Functional Respiratory Imaging
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1 Functional Respiratory Imaging (FRI) to assess the bioequivalence of inhaled medication Jan De Backer, MSc, PhD, MBA CEO BABE 2014
2 Functional Respiratory Imaging (FRI) FRI outcome parameters Added value in drug and device development Bio-equivalence Salmeterol/Fluticasone branded vs generic in asthma Salbutamol vs Ipratropium Bromide in COPD Conclusions OVERVIEW
3 CHALLENGES IN RESPIRATORY DRUG DEVELOPMENT Limited sensitivity of current Pulmonary Function Tests (FEV1, ) Very difficult to demonstrate efficacy of novel compounds, resulting in high number of patients needed in clinical trials Excessive respiratory drug development cost > $1.5 billion Difficult to demonstrate bioequivalence
4 AIM Explain Functional Respiratory Imaging (FRI) Demonstrate enhanced sensitivity wrt PFT Reduction in # patients required for clinical trials to understand mode of action Use clinical trials as a design tool in phase I and II To assess bioequivalence To de-risk phase III
5 FRI is an imaging biomarkers for respiratory diseases What are imaging biomarkers? IMAGING BIOMARKERS According to Wikipedia: A biomarker, or biological marker, generally refers to a measured characteristic which may be used as an indicator of some biological state or condition.
6 IMAGING BIOMARKERS Event Biomarker Intervention
7 IMAGING BIOMARKERS Event Biomarker Intervention
8 IMAGING BIOMARKERS Event Biomarker Intervention FUNCTIONAL RESPIRATORY IMAGING
9 FUNCTIONAL RESPIRATORY IMAGING (FRI) scan segment simulate flow
10 FUNCTIONAL RESPIRATORY IMAGING (FRI) High-resolution CT images are converted into patient-specific 3D computer models
11 FUNCTIONAL RESPIRATORY IMAGING (FRI) Computational Fluid Dynamics Solving Navier-Stokes equations numerically Computational grid Boundary conditions
12
13 FRI OUTCOME PARAMETERS Ventilation CT Inspiration and Expiration Perfusion & Tissue Deposition
14 FRI OUTCOME PARAMETERS Ventilation CT Inspiration and Expiration Perfusion & Tissue Deposition
15 Lobe volumes could be expressed as %p to assess hyper- or hypo inflation FRI: VENTILATION Lobar Volumes Patents EU US 61/ US PCT/EP2005/010730
16 FRI: VENTILATION Air Trapping Fraction of volume with HU <-850 on FRC scan
17 FRI: VENTILATION Airway Volumes Patents EU US 61/ US PCT/EP2005/010730
18 FRI: VENTILATION Airway Volumes Patents EU US 61/ US PCT/EP2005/010730
19 FRI: VENTILATION Airway Resistance Patents EU US 61/ US PCT/EP2005/010730
20 FRI: VENTILATION Image-based airway volume (ivaw) change Patents EU US 61/ US PCT/EP2005/010730
21 FRI: VENTILATION CFD-based airway resistance (iraw) change Patents EU US 61/ US PCT/EP2005/010730
22 FRI OUTCOME PARAMETERS Ventilation CT Inspiration and Expiration Perfusion & Tissue Deposition
23 FRI: PERFUSION Emphysema Patents EU US 61/ US PCT/EP2005/010730
24 FRI: PERFUSION Emphysema Patents EU US 61/ US PCT/EP2005/010730
25 FRI: PERFUSION Blood Vessels Patents EU US 61/ US PCT/EP2005/010730
26 FRI: PERFUSION Blood Vessels Patents EU US 61/ US PCT/EP2005/010730
27 FRI: TISSUE Airway Wall Thickness Patents EU US 61/ US PCT/EP2005/010730
28 FRI OUTCOME PARAMETERS Ventilation CT Inspiration and Expiration Perfusion & Tissue Deposition
29 FRI: DEPOSITION Aerosol Simulation DEVICE A DEVICE B
30 FRI: DEPOSITION Aerosol Simulation Device A Device B De Backer et al. Radiology 257 (2010) De Backer et al. Med Eng & Phys 30 (2008) Vinchurkar et al. Inhalation Toxicology (2012) 24(2): 81-8
