Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00274066
Status:
COMPLETED
Last Update Posted:
2013-11-01
First Post:
2006-01-09
Brief Title:
Acute Bronchodilator Response of a Single Dose of Atrovent or Berotec on Top of Pharmacodynamic Steady State of Spiriva
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
The Acute Bronchodilator Effects of a Single Dose 2 Puffs of the Shortacting Anticholinergic Ipratropium Bromide 40μg and the Short-acting Beta-adrenergic Fenoterol 200μg in Comparison to Placebo on Top of Pharmacodynamic Steady State of Once Daily Tiotropium 18μg Inhalation Capsule in Patients With Chronic 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:
To evaluate acute effect of single dose of ipratropium Atrovent or fenoterol Berotec in comparison to placebo when given to COPD patients on pharmacodynamic steady state of tiotropium Spiriva
Detailed Description:
In case mono-bronchodilator therapy does not control symptoms of COPD adequately or if regular maintenance therapy is desired a therapeutic intervention with a combination of bronchodilators is recommended The risks of side-effects increases with increasing dose of any drug and therefore the most important rationale for combination therapy is a very favourable ratio of efficacy and safety Knowing that anticholinergic and beta-adrenergic agents achieve their bronchodilating effects by different mechanisms in particular the combination of these agents has proven to be beneficial in the management of COPD Based on the established clinical benefits tiotropium is an attractive and promising agent for the first-line long-term maintenance therapy in COPD This also implies that a therapeutic intervention with other bronchodilators will be prescribed in daily practice At present no studies on combination therapy with short-acting agents are available Therefore using a double-blind randomised crossover design the bronchodilator effects of single doses of ipratropium or fenoterol were compared with placebo when added on top of steady state tiotropium Patients were pre-treated with tiotropium to achieve this pharmacodynamic steady state Serial lung function tests FEV1 FVC Raw sGaw were conducted following add-on of the short-acting bronchodilators or placebo
Study Hypothesis
H0 there is no difference between treatments in mean peak FEV1 H1 there is a difference between treatments in mean peak FEV1
Comparisons
Add-on of placebo was compared to add-on of ipratropium or add-on of fenoterol The comparison of ipratropium with placebo was primary The other 2 pair-wise comparisons were secondary
Study Hypothesis
H0 there is no difference between treatments in mean peak FEV1 H1 there is a difference between treatments in mean peak FEV1
Comparisons
Add-on of placebo was compared to add-on of ipratropium or add-on of fenoterol The comparison of ipratropium with placebo was primary The other 2 pair-wise comparisons were secondary
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