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Completed

NCT Number: NCT00570544

Tiotropium Induced Bronchodilation in Lung CT Scored Emphysema

To evaluate if tiotropium (Spiriva)induced bronchodilation of inspiratory capacity in patients with moderate to severe copd subjected to metronome paced hyperventilation induced dynamic hyperinflation is dependent upon the extent of underlying emphysema as determined by high resolution-thin section CT lung.

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Key information

Conditions

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

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Arthur F Gelb Medical Corporation

Lakewood, California, 90712, United States

About this study

We will analyze post hoc, data that was previously published: Gelb AF et al.Chest 2006;131:690-695. We have shown that tiotropium increases resting inspiratory capacity thereby providing lung volume protection against metronome paced hyperventilation induced dynamic hyperinflation. End point will be to correlate increase in tiotropium induced FEV 1(L) and inspiratory capacity with extent of underlying emphysema as scored by lung CT ( Gelb AF et al:Chest 1996; 109: 353-359)in 29 patients with COPD. We will also correlate the decrease in inspiratory capacity following metronome paced hyperventilation induced dynamic hyperinflation with extent of lung CT scored emphysema.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • moderate to severe copd

Exclusion criteria

  • unable to tolerate tiotropium
  • unable to perform metronome paced hyperventilation induced dynamic hyperinflation

Treatment and study plan

Tiotropium

Drug

18ug capsule daily for 30 days

Other names: Spiriva

Primary outcomes

  1. Correlate tiotropium induced increase in inspiratory capacity (IC)and FEV 1 with extent of emphysema as scored by lung CT.

    Time frame: After 30 days and 1.5hr of tiotropium

Secondary outcomes

  1. Correlate decrease in IC and FEV 1 following dynamic hyperinflation with underlying emphysema.

    Time frame: After 30 days and 1.5hr of tiotropium

Sponsors and collaborators

Lead sponsor

Gelb, Arthur F., M.D.

Indiv

Collaborators

  • Boehringer Ingelheim
  • Pfizer

Registry information

Official study title

Effectiveness of Tiotropium to Maintain Inspiratory Capacity Against Metronome Paced Hyperventilation Induced Dynamic Hyperinflation in COPD Patients With Lung CT Scored Emphysema

Important dates

Study start
2004
Study completion
2005
First posted
Dec 11, 2007
Registry last updated
Aug 14, 2008

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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