Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Comparison of 18 μg of Tiotropium Inhalation Capsules and Atrovent Metered Dose Inhaler (2 Puffs of 20 μg, 4 Times Daily) in a Double-Blind, Double-Dummy, Efficacy and Safety Study in Adults With Chronic Obstructive Pulmonary Disease (COPD).
Comparison of 18 mcg of Tiotropium Inhalation Capsules and ipratropiumMetered Dose Inhaler
(2 puffs of 20 mcg, four times daily) in a Double-Blind, Double-dummy, Efficacy and Safety
Study in Adults with Chronic Obstructive Pulmonary Disease (COPD).
The objective of this study is to compare the bronchodilator efficacy and safety of
tiotropium inhalation capsules (18 mcg once daily) and ipratropium MDI (2 puffs of 20 mcg
q.i.d.) in patients with chronic obstructive pulmonary disease (COPD).
This is a 2-treatment, randomized, double-blind, parallel design trial in adult patient with
COPD.
Each dose of tiotropium or placebo will consist of one capsule self administered from the
HandiHaler device once daily during the treatment period (tiotropium or placebo). Each dose
will be taken at the same time each morning between 08:00 a.m. and 10:00 a.m.
Each dose of ipratropium MDI or placebo MDI will consist of 2 puffs; patients will inhale 2
puffs four times daily. The first dose will be taken at the same time each morning between
08:00 a.m. and 10:00 a.m.; subsequent doses will be taken at lunch, at dinner and when going
to bed.
Study Hypothesis:
The null hypothesis is that there is no difference in mean response between tiotropium and
ipratropium.
The alternative hypothesis is that there is a difference in mean response between tiotropium
and ipratropium.
Comparison(s):
This is a multi-center, randomized, double-blind, double-dummy, parallel group trial to
compare the bronchodilator efficacy and safety of Tiotropium (18 mcg once a day) and
ipratropium Metered Dose Inhaler (2 puffs of 18 mcg four times a day).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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