Clinical trial NCT00569270: Dynamic Hyperinflation and Tiotropium
Official title: Simplified Detection of Dynamic Hyperinflation Using Metronome Paced Hyperventilation and the Effect of Tiotropium in Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COPD
Lead sponsor: Gelb, Arthur F., M.D.
Sponsor class: INDIV
Collaborators: name: Boehringer Ingelheim
name: Pfizer
First posted: 2007-12-07
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: We will detect dynamic hyperinflation (DH) in 40 COPD (chronic obstructive pulmonary disease) patients with moderately severe disease using metronome paced hyperventilation (MPH) with inspiratory capacity as the primary end point. Hypothesis: Is tiotropium capable of lung volume protecting inspiratory capacity from MPH induced DH vs placebo in a randomized crossover double blinded study.

Detailed description: Study completed with 29 patients studied. Data is being analyzed to evaluate trough and peak effect of 18 µg tiotropium vs placebo on FEV 1 (L)(forced expiratory capacity in one second), inspiratory capacity and functional residual volume. In addition, we will study the effect of 18 µg tiotropium vs placebo on metronome paced hyperventilation induced dynamic hyperinflation. We will also evaluate the effect of tiotropium induced increase in IC (inspiratory capacity) vs extent of emphysema as evaluated on high resolution thin section CT lung

Eligibility criteria: Inclusion Criteria:

* Moderately severe COPD patients age 40-85 yr with post 180ug albuterol FEV 1 between 60 and 79% predicted and FEV 1/FVC \< 70%.
* Smoking history \> 10 pack yr.
* Clinically stable X 6 weeks.
* No oxygen usage.

Exclusion Criteria:

* History of asthma
* Clinically unstable
* Any other significant medical problem precluding full cooperation for study

Primary outcomes:
measure: Bronchodilator Response:Peak FEV1(L)(Forced Expiratory Volume in One Second)-
timeFrame: 30 days
measure: Bronchodilator Response:Peak FRC (L) (Functional Residual Capacity)
timeFrame: 30 days
measure: Bronchodilator Response: Peak FVC (L) (Forced Vital Capacity)- Tiotropium and Placebo
timeFrame: 30 days
measure: Bronchodilator Response: Peak IC (L) - (Inspiratory Capacity) - Tiotropium Versus Placebo
timeFrame: 30 days
measure: Bronchodilator Response: Peak FRC/TLC Percentage (Functional Residual Capacity(L)/Total Lung Capacity(L) - Tiotropium or Placebo
timeFrame: 30 days
measure: Bronchodilator Response: Peak TLC (L) (Total Lung Capacity)- Tiotropium or Placebo
timeFrame: 30 days
measure: Bronchodilator Response: Trough FEV1 (L)- (Forced Expiratory Volume) Tiotropium Versus Placebo
timeFrame: 30 days
measure: Bronchodilator Response: Trough FRC (L)- Tiotropium Versus Placebo
timeFrame: 30 days
measure: Bronchodilator Response: Trough FVC (L)- (Forced Vital Capacity) Tiotropium Versus Placebo
timeFrame: 30 days
measure: Bronchodilator Response: Trough IC (L) Inspiratory Capacity - Tiotropium Versus Placebo
timeFrame: 30 days
measure: Bronchodilator Response: Trough FRC/TLC (Functional Residual Capacity/Total Lung Capacity)- Tiotropium Versus Placebo
timeFrame: 30 days
measure: Bronchodilator Response: Trough TLC (L) (Total Lung Capacity)- Tiotropium Versus Placebo
timeFrame: 30 days
measure: IC (Inspiratory Capacity L)and Metronome Paced Hyperventilation-induced Dynamic Hyperinflation in Tiotropium Cohort Versus Placebo and Baseline
timeFrame: baseline and 30 days (+2h) post dose
measure: TLC (L) Before and After Metronome Paced Hyperventilation Induced Dynamic Hyperinflation in Tiotropium Cohort Versus Placebo
timeFrame: one hour before intervention & 2 hrs. after after 30 days
Secondary outcomes:
measure: Extent of Lung CT Scored Emphysema and and Lung Function of FEV1(l) After Tiotropium
timeFrame: baseline to 30 days
measure: IC (Inspiratory Capacity, L) Post Mph (Metronome Paced Hyperventilation) Induced dh (Dynamic Hyperinflation) After Tiotropium and Extent of Lung CT Scored Emphysema
timeFrame: baseline to 30 days
measure: Extent of Lung CT Scored Emphysema and and Lung Function of FRC/TLC (Functional Residual Capacity(L)/Total Lung Capacity (L) After Tiotropium
timeFrame: baseline to trough tiotropium
Other outcomes:
Locations:
city: Lakewood
country: United States
facility: Arthur F Gelb MD
state: California
city: Toronto
country: Canada
facility: Noe Zamel MD
state: Ontario
Study officials:
affiliation: Arthur F Gelb Medical Corporation
name: Arthur F Gelb, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mt. Sinai Hosp. Toronto, Univ Toronto Medical Center
name: Noe Zamel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gelb AF, Gutierrez CA, Weisman IM, Newsom R, Taylor CF, Zamel N. Simplified detection of dynamic hyperinflation. Chest. 2004 Dec;126(6):1855-60. doi: 10.1378/chest.126.6.1855.
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, Fraser C, Zamel N. Lack of protective effect of tiotropium vs induced dynamic hyperinflation in moderate COPD. Respir Med. 2011 May;105(5):755-60. doi: 10.1016/j.rmed.2010.11.020. Epub 2010 Dec 14.