Tiotropium Induced Bronchodilation in Lung CT Scored Emphysema - Full Text View

Sponsors and Collaborators:	Gelb, Arthur F., M.D. Boehringer Ingelheim Pharmaceuticals Pfizer
Information provided by:	Gelb, Arthur F., M.D.
ClinicalTrials.gov Identifier:	NCT00570544

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 IV

MedlinePlus related topics: Emphysema

Drug Information available for: Tiotropium Tiotropium bromide Benzocaine

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Crossover, 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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

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:

Gelb AF, Taylor CF, McClean PA, Shinar CM, Rodrigues MT, Gutierrez CA, Chapman KR, Zamel N. Tiotropium and simplified detection of dynamic hyperinflation. Chest. 2007 Mar;131(3):690-5.

Gelb AF, Hogg JC, Müller NL, Schein MJ, Kuei J, Tashkin DP, Epstein JD, Kollin J, Green RH, Zamel N, Elliott WM, Hadjiaghai L. Contribution of emphysema and small airways in COPD. Chest. 1996 Feb;109(2):353-9.

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

Keywords provided by Gelb, Arthur F., M.D.:

copd
emphysema
tiotropium
lung function
dynamic hyperinflation

Study placed in the following topic categories:

Pulmonary Emphysema
Emphysema
Lung Diseases, Obstructive
Respiratory Tract Diseases

Lung Diseases
Benzocaine
Tiotropium
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Parasympatholytics
Respiratory System Agents
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents

Cholinergic Agents
Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 13, 2009