Debbie Kennedy on Oral antifungals and TDM, Khaled Al-Shair- 4 things we have learned from QOL, Phil Langridge- Correct use of inhalers

1. Support Meeting for
Aspergillosis Patients
LED BY GRAHAM ATHERTON
SUPPORTED BY
GEORGINA POWELL, DEBBIE KENNEDY & DEB HAWKER
NAC CENTRE MANAGER CHRIS HARRIS
ORAL ANTIFUNGAL: DEBBIE KENNEDY
NATIONAL ASPERGILLOSIS CENTRE
UHSM
MANCHESTER
Fungal Research Trust

2. Programme
 1.30 Debbie Kennedy Oral antifungals and TDM
 2.00 Khaled Al-Shair- 4 things we have learned from QOL
 2.20 Break
 2.30 Phil Langridge- Correct use of inhalers
 2.50 Graham Atherton Short story on some recent
research/discuss social support via phone
 3.10 Q & A

3. Monitoring Drug Levels
25th January 2013
NAC Patient’s Meeting

4. Drugs that are used to treat Aspergillosis
– There are 3 oral drugs that are used to treat
aspergillosis
– Itraconazole
– Voriconazole
– Posaconazole
– Known as azoles

5. Why monitor drug levels?
– It is important that the concentration of the
drug in the body is kept within a threshold for
it to suppress the fungus
– It may be effective below the lower expected
level but this runs the risk of resistance
– Above the higher level may mean the patient
experiences side effects or increased side
effects

6. Drug Management
 Itraconazole is available as 100 mg pink and blue capsules with the brand
name brand name Sporanox.® Always remember it is very important to take
the Itraconazole capsules whole with food or an acidic drink,
like coca-cola.
 Itraconazole is available as an oral liquid again with the brand name
Sporanox® and comes in a 150ml bottle with a concentration of 10mg/mL. It is
sugar free and is cherry flavoured. Always remember it is very important to
take Itraconazole oral liquid on an empty stomach.

7. Drug Management
 Voriconazole is available as 50mg or 200mg tablets with the brand name Vfend®
should be taken at a dose of 200mg twice daily, 12 hours apart. Voriconazole, brand
name Vfend® is also available as an orange flavoured oral liquid of 200mg/5mL.
 The amount of Voriconazole in your body is measured through a small blood test. This
helps us to make sure you are on the right dose for you, that is, not too much or not too
little.

8. Drug Management
Posaconazole is available only as an oral liquid 200mg/mL
Noxafil® and should be taken at a dose of 400mg twice daily,
12 hours apart, with food.
If patients cannot tolerate food it should be taken 200mg 4
times daily.

9. Drug Management
~£109.20
~£109.20 ~£4410.96
~£4410.96
28 days
28 days 28 days
28 days
~£3000.00
~£3000.00
28 days
28 days

10. Therapeutic Drug Monitoring
TDM
• Itraconazole Levels – random level
• Voriconazole Levels – trough level
• Posaconazole Levels – record time of last dose
Aim is to keep blood concentration at a therapeutic level
• Too low can lead to resistance
• Too high can result in increased side effects

11. Side effects of Azoles
Itraconazole
• GI Intolerance
• Hepatitis
• Peripheral neuropathy
• Fluid retention
• Rash
• Hypertension
• Cardiac Failure
• Headache
• Tremor
• Insomnia

12. Side effects of Azoles
Voriconazole
• Photosensitivity – even trivial light Visual
Disturbance
• Peripheral neuropathy
• Poor concentration
• Abnormal thinking
• Headache
• Dry painful lips
• Abnormal LFTs
• Dry eyes
• Tightening feeling of the skin

13. Side effects of Azoles
Posaconazole
• GI Intolerance
• Neuropathy
• Rash
• Headache
• Sleep disturbance
• Anorexia
• Abnormal LFTs
• Arrhythmias & palpitations

14. TDM as part of Long Term Management
Blood tests
Aspergillus precipitins and titre
Inflammatory markers, CRP, Plasma Viscosity
Total IgE
Aspergillus specific IgE (RAST)
Microscopy
Sputum – sensitivities Asp PCR
Radiology
X-ray
CT scan
History
MRC – Medical Research Council Dyspnoea Score

15. www.aspergillus.org.uk

16. Measuring health status in
Chronic pulmonary aspergillosis
(CPA): lessons we have learned
Dr Khaled Al-shair MD PhD
National Aspergillosis Centre
South Manchester University Hospital

17. A year ago, we discussed:
1. What is chronic pulmonary aspergillosis
(CPA)?
2. What is aspergillus?
3. Is there a standardized measure to assess these
most frequent symptoms of the disease, its
burden on physical, social, cognitive and
psychological aspects of life?
4. What this questionnaire stands for?
5. What are the components of this questionnaire?
6. Is it valid and standardized?
7. Why I should fill the questionnaire every three
months?

