Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00274040
Status:
COMPLETED
Last Update Posted:
2013-11-01
First Post:
2006-01-09
Brief Title:
Comparison of Tiotropium and Ipratropium in a Double-Blind Double-dummy Efficacy and Safety Study in Adults With COPD
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 qid in patients 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 qid in patients with chronic obstructive pulmonary disease COPD
Detailed Description:
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 0800 am and 1000 am
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 0800 am and 1000 am 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
Comparisons
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
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 0800 am and 1000 am
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 0800 am and 1000 am 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
Comparisons
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None