NCT00911651

Study to Assess the Effect of Salbutamol and Ipratropium Bromide in Chronic Obstructive Pulmonary Disease (COPD) Patients

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University Hospital, Antwerp · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COPD

Interventions

Type	Name	Description
DRUG	Salbutamol	400 µg inhalation once
DRUG	ipratropium bromide	80 µg inhalation once

Timeline

• Start date: 2008-06-01
• Primary completion: 2008-07-01
• Completion: 2008-08-01
• First posted: 2009-06-02
• Last updated: 2009-06-02

Locations

1 site across 1 country: Belgium