Ignite Creation Date:
2024-05-05 @ 9:34 PM
Last Modification Date:
2024-10-26 @ 10:06 AM
Study NCT ID:
NCT00911651
Status:
COMPLETED
Last Update Posted:
2009-06-02
First Post:
2009-05-28
Brief Title:
Study to Assess the Effect of Salbutamol and Ipratropium Bromide in Chronic Obstructive Pulmonary Disease COPD Patients
Sponsor:
University Hospital Antwerp
Organization:
University Hospital Antwerp
Study Overview
Official Title:
Open Randomized Two-Way Crossover Pilot Study to Assess the Effect of Salbutamol in Comparison With Ipratropium Bromide on Central and Peripheral Airway Dimensions in COPD Patients
Status:
COMPLETED
Status Verified Date:
2009-05
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 objectives of this study are to assess the effect of salbutamol in comparison with ipratropium bromide on the geometry of central and peripheral airways and to correlate spirometric indices with the Computational Fluid Dynamics CFD based calculated airway volumes and resistances for both compounds
Detailed Description:
Salbutamol VentolinTM is a short acting beta agonist SABA which is used to treat wheezing dyspnea and breathing difficulties caused by asthma and COPD Further it is also used to prevent bronchospasm during exercise
Ipratropium bromide Atrovent HFA is a short acting anticholinergic bronchodilator short acting muscarinic antagonist SAMA that improves lung function dyspnea exercise tolerance and health-related quality of life in patients with COPD Studies have also shown that ipratropium bromide might reduce COPD exacerbations and related hospitalisations because the extended bronchodilatation might reduce infection rates by improving clearance of respiratory secretions
In this open randomized two-way crossover pilot study the effect of salbutamol in patients with moderate and severe COPD will be examined in comparison with the effects of ipratropium bromide These patients will receive 400 µg salbutamol and 80 µg ipratropium bromide in a randomized crossover design
The objectives of this study are to assess the effect of salbutamol in comparison with ipratropium bromide on the geometry of central and peripheral airways and to correlate spirometric indices as Forced Expiratory Volume in one second FEV1 and Tiffeneau index with the Computational Fluid Dynamics CFD based calculated airway volumes and resistances for both compounds
Ipratropium bromide Atrovent HFA is a short acting anticholinergic bronchodilator short acting muscarinic antagonist SAMA that improves lung function dyspnea exercise tolerance and health-related quality of life in patients with COPD Studies have also shown that ipratropium bromide might reduce COPD exacerbations and related hospitalisations because the extended bronchodilatation might reduce infection rates by improving clearance of respiratory secretions
In this open randomized two-way crossover pilot study the effect of salbutamol in patients with moderate and severe COPD will be examined in comparison with the effects of ipratropium bromide These patients will receive 400 µg salbutamol and 80 µg ipratropium bromide in a randomized crossover design
The objectives of this study are to assess the effect of salbutamol in comparison with ipratropium bromide on the geometry of central and peripheral airways and to correlate spirometric indices as Forced Expiratory Volume in one second FEV1 and Tiffeneau index with the Computational Fluid Dynamics CFD based calculated airway volumes and resistances for both compounds
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