Change of Inspiratory Peak Flow in COPD

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT00561886
First received: November 20, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

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


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Formoterol
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Change of Inspiratory Peak Flow After Bronchial Dilatation on Patients With Moderate to Severe COPD

Resource links provided by NLM:


Further study details as provided by Johannes Gutenberg University Mainz:

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 [ Time Frame: October 2007 ]

Secondary Outcome Measures:
  • Correlation of changes in FEV1, FIV1 and PIF following bronchodilation in spirometry [ Time Frame: October 2007 ]
  • Correlation of change in PIF and symptomatic improvement in patients with COPD following bronchodilatation [ Time Frame: October 2007 ]

Enrollment: 40
Study Start Date: April 2007
Study Completion Date: October 2007
Arms Assigned Interventions
Experimental: 1
Patients with COPD receiving once 24 µg formoterol
Drug: Formoterol
One inhalation of 24µg Formoterol

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561886

Locations
Germany
Johannes Gutenberg-Univeristy
Mainz, Germany
Sponsors and Collaborators
Johannes Gutenberg University Mainz
AstraZeneca
Investigators
Principal Investigator: Roland Buhl, MD Johannes Gutenberg University Mainz
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00561886     History of Changes
Other Study ID Numbers: IPF0601T, IPF0601T
Study First Received: November 20, 2007
Last Updated: November 20, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johannes Gutenberg University Mainz:
COPD
lung function
dysnpea

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Formoterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014