31 FRI: DEPOSITION Aerosol Simulation Lung deposition increases by 9% Symbicort Device A Foster Device B mouth ua trachea lung mouth ua trachea lung
32 FRI: DEPOSITION Aerosol Simulation De Backer et al. Radiology Dec;257(3):
33 FRI: DEPOSITION Aerosol Simulation Regional concentration relative to a minimal inhibitory concentration threshold for inhaled antibiotics
34 FRI: DEPOSITION Aerosol Simulation
35 FROM MODE OF ACTION TO CLINICAL BENEFIT GEOMETRY PULMONARY FUNCTION PATIENT S QUALITY OF LIFE
36 FROM MODE OF ACTION TO CLINICAL BENEFIT Large sample size Effect on quality of life High # confounding factors Effect on pulmonary function Effect on geometry Small sample size site of action Low # confounding factors
37 CORRELATION BETWEEN GEOMETRY AND QOL Effect on quality of life Effect on pulmonary function Effect on geometry site of action
38 CORRELATION BETWEEN GEOMETRY AND QOL Wim Vos, Jan De Backer, Gianluigi Poli, Annick De Volder, Liesbeth Ghys, Cedric Van Holsbeke, Samir Vinchurkar, Lieve De Backer, Wilfried De Backer Use of novel functional imaging methods for the assessment of long-term changes in small airways of patients treated with extrafine beclomethasone / formoterol Respiration 2013
39 CORRELATION BETWEEN GEOMETRY AND PFT Effect on quality of life Effect on pulmonary function Effect on geometry site of action
40 CORRELATION BETWEEN GEOMETRY AND PFT
41 CORRELATION BETWEEN GEOMETRY AND PFT
42 SAMPLE SIZE CALCULATION Asthma Study Wim Vos, Jan De Backer, Gianluigi Poli, Annick De Volder, Liesbeth Ghys, Cedric Van Holsbeke, Samir Vinchurkar, Lieve De Backer, Wilfried De Backer Use of novel functional imaging methods for the assessment of long-term changes in small airways of patients treated with extrafine beclomethasone / formoterol Respiration 2013
43 SAMPLE SIZE CALCULATION COPD Study Lieve De Backer, Wim Vos, Jan De Backer, Cedric Van Holsbeke, Samir Vinchurkar, Wilfried De Backer Double blind, placebo controlled crossover study in COPD patients to assess the acute effect of budesonide/formoterol using multi-slice CT and lung function tests Eur Respir J 2012; 40:
44 Functional Respiratory Imaging (FRI) FRI outcome parameters Added value in drug and device development Bio-equivalence Salmeterol/Fluticasone branded vs generic in asthma Salbutamol vs Ipratropium Bromide in COPD Conclusions OVERVIEW
45 FRI TO BRIDGE BETWEEN PK AND PD Pharmacokinetics High ability to differentiate products FRI-based aerosol deposition FRI-based airway resistance (iraw) FRI-based airway volume (ivaw) FEV1 Low ability to differentiate products
46 double blind, double dummy, randomized, two-way cross-over study compare the effects of TEST = Seretide Evohaler (supplied by Allen & Hanburys, UK) REFERENCE = generic salmeterol/fluticasone HFA pmdi (manufactured by Cipla Ltd, India) functional respiratory imaging parameters in 16 asthmatic patients PROJECT OUTLINE
47 Primary: To evaluate the effect of both study drugs under investigation on FRI parameters and to evaluate the particle deposition in the lungs using CFD. ENDPOINTS Secondary: To assess the effect of salmeterol and fluticasone combination therapy on lung function (spirometry and body plethysmography), on exercise capacity (6MWT) and on dyspnea (Borg CR10 Scale and VAS dyspnea). Furthermore the safety of the 2 study drugs under investigation will be evaluated through monitoring of AEs throughout the study.
