OPEN-LABEL, PROSPECTIVE EXPLORATORY STUDY TO ASSESS THE EFFECTS OF FORMOTEROL AND BECLOMETASONE DIPROPIONATE COMBINATION THERAPY USING A DPI DEVICE ON CENTRAL AND PERIPHERAL AIRWAY DIMENSIONS IN ASTHMATIC PATIENTS.

NCT01650441 Phase 2 COMPLETED

The objective of this study is to evaluate the effect of the combination of formoterol and beclometasone dipropionate in a dry powder inhaler (NEXThaler®) on central and peripheral airway dimensions in asthmatic patients. Therefore Computational Fluid Dynamics (CFD) will be used. Further more, the effect of this combination therapy on lung function (spirometry, resistance and diffusion), the Asthma Control Test (ACT™) and the Asthma Control Questionnaire (ACQ) will be assessed and the safety will be evaluated.

Details

Lead sponsor	University Hospital, Antwerp
Phase	Phase 2
Status	COMPLETED
Enrolment	31
Start date	2012-04
Completion	2013-06

Conditions

• Asthma

Interventions

• Beclomethasone dipropionate 100 µg + formoterol fumarate 6 µg
• CT thorax

Primary outcomes

• Computational Fluid Dynamics (CFD) — CFD will be performed based on the images of 2 CT thorax scans in a dose reduction protocol (1 CT Thorax taken at baseline and 1 CT Thorax taken after 6 months of treatment with the NEXThaler® device).
  The parameters that will be obtained with the CFD based imaging and used as primary outcome parameters are: * Total airway resistance for the segmented airways iRtot * Peripheral airway resistance(from 4th bifurcation on) for the segmented airways iRperph * Total airway volume for the segmented airways (iVtot) * Peripheral airway volume (from the 4th bifurcation on) for the segmented airways (iVperiph) * Relative compliance for each lobe (iClobe-rel) * Density of the lung parenchyma given per predefined lung zone (Ldens)

Countries

Belgium