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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
16
CT-scan of thorax, at visit 2 pre and postdose and at visit 3 pre and postdose
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)
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)
Single dose of 2 puffs To ensure blinding, each patient will receive two inhalers (one active and one placebo) on each dosing day.
Single dose of 2 puffs To ensure blinding, each patient will receive two inhalers (one active and one placebo) on each dosing day.
Antwerp University Hospital
Edegem, Antwerp, Belgium
Total airway volume
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)
Time frame: At visit 2 (= 7-11 days after visit 1)
The number of deposited particles per pre-defined airway section
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)
Time frame: At visit 2 (= 7-11 days after visit 1)
Total airway resistance
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)
Time frame: At visit 2 (= 7-11 days after visit 1)
Total airway volume
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)
Time frame: At visit 3 (= 3-7 days after visit 2)
The number of deposited particles per pre-defined airway section
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)
Time frame: At visit 3 (= 3-7 days after visit 2)
Total airway resistance
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)
Time frame: At visit 3 (= 3-7 days after visit 2)
Lung function tests (spirometry, body plethysmography)
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).
Time frame: At visit 2 (= 7-11 days after visit 1)
Exercise capacity (6 minutes walking test)
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).
Time frame: At visit 2 (= 7-11 days after visit 1)
Dyspnea (BORG CR 10 scale and VAS dyspnea)
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).
Time frame: At visit 2 (= 7-11 days after visit 1)
Incidence of adverse events
The safety of the 2 products under investigation will be evaluated through monitoring of adverse events (AEs) throughout the study.
Time frame: From visit 1 until visit 4 = timeperiod of 3 à 4 weeks
Lung function tests (spirometry, body plethysmography)
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).
Time frame: At visit 3 (= 3-7 days after visit 2)
Exercise capacity (6 minutes walking test)
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).
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Time frame: At visit 3 (= 3-7 days after visit 2)
Dyspnea (BORG CR 10 scale and VAS dyspnea)
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).
Time frame: At visit 3 (= 3-7 days after visit 2)