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Tiotropium Induced Bronchodilation in Lung CT Scored Emphysema

This study has been completed.
Sponsor:
Collaborators:
Boehringer Ingelheim Pharmaceuticals
Pfizer
Information provided by:
Gelb, Arthur F., M.D.
ClinicalTrials.gov Identifier:
NCT00570544
First received: December 10, 2007
Last updated: August 13, 2008
Last verified: December 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
COPD
Emphysema
 Drug: tiotropium
 Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Retrospective
Official Title: Effectiveness of Tiotropium to Maintain Inspiratory Capacity Against Metronome Paced Hyperventilation Induced Dynamic Hyperinflation in COPD Patients With Lung CT Scored Emphysema

Resource links provided by NLM:

MedlinePlus related topics: Emphysema
U.S. FDA Resources

Further study details as provided by Gelb, Arthur F., M.D.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlate decrease in IC and FEV 1 following dynamic hyperinflation with underlying emphysema. [ Time Frame: After 30 days and 1.5hr of tiotropium ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: August 2004
Study Completion Date: August 2005
Groups/Cohorts Assigned Interventions
1
patients with moderate to severe copd with varying extent of emphysema
 Drug: tiotropium
18ug capsule daily for 30 days
Other Name: Spiriva

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.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with moderate to severe copd from tertiary care pulmonary clinic

Criteria

Inclusion Criteria

  • moderate to severe copd

Exclusion Criteria

  • unable to tolerate tiotropium
  • unable to perform metronome paced hyperventilation induced dynamic hyperinflation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00570544

Locations
United States, California
Arthur F Gelb Medical Corporation
Lakewood, California, United States, 90712
Sponsors and Collaborators
Gelb, Arthur F., M.D.
Boehringer Ingelheim Pharmaceuticals
Pfizer
Investigators
Principal Investigator: Arthur F Gelb, MD Arthur F Gelb Medical Corporation
  More Information

Publications:

Responsible Party: Arthur F Gelb MD, Arthur F Gelb Medical Corporation
ClinicalTrials.gov Identifier: NCT00570544     History of Changes
Other Study ID Numbers: 1000, Boehringer-Ingelheim Pharm., Pfizer
Study First Received: December 10, 2007
Last Updated: August 13, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Gelb, Arthur F., M.D.:
copd
emphysema
tiotropium
lung function
dynamic hyperinflation

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pulmonary Disease, Chronic Obstructive
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Tiotropium
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013