Study to Assess the Effect of the NEXThaler® Device (DPI - Dry Powder Inhaler) on the Central and Peripheral Airway Dimensions in Asthmatic Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

June 30, 2013

Study Completion Date

June 30, 2013

Conditions
Asthma
Interventions
DRUG

Beclomethasone dipropionate 100 µg + formoterol fumarate 6 µg

In this trial, patients will take two inhalations of the beclometasone dipropionate 100 µg and formoterol fumarate 6 µg combination therapy (Foster®) using a Dry Powder Inhaler (NEXThaler®) device in the morning and two inhalations in the evening, for a total of 4 inhalations a day (total daily dose: BDP 400 µg / FF 24 µg).

RADIATION

CT thorax

"CT scan of the thorax will be performed at 2 time points: baseline and after 6 months of treatment.~The CT scan will be performed with low dose radiation using the multi-slice CT scan. Scanning will be performed at Functional Residual Capacity and Total Lung Capacity (2 times 8 sec). The lung volumes will be controlled using adapted spirometry during the CT procedure. The radiation dose will be reduced by reduction of the tube current and voltage. These settings depend on the patients' weight (1mAs/kg). In addition to this there will be an increase in noise factor to further reduce the radiation dose."

Trial Locations (1)

B-2650

University Hospital of Antwerp, Edegem (Antwerp)

All Listed Sponsors
collaborator

Chiesi Farmaceutici S.p.A.

INDUSTRY

lead

University Hospital, Antwerp

OTHER

NCT01650441 - Study to Assess the Effect of the NEXThaler® Device (DPI - Dry Powder Inhaler) on the Central and Peripheral Airway Dimensions in Asthmatic Patients | Biotech Hunter | Biotech Hunter