Tiotropium Induced Bronchodilation in Lung CT Scored Emphysema

August 13, 2008 updated by: Gelb, Arthur F., M.D.

Effectiveness of Tiotropium to Maintain Inspiratory Capacity Against Metronome Paced Hyperventilation Induced Dynamic Hyperinflation in COPD Patients With 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

29

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Lakewood, California, United States, 90712
        • Arthur F Gelb Medical Corporation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with moderate to severe copd from tertiary care pulmonary clinic

Description

Inclusion Criteria

  • moderate to severe copd

Exclusion Criteria

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
patients with moderate to severe copd with varying extent of emphysema
Drug: tiotropium
18ug capsule daily for 30 days
Other Names:
  • Spiriva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
After 30 days and 1.5hr of tiotropium

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlate decrease in IC and FEV 1 following dynamic hyperinflation with underlying emphysema.
Time Frame: After 30 days and 1.5hr of tiotropium
After 30 days and 1.5hr of tiotropium

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gelb, Arthur F., M.D.

Collaborators

Pfizer
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

December 10, 2007

First Submitted That Met QC Criteria

December 10, 2007

First Posted (Estimate)

December 11, 2007

Study Record Updates

Last Update Posted (Estimate)

August 14, 2008

Last Update Submitted That Met QC Criteria

August 13, 2008

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000
  • Pfizer (Pfizer)
  • Boehringer-Ingelheim Pharm.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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