48 CLINICAL STUDY DESIGN Visit 2 (pre) Visit 2 (2h after pre) Visit 3 (pre) Visit 3 (2h after pre) Pre-bronchodilation - Imaging - PFT - Exercise tolerance Post-bronchodilation - Imaging - PFT - Exercise tolerance Pre-bronchodilation - Imaging - PFT - Exercise tolerance Post-bronchodilation - Imaging - PFT - Exercise tolerance Administration of TEST/REFERENCE with measurement of inhalation profile Administration of TEST/REFERENCE with measurement of inhalation profile
49 DATA COLLECTION CT scans: Pre-dose: FRC and TLC Post-dose: TLC Inhalation profile: Calibration of respiration belts with pneumotach Measurements during actual inhalation of study drug Pulmonary function tests: Spirometry Body plethysmography Exercise tolerance Dyspnea
50 INHALERS
51 Pre-dose/post-dose LA airway models Airway volumes (ivaw) Airway surface area (isaw) Airway resistance (iraw) Pre-dose internal airflow distribution For CFD boundary conditions Pre-dose coupled UA/LA/inhaler models for particle deposition simulations Regional deposition of inhaled compounds FRI OUTCOME
52 Pre-dose/post-dose LA airway models FRI OUTCOME V2_pre V2_post V3_pre V3_post Baseline stability, drug effect, effect comparison
53 Pre-dose internal airflow distribution For CFD boundary conditions FRI OUTCOME
54 Pre-dose coupled UA/LA/inhaler models for particle deposition simulations Regional deposition of inhaled compounds FRI OUTCOME 15.2%
55 Pre-dose coupled UA/LA/inhaler models for particle deposition simulations ACI data was used for particle diameter distribution of TEST and REFERENCE FRI OUTCOME
56 Pre-dose coupled UA/LA/inhaler models for particle deposition simulations Regional deposition of inhaled compounds FRI OUTCOME
57 STATISTICS To assess whether products are different Wilcoxon matched pairs to assess drug effect Mann Whitney U test to compare drug effects p<0.05 for significance To assess whether products are equivalent Two one-sided tests 90% confidence interval of Test/Reference ratio Between 80%-125% bounds
58 IN- AND EXCLUSION CRITERIA Inclusion Diagnosed asthma Treated according to GINA guidelines Non or ex-smokers (stopped <1y and <10y total packyears) Exclusion Exacerbation during last 8 weeks COPD Upper or lower airway infection Received oral corticosteroids in the last 4 weeks
59
60 9F/7M Mean SD Min Max Age [y] Height [cm] Weight [kg] BP Sys [mmhg] BP Dia [mmhg] HR [bpm] FVC [L] FVC [%p] FEV1 [L] FEV1 [%p] FEV1/FVC [%] PEF [L/s] MEF50 [L/s] FEF75 [L/s] FEF25 [L/s] RV [L] RV [%p] TLC [L] TLC [%p] FRC [L] FRC [%p] Raw [kpas/l] sraw [kpas] MWT [m] MWT [%p] PATIENTS
61 RESULTS
62 FRI-based airway Volume (ivaw) RESULTS
63 FRI-based airway resistance (iraw) RESULTS
64 Inhalation maneuver RESULTS
65 Drug deposition RESULTS
66 RESULTS FRI-based aerosol deposition test reference
67 RESULTS FRI parameters: drug effect IMAGING TESTS Pre Test Post Test Pre Reference Post Reference p-value Mean SD Mean SD Mean SD Mean SD p-value Total ivaw [cm 3 ] Central Distal Total isaw [cm 2 ] Central Distal Total iraw Central [kpas/l] Distal
