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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005789-36 | EudraCT Number | ||
| E-RES/12/12-Q13 | Other Identifier | Cipla Ltd, India |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Seretide Evohaler | Active Comparator | Salmeterol xinafoate and Fluticasone propionate combination HFA pMDI (Seretide Evohaler, Allen & Hanburys, UK) Strength: 25/250 mcg per actuation; Dose: single dose of 2 puffs; a total dose of 50/500 mcg |
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| Salmeterol xinafoate and Fluticasone propionate HFA pMDI | Experimental | Salmeterol xinafoate and Fluticasone propionate combination HFA pMDI (Cipla Ltd., India) Strength: 25/250 mcg per actuation; Dose: single dose of 2 puffs; a total dose of 50/500 mcg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional Respiratory Imaging | Radiation | CT-scan of thorax, at visit 2 pre and postdose and at visit 3 pre and postdose |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | 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) | 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) | 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) | At visit 3 (= 3-7 days after visit 2) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At visit 2 (= 7-11 days after visit 1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wilfried De Backer, MD, PhD | University Hospital, Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antwerp University Hospital | Edegem | Antwerp | 2650 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27227384 | Derived | De Backer J, Van Holsbeke C, Vos W, Vinchurkar S, Dorinsky P, Rebello J, Mangale M, Hajian B, De Backer W. Assessment of lung deposition and analysis of the effect of fluticasone/salmeterol hydrofluoroalkane (HFA) pressurized metered dose inhaler (pMDI) in stable persistent asthma patients using functional respiratory imaging. Expert Rev Respir Med. 2016 Aug;10(8):927-33. doi: 10.1080/17476348.2016.1192464. Epub 2016 Jun 1. |
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| Salmeterol xinafoate and Fluticasone propionate HFA pMDI | Drug | 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) |
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| Seretide Evohaler | Drug | 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) |
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| Placebo of Test product | Drug | Single dose of 2 puffs To ensure blinding, each patient will receive two inhalers (one active and one placebo) on each dosing day. |
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| Placebo of Reference product | Drug | Single dose of 2 puffs To ensure blinding, each patient will receive two inhalers (one active and one placebo) on each dosing day. |
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| 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) | 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). | 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). | 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. | 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). | 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). | 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). | At visit 3 (= 3-7 days after visit 2) |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068299 | Salmeterol Xinafoate |
| ID | Term |
|---|---|
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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