Study to Assess the Effect of Salbutamol and Ipratropium Bromide in Chronic Obstructive Pulmonary Disease (COPD) Patients
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|ClinicalTrials.gov Identifier: NCT00911651|
Recruitment Status : Completed
First Posted : June 2, 2009
Last Update Posted : June 2, 2009
|Condition or disease||Intervention/treatment||Phase|
|COPD||Drug: Salbutamol Drug: ipratropium bromide||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||August 2008|
Active Comparator: salbutamol
6 patients with moderate (GOLD 2) and severe (GOLD 3) COPD
400 µg inhalation once
Other Name: Ventolin
Active Comparator: ipratropium bromide
COPD patients GOLD stage II and III
Drug: ipratropium bromide
80 µg inhalation once
Other Name: atrovent
- The primary objective of this study is to assess the effect of a single dose of salbutamol in comparison with ipratropium bromide on central and peripheral small airways with high-resolution/multislice CT scan imaging technique. [ Time Frame: 1 month ]
- The secondary objectives are to evaluate effects on spirometric indices to correlate these with the CFD based calculated airway volumes and resistances for both compounds and to evaluate the safety of the products. [ Time Frame: 1 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00911651
|Antwerp University Hospital|
|Antwerp, Belgium, 2650|
|Principal Investigator:||Wilfried A De Backer, MD PhD||University Hospital, Antwerp|