Dynamic Hyperinflation and Tiotropium

Gelb, Arthur F., M.D.

Status and phase: Completed; Phase 4

Conditions: COPD

Treatments: Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00569270

IIS Boehringer-Ingelheim (Other Grant/Funding Number)

20061693

IIS Pfizer (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Tiotropium 18 µg capsule, bronchodilator

Active Comparator group

Description:

tiotropium 18 µg capsule for 1 month versus placebo. To study bronchodilation and effect following metronome paced hyperventilation and induced dynamic hyperinflation of active tiotropium versus placebo

Treatment:

Drug: Placebo

2

Placebo Comparator group

Description:

placebo 18ug tiotropium for 1 month

Treatment:

Drug: Placebo