Tiotropium Induced Bronchodilation in Lung CT Scored Emphysema

NCT00570544 | Completed DMC

• 3 other identifiers: 1000Boehringer-Ingelheim Pharm.Pfizer
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Emphysema

Keywords

copd; emphysema; tiotropium; lung function; dynamic hyperinflation

Outcome Measures

Primary Outcomes (1)

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

  After 30 days and 1.5hr of tiotropium

Secondary Outcomes (1)

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

  After 30 days and 1.5hr of tiotropium

Study Arms (1)

1

patients with moderate to severe copd with varying extent of emphysema

Drug: tiotropium

Interventions

tiotropium DRUG

18ug capsule daily for 30 days

Also known as: Spiriva

1

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with moderate to severe copd from tertiary care pulmonary clinic

You may qualify if:

• moderate to severe copd

You may not qualify if:

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

Sponsors & Collaborators

• Gelb, Arthur F., M.D.: lead
• Boehringer Ingelheim: collaborator
• Pfizer: collaborator

Study Sites (1)

Arthur F Gelb Medical Corporation

Lakewood, California, 90712, United States

Location

Related Publications (2)

• 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.

  PMID: 17356081 BACKGROUND

• 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.

  PMID: 8620705 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Arthur F Gelb, MD

  Arthur F Gelb Medical Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: December 10, 2007
• First Posted: December 11, 2007
• Study Start: August 1, 2004
• Study Completion: August 1, 2005
• Last Updated: August 14, 2008

Record last verified: 2007-12

Locations

US (1)