Change of Inspiratory Peak Flow in COPD

NCT00561886 | Completed Phase 4 DMC

• 1 other identifier: IPF0601T
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; lung function; dysnpea

Outcome Measures

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

  October 2007

Secondary Outcomes (2)

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

  October 2007

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

  October 2007

Study Arms (1)

1

EXPERIMENTAL

Patients with COPD receiving once 24 µg formoterol

Drug: Formoterol

Interventions

Formoterol DRUG

One inhalation of 24µg Formoterol

1

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Significant lung disease other than COPD, unstable clinical condition
• acute exacerbation in the last 2 month

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead
• AstraZeneca: collaborator

Study Sites (1)

Johannes Gutenberg-Univeristy

Mainz, Germany

Location

Related Publications (2)

• 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.

  PMID: 10903244 BACKGROUND

• 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.

  PMID: 21145720 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Formoterol Fumarate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Roland Buhl, MD

  Johannes Gutenberg University Mainz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 20, 2007
• First Posted: November 21, 2007
• Study Start: April 1, 2007
• Study Completion: October 1, 2007
• Last Updated: November 21, 2007

Record last verified: 2007-11

Locations

DE (1)