NCT01795664 - Compare the Effects of Seretide® Evohaler and a Generic Salmeterol/Fluticasone Hydrofluoroalkane (HFA) Pressurized Metered-dose Inhaler (pMDI) on Functional Respiratory Imaging Parameters in Asthmatic Patients | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

August 31, 2013

Study Completion Date

August 31, 2013

Conditions

Asthma

Interventions

RADIATION

Functional Respiratory Imaging

CT-scan of thorax, at visit 2 pre and postdose and at visit 3 pre and postdose

DRUG

Salmeterol xinafoate and Fluticasone propionate HFA pMDI

"Strength: 25/250 mcg per actuation; Dose: single dose of 2 puffs; A total dose of 50/500 mcg~At visit 2 or visit 3 (cross-over design)"

DRUG

Seretide Evohaler

"Strength: 25/250 mcg per actuation; Dose: single dose of 2 puffs; A total dose of 50/500 mcg~At visit 2 or visit 3 (cross-over design)"

DRUG

Placebo of Test product

"Single dose of 2 puffs~To ensure blinding, each patient will receive two inhalers (one active and one placebo) on each dosing day."

DRUG

Placebo of Reference product

"Single dose of 2 puffs~To ensure blinding, each patient will receive two inhalers (one active and one placebo) on each dosing day."

Trial Locations (1)

Antwerp University Hospital, Edegem