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NCT Number: NCT00561886

Change of Inspiratory Peak Flow in COPD

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

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Johannes Gutenberg-Univeristy

Mainz, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Formoterol

Drug

One inhalation of 24µg Formoterol

Primary outcomes

  1. 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 outcomes

  1. Correlation of changes in FEV1, FIV1 and PIF following bronchodilation in spirometry

    Time frame: October 2007

  2. Correlation of change in PIF and symptomatic improvement in patients with COPD following bronchodilatation

    Time frame: October 2007

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

Change of Inspiratory Peak Flow After Bronchial Dilatation on Patients With Moderate to Severe COPD

Important dates

Study start
2007
Study completion
2007
First posted
Nov 21, 2007
Registry last updated
Nov 21, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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