Clinical trial NCT00570544: Tiotropium Induced Bronchodilation in Lung CT Scored Emphysema
Official title: Effectiveness of Tiotropium to Maintain Inspiratory Capacity Against Metronome Paced Hyperventilation Induced Dynamic Hyperinflation in COPD Patients With Lung CT Scored Emphysema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Emphysema
Keywords: copd
emphysema
tiotropium
lung function
dynamic hyperinflation
Lead sponsor: Gelb, Arthur F., M.D.
Sponsor class: INDIV
Collaborators: name: Boehringer Ingelheim
name: Pfizer
First posted: 2007-12-11
Enrollment: 29
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with moderate to severe copd from tertiary care pulmonary clinic

Brief summary: 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.

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 criteria: Inclusion Criteria

* moderate to severe copd

Exclusion Criteria

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

Primary outcomes:
measure: Correlate tiotropium induced increase in inspiratory capacity (IC)and FEV 1 with extent of emphysema as scored by lung CT.
timeFrame: After 30 days and 1.5hr of tiotropium
Secondary outcomes:
measure: Correlate decrease in IC and FEV 1 following dynamic hyperinflation with underlying emphysema.
timeFrame: After 30 days and 1.5hr of tiotropium
Other outcomes:
Locations:
city: Lakewood
country: United States
facility: Arthur F Gelb Medical Corporation
state: California
Study officials:
affiliation: Arthur F Gelb Medical Corporation
name: Arthur F Gelb, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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):690-695. doi: 10.1378/chest.06-1662.
citation: Gelb AF, Hogg JC, Muller 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. doi: 10.1378/chest.109.2.353.