifier Type: -

Identifier Source: secondary_id

IPF0601T

Identifier Type: -

Identifier Source: org_study_id