Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00184977
Status:
COMPLETED
Last Update Posted:
2010-03-12
First Post:
2005-09-12
Brief Title:
COPD on Primary Care Treatment COOPT
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
A Double-blind Placebo-controlled Trial Comparing the Efficacy and Cost-effectiveness of Inhaled Fluticason Propionate Versus Oral N-acetylcysteine in the Treatment of Patients With COPD in General Practice
Status:
COMPLETED
Status Verified Date:
2006-08
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:
The aim of this family practice based study is to determine the long-term treatment effects of two drugs that are presumed to modify the course and progression of chronic obstructive pulmonary disease COPD oral N-acetylcysteine and inhaled corticosteroids
Detailed Description:
Chronic obstructive pulmonary disease COPD is a disorder characterised by symptoms and abnormal tests of expiratory flow that do not change markedly over periods of several months observation COPD includes chronic bronchitis and emphysema It is not fully clear which medication is the most efficacious in the long-term treatment of COPD In contrast to asthma the efficacy and therefore the precise role of inhaled corticosteroids is less clear in the treatment of patients with COPD The same applies to another much less investigated possibility in the treatment of COPD the anti-oxidant agent N-acetylcysteine N-acetylcysteine is used as a mucolytic agent in a variety of clinical conditions such as acute and chronic bronchitis and cystic fibrosis The aim of this study which is performed in family practices is to determine the 3-year treatment effects and cost-effectiveness of oral N-acetylcysteine versus an inhaled corticosteroid fluticason propionate in modifying the course and progression of COPD
Comparisons N-acetylcysteine oral 600 mg od and fluticason propionate dry powder inhalation 500 mcg bid are compared with placebo
Comparisons N-acetylcysteine oral 600 mg od and fluticason propionate dry powder inhalation 500 mcg bid are compared with placebo
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 95093 FLU9802 NAC-NL-11 | None | None | None |