Phase 4 N=30 Randomized Quadruple-blind Treatment

Dynamic Hyperinflation and Tiotropium

COPD

Bottom Line

View on ClinicalTrials.gov: NCT00569270 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2012

Primary outcome: Primary: Bronchodilator Response:Peak FEV1(L)(Forced Expiratory Volume in One Second)- — 1.74; 1.82 liters — p=0.027

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Placebo (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Gelb, Arthur F., M.D.
Primary completion: Feb 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Bronchodilator Response:Peak FEV1(L)(Forced Expiratory Volume in One Second)-	1.74; 1.82	0.027 sig
PRIMARY Bronchodilator Response:Peak FRC (L) (Functional Residual Capacity)	3.80; 3.72	0.318
PRIMARY Bronchodilator Response: Peak FVC (L) (Forced Vital Capacity)- Tiotropium and Placebo	3.17; 3.27	0.078
PRIMARY Bronchodilator Response: Peak IC (L) - (Inspiratory Capacity) - Tiotropium Versus Placebo	2.12; 2.24	0.067
PRIMARY Bronchodilator Response: Peak FRC/TLC Percentage (Functional Residual Capacity(L)/Total Lung Capacity(L) - Tiotropium or Placebo	0.65; 0.66	0.615
PRIMARY Bronchodilator Response: Peak TLC (L) (Total Lung Capacity)- Tiotropium or Placebo	5.91; 5.82	0.325
PRIMARY Bronchodilator Response: Trough FEV1 (L)- (Forced Expiratory Volume) Tiotropium Versus Placebo	1.68; 1.71	0.345
PRIMARY Bronchodilator Response: Trough FRC (L)- Tiotropium Versus Placebo	3.84; 3.66	0.068
PRIMARY Bronchodilator Response: Trough FVC (L)- (Forced Vital Capacity) Tiotropium Versus Placebo	3.12; 3.15	0.589
PRIMARY Bronchodilator Response: Trough IC (L) Inspiratory Capacity - Tiotropium Versus Placebo	2.17; 2.11	0.922
PRIMARY Bronchodilator Response: Trough FRC/TLC (Functional Residual Capacity/Total Lung Capacity)- Tiotropium Versus Placebo	0.64; 0.62	-0.02 sig
PRIMARY Bronchodilator Response: Trough TLC (L) (Total Lung Capacity)- Tiotropium Versus Placebo	5.99; 5.86	-0.13
PRIMARY IC (Inspiratory Capacity L)and Metronome Paced Hyperventilation-induced Dynamic Hyperinflation in Tiotropium Cohort Versus Placebo and Baseline	2.09; 1.76; 2.17; 1.80; 2.24; 1.80	0.0001 sig
PRIMARY TLC (L) Before and After Metronome Paced Hyperventilation Induced Dynamic Hyperinflation in Tiotropium Cohort Versus Placebo	5.96; 5.84; 5.84; 5.78	>0.05
SECONDARY Extent of Lung CT Scored Emphysema and and Lung Function of FEV1(l) After Tiotropium	13.68	0.96
SECONDARY IC (Inspiratory Capacity, L) Post Mph (Metronome Paced Hyperventilation) Induced dh (Dynamic Hyperinflation) After Tiotropium and Extent of Lung CT Scored Emphysema	13.68	0.4
SECONDARY Extent of Lung CT Scored Emphysema and and Lung Function of FRC/TLC (Functional Residual Capacity(L)/Total Lung Capacity (L) After Tiotropium	13.68	0.36

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.

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 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

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Data sourced from ClinicalTrials.gov (NCT00569270). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.