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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.
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.
Details
| Lead sponsor | FLUIDDA nv |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 16 |
| Start date | 2013-03 |
| Completion | 2013-08 |
Conditions
- Asthma
Interventions
- Functional Respiratory Imaging
- Salmeterol xinafoate and Fluticasone propionate HFA pMDI
- Seretide Evohaler
- Placebo of Test product
- Placebo of Reference product
Primary outcomes
- Total airway volume — At visit 2 (= 7-11 days after visit 1)
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 number of deposited particles per pre-defined airway section — At visit 2 (= 7-11 days after visit 1)
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) - Total airway resistance — At visit 2 (= 7-11 days after visit 1)
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) - Total airway volume — At visit 3 (= 3-7 days after visit 2)
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 number of deposited particles per pre-defined airway section — At visit 3 (= 3-7 days after visit 2)
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) - Total airway resistance — At visit 3 (= 3-7 days after visit 2)
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)
Countries
Belgium