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

A Double Blind, Double Dummy, Randomized, Two Way Cross-over Study to Compare the Effects of Seretide® Evohaler (Supplied by Allen & Hanburys, UK) and a Generic Salmeterol/Fluticasone HFA pMDI (Manufactured by Cipla Ltd, India) on Functional Respiratory Imaging Parameters in Asthmatic Patients.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: FLUIDDA nv · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will be conducted as a randomized, double blind, double dummy two period crossover study in stable asthma patients. A total of 16 stable asthma patients treated in accordance with the Global Initiative for Asthma (GINA) guidelines, will be included. Objectives: * The primary objective of this study is to evaluate the effect of both the study drugs under investigation on Functional Respiratory Imaging (FRI) parameters and to evaluate the particle deposition in the lungs using Computational Fluid Dynamic (CFD) * The secondary objectives are to assess the effect of both the study drugs on lung function (spirometry and body plethysmography), on exercise capacity (6 Minutes Walking Test = 6MWT) and on dyspnea (Borg Category (C) Ratio (R) 10 Scale and Visual Analog Scale (VAS) dyspnea). Furthermore the safety of the 2 products under investigation will be evaluated through monitoring of adverse events (AEs) throughout the study.

Conditions

• Asthma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-03-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2013-02-21
• Last updated: 2013-09-19

Locations

1 site across 1 country: Belgium