Visualization of the improvement of nasal flow with Nasonex

1
Visualization of the improvement of nasal flow
with Nasonex

• Prof. Dr. med. Ralph Mösges, FAAAAI
• Otorhinolaryngologist and allergologist,
• MSEE informatics
• Institute of Medical Statistics, Informatics and
  Epidemiology
• University of Cologne, Germany

2
Visualization of the improvement of nasal flow
with Nasonex

• Objective
• Methods
• Results
• Conclusion

3
Objective

• 3D visualization of the nasal flow to demonstrate
  the
• anti-obstructive effect of Nasonex

4
Methods
5
Methods - study conduction

• ? Monocentric clinical trial in one patient
• Inclusion criteria
• Patient with seasonal allergic rhinitis due to
  pollen allergy
• Two years diagnosis of the allergic rhinitis
• Significant swelling of the mucus membranes after
  allergen challenge

6
Methods - study flow chart
Rhinomanometry
Rhinomanometry
Rhinomanometry
Rhinomanometry
Acoustic rhinometry
Acoustic rhinometry
Acoustic rhinometry
Acoustic rhinometry
Allergen challenge
MRT 1
MRT 3
Allergen challenge
Rhinomanometry
Allergen challenge
Acoustic rhinometry
Rhinomanometry
Rhinomanometry
Exclusion/ inclusion criteria
Acoustic rhinometry
Acoustic rhinometry
MRT 2
MRT 4
Day -7 Visit 1
Day 0 Visit 2
Day 7 Visit 3
Day 14 Visit 4
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Methods - Acoustic rhinometry
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Methods - Rhinomanometry
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Methods surface extraction of the nasal cavity
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Methods - flow simulation

• Development of a flow solver for the complex
  geometry of the nasal cavity
• Simulation of the flow field
• Post processing of the results (determining of
  pressure loss, computing streamlines)
• Visualization in a virtual reality environment

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Visualization of the improvement of nasal flow
with Nasonex
Results
12
Results - subject evaluation
Day -7 after allergen challenge
Day 14 after allergen challenge
2
2
nasal congestion
0
2
sneezing
2
2
itching
0
2
rhinorrhea
0 absent 1 mild 2 moderate 3 severe
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Results - subject evaluation

• Subject global assessment of treatment efficacy
• Subject reported moderate symptom relief
• 1 significant relief 3 little relief
• 2 moderate relief 4 no relief
• Subject assessment of treatment satisfaction
• Subject was satisfied with treatment
• 1 very satisfied 3 somewhat satisfied
• 2 satisfied 4 dissatisfied

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Results - investigator survey

• Investigator efficacy and tolerability
  assessment
• efficacy ? 2
• tolerability ? 1

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Results - Rhinomanometry
Day -7
Nasal flow at 150 Pa
Day 0
Day 14
Nasal cavity right baseline
244ml/s
126 ml/s
218 ml/s
Nasal cavity left baseline
141 ml/s
164 ml/s
175 ml/s
Total flow baseline
385 ml/s
290 ml/s
398 ml/s
Nasal cavity right after challenge
55 ml/s
142 ml/s
189 ml/s
Nasal cavity left after challenge
140 ml/s
154 ml/s
135 ml/s
Total flow after challenge
195 ml/s
296 ml/s
324 ml/s
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Results - Rhinomanometry

• At day -7 the baseline volume flow was within the
  normal range
• ?after allergen challenge the volume flow
  decreased significantly
• At day 0 the baseline volume flow was reduced
• ?allergen challenge demonstrated no positive
  reaction to the allergen
• At day 14 the baseline volume flow was within the
  normal range
• ?after allergen challenge the flow decreased
  but less significant than on day -7

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Results - Rhinomanometry
Rhinomanometry day 0, baseline? initial slope
angle for the right nasal cavity flow 38??
initial slope angle for the left nasal cavity
flow 41
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Results - Rhinomanometry
Rhinomanometry day 0, after allergen challenge?
initial slope angle for the right nasal cavity
flow 34?? initial slope angle for the left
nasal cavity flow 40?
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Acoustic rhinometry
Day -7
Cross sectional values
Day 0
Day 14
Nasal cavity right baseline
34 ml
28 ml
31 ml
Nasal cavity left baseline
28 ml
36 ml
25 ml
Total volume baseline
62 ml
64 ml
56 ml
Nasal cavity right after challenge
27 ml
23 ml
30 ml
Nasal cavity left after challenge
21 ml
28 ml
32 ml
Total volume after challenge
49 ml
50 ml
62 ml
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Results Acoustic rhinomanometry

• At day -7 the cross sectional baseline value was
  within the normal range
• ?after allergen challenge the value decreased
  significantly
• At day 0 the cross sectional baseline value was
  within the normal range
• ?after allergen challenge the value decreased
  significantly
• At day 14 the cross sectional baseline value was
  within the normal range
• ?after allergen challenge the value increased

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Acoustic rhinometry

• On day -7 and day 0 the cross sectional values
  decrease after allergen challenge
• On day 14 there is an increase of the cross
  sectional value

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nasal cavity surface
Results - surface extraction
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Results - flow simulation
Regio olfactoria
Pharynx
Nasal valve
flow streamlines
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Results - flow simulation
Upper meatus
Middle meatus
Lower meatus
Nasal valve
longitudinal cut planes
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Results - flow simulation
Plane displayed
Nasal valve
Pharynx
day 0 baseline
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Results - flow simulation
Plane displayed
Pharynx
Nasal valve
day 0 baseline
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Results - flow simulation
Plane displayed
Pharynx
Nasal valve
day 0 after allergen challenge
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Results - flow simulation
Plane displayed
Pharynx
Nasal valve
day 0 after allergen challenge
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Results - flow simulation
Plane displayed
Nasal valve
Pharynx
day 14 baseline
30
Results - flow simulation
Plane displayed
Nasal valve
Pharynx
day 14 baseline
31
Results - flow simulation
Plane displayed
Nasal valve
Pharynx
day 14 after allergen challenge
32
Results - flow simulation
Plane displayed
Nasal valve
Pharynx
day 14 after allergen challenge
33
Results - flow simulation
day 0 baseline
34
Results - flow simulation
day 0 after allergen challenge
35
Results - flow simulation
day 14 baseline
36
Results - flow simulation
day 14 after allergen challenge
37
Conclusion

• First nasal challenge experiment documented by
  MRI with prophylactic INS treatment
• Proof of concept that MRI data can be used for
  computational fluid dynamics (CFD) modeling
• Anti-obstructive effect of Nasonex can be
  depicted in 3D

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Visualization of the improvement of nasal flow
with Nasonex

• Prof. Dr. med. Ralph Mösges, FAAAAI
• Otorhinolaryngologist and allergologist,
• MSEE informatics
• Institute of Medical Statistics, Informatics and
  Epidemiology
• University of Cologne, Germany
• Ralph_at_Mosges.com