68 RESULTS FRI parameters: drug comparison IMAGING TESTS Pre Test Pre Reference Change Test Change Reference p-value Mean SD Mean SD Mean SD Mean SD p-value Total ivaw [cm 3 ] Central Distal Total isaw [cm 2 ] Central Distal Total iraw Central [kpas/l] Distal
69 RESULTS Clinical parameters: drug effect CLINICAL TESTS Pre Test Post Test Pre Reference Post Reference p-value Mean SD Mean SD Mean SD Mean SD p-value FVC [L] FVC [%p] FEV1 [L] FEV1 [%p] FEV1/FVC [%] PEF [L/s] MEF50 [L/s] FEF75 [L/s] FEF25 [L/s] RV [L] RV [%p] TLC [L] TLC [%p] FRC [L] FRC [%p] R [kpas/l] sr [kpas] MWT [m] MWT [%p] SaO2 [%] SaO2_low [%] Borg_Dyspnea [0-10] pre 6MWT Borg_Dyspnea [0-10] post 6MWT
70 Clinical parameters: drug comparison RESULTS CLINICAL TESTS Pre Test Pre Reference Change Test Change Reference p-value Mean SD Mean SD Mean SD Mean SD p-value FVC [L] FVC [%p] FEV1 [L] FEV1 [%p] FEV1/FVC [%] PEF [L/s] MEF50 [L/s] FEF75 [L/s] FEF25 [L/s] RV [L] RV [%p] TLC [L] TLC [%p] FRC [L] FRC [%p] R [kpas/l] sr [kpas] MWT [m] MWT [%p] SaO2 [%] SaO2_low [%] Borg_Dyspnea [0-10] pre 6MWT Borg_Dyspnea [0-10] post 6MWT
71 Clinical parameters: drug comparison RESULTS CLINICAL TESTS Pre Test Pre Reference Change Test Change Reference p-value Mean SD Mean SD Mean SD Mean SD p-value FVC [L] FVC [%p] FEV1 [L] FEV1 [%p] FEV1/FVC [%] PEF [L/s] MEF50 [L/s] FEF75 [L/s] FEF25 [L/s] RV [L] RV [%p] TLC [L] TLC [%p] FRC [L] FRC [%p] R [kpas/l] sr [kpas] MWT [m] MWT [%p] SaO2 [%] SaO2_low [%] Borg_Dyspnea [0-10] pre 6MWT Borg_Dyspnea [0-10] post 6MWT
72 Seretide FS and Cipla FS are not significantly different Are they equivalent? Transform parameters to normal distributions (when needed) Determine 90% CI Assess whether 90% CI lies within 80%-125% bounds Case 1: Atrovent vs Ventolin Case 2: Seretide FS vs Cipla FS RESULTS
73 Assess acute effect of Salbutamol (Ventolin) in comparison with Ipratropium Bomide (Atrovent) Prospective cross over study 6 COPD patients ATROVENT vs VENTOLIN 400 microgram Ipratropium Bromide / 80 microgram Salbutamol Are these products equivalent according to different parameters? De Backer LA, Vos WG, De Backer JW, Devolder A, Verhulst SL, Claes R, Salgado R, Germonpré PR, De Backer WA The effect of salbutamol in comparison with ipratropium bromide on central and peripheral airways in COPD Int J Chron Obstruct Pulmon Dis. 2011;6:
74 ATROVENT vs VENTOLIN
75
76 ATROVENT vs VENTOLIN
77
78 CORRELATION BETWEEN GEOMETRY AND QOL COPD and Asthma Population (pooled data) 16 Data on file 5
79 CORRELATION BETWEEN GEOMETRY AND QOL COPD and Asthma Population (pooled data) -19 Data on file 5
80
81
82 FRI TO BRIDGE BETWEEN PK AND PD Pharmacokinetics High ability to differentiate products FRI-based aerosol deposition FRI-based airway resistance (iraw) FRI-based airway volume (ivaw) FEV1 Low ability to differentiate products
83 CONCLUSIONS FRI is more sensitive compared to standard PFT FRI can yield regional information in small scale clinical trials FRI has the potential to bridge between PK and PD
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