Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00350207
Status:
COMPLETED
Last Update Posted:
2013-12-24
First Post:
2006-07-07
Brief Title:
Efficacy and Safety of Tiotropium and Salmeterol in Moderate Persistent Asthma Patients Homozygous for B16-ArgArg
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A 16-week Randomised Placebo-controlled Double-blind Double-dummy Parallel-group Study Comparing the Efficacy and Safety of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler 2 Actuations of 25 Mcg Once Daily With That of Salmeterol From the Hydrofluoroalkane Metered Dose Inhaler 2 Actuations of 25 Mcg Twice Daily in Moderate Persistent Asthma Patients With the B16-ArgArg Genotype
Status:
COMPLETED
Status Verified Date:
2013-09
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:
This is a 16 week multicentre multinational randomised double-blind double-dummy placebo-controlled parallel group study to evaluate the long-term efficacy and safety of tiotropium compared to salmeterol in moderate persistent asthmatic GINA step 3 patients homozygous for arginine at the 16th amino acid position of the beta-adrenergic receptor ADRB2 Following an initial 4-week run-in period on salmeterol MDI patients will be randomised into the 16 week double-blind treatment period in which they receive either tiotropium once daily administered from the Respimat inhaler or salmeterol twice daily administered from the hydrofluoro-alkane Metered Dose Inhaler MDI or placebo twice daily After the 16 week treatment period all patients will receive salmeterol MDI twice daily for four weeks
The patients perform daily morning and evening peak flow PEF and Forced Expiratory Volume in the First Second FEV1 measurements with an electronic peak flow meter throughout the study Daily data on asthma control and use of rescue medication are recorded using an electronic diary included in the electronic peak flow meter On study visits the Mini-Asthma Quality of Life Questionnaire Elizabeth Juniper is administered pulse and blood pressure and pre-dose pulmonary function testing FEV1 and Forced Vital Capacity are performed
The patients perform daily morning and evening peak flow PEF and Forced Expiratory Volume in the First Second FEV1 measurements with an electronic peak flow meter throughout the study Daily data on asthma control and use of rescue medication are recorded using an electronic diary included in the electronic peak flow meter On study visits the Mini-Asthma Quality of Life Questionnaire Elizabeth Juniper is administered pulse and blood pressure and pre-dose pulmonary function testing FEV1 and Forced Vital Capacity are performed
Detailed Description:
None
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