18. How important to have regular
and frequent assessment?

19. • The disease is slowly progressive if left with out
treatment and monitoring,
• Further destruction to the lung tissue may happen,
• More cavities or aspergilloma may develop,
• More symptoms e.g., shortness of breath, fatigue,
haemoptysis or loss of weight

20. How the disease is regularly
monitored?

21. Radiology
Laboratory investigation
Standard symptomatology measurement
(Patients Reported Outcomes)

22.  The 50 items of the SGRQ -
which cover 76 levels - are
sub-scaled to three main
aspects.
 The first 8 items cover the
respiratory symptoms and
their frequency and severity,
the Symptom domain.
 The next 16 items concern
limitation in activities due to
shortness of breath, the
Activity domain.
 The last 26 items cover the
consequent social and
psychological implications of
the respiratory diseases, the
Impact domain. The scale
covers 0-100; the higher the
score, the worse the health
status.

23. I am really keen to use my medication,
does that help me, when I may see
improvement?

24. Improved Stable Deteriorated
n= 107 97 44 n= 37 31 14 n= 27 28 16 n= 41 36 13
All patients Itraconazole Voriconazole Posaconazole
Response after treatment for 3, 6 or 12 months on either
itraconazole, voriconazole or posaconazole

25. Do all patients get improved?

26. After treatment:
- 47-50% gained substantial health improvement
with a reduction of score of 14 at both 6 and 12months,
- 32% deteriorated with a rise of 11 and 14 scores after 6
and 12 months of treatment and observation respectively,
- 21% were not much different (stable).

27. n= 107 97 44 n= 37 31 14 n= 27 28 16 n= 41 36 13
All patients Itraconazole Voriconazole Posaconazole
Response after treatment for 3, 6 or 12 months on either
itraconazole, voriconazole or posaconazole
Improved Stable Deteriorated

28. I’ve been told that my case is poor/very
poor, ANY HOPE to get better?

29. Patients gained therapeutic benefit irrespective of their
illness severity where >50% of those who had “poor”
and “very poor” at baseline improved with reduction of
≥4 scores after 6 months of treatment.
Using much wider scale, we found that at least 50% of
“poor/very poor” health status category at baseline
improved significantly to “fair” or “good/very good”
categories.

30. Good/Very good
Fair
Poor/Very poor
n= 18 18 51 51 44 38
At baseline Good/Very good Fair Poor/Very poor
Changes in health status at 6 and 12 months from baseline

31. Thank you

32. How To Use Your Inhaler
Reyenna Sheehan
Specialist Aspergillosis Physiotherapist
25/1/13

33. Inhalers
• Device used to deliver medication to the lungs
in an aerosol form

34. Metered-Dose Inhaler (MDI)
• Pressurised aerosol inhaler
• How to use:
• Remove Cap
• Shake canister
• Place mouthpiece in mouth
• Press Canister once to release a dose of drug
• Breathe in
• Hold breath 10 seconds
• If another dose is needed take inhaler out of
mouth, shake and repeat above steps

35. Using MDI with Spacer
• Remove cap and insert inhaler into
aerochamber/spacer
• Place mouthpiece in mouth and take slow
breath in
• Whistles if breathe too quickly
• Can be used with or without breath hold

36. Easi-breathe
• Breath Activated
• Shake inhaler and open cap
• Hold upright and breathe out gently
• Place mouthpiece in mouth
• Breathe in slowly and deeply
• Hold for 10 seconds and remove inhaler from
mouth

37. Accuhaler
• Dry powder inhaler
• Open lid fully
• Slide lever down until it clicks to load inhaler
• Breathe out gently
• Place mouthpiece in mouth
• Take deep breathe in
• Hold Breath 10 seconds and remove
mouthpiece

38. Turbohaler
• Dry powder inhaler
• Remove lid
• Hold upright and twist forwards and
backwards (should hear a click)
• Breathe out gently
• Place inhaler in mouth and take deep breathe
in

39. HandiHaler
• Open cap
• Open mouthpiece
• Remove capsule from blister and place in chamber
• Close mouthpiece until it clicks
• Press green button in once and release
• Breathe out gently away from mouthpiece
• Put mouthpiece between teeth without biting and close lips to form good seal
• Breathe in slowly and deeply, so capsule vibrates
• Continue to breathe in as long as comfortable
• While holding breath, remove inhaler from mouth
• Breathe out gently away from mouthpiece
• Put mouthpiece back between teeth without biting and close lips to form good seal
• Breathe in slowly and deeply again, so capsule vibrates
• Continue to breathe in as long as comfortable
• While holding breath, remove inhaler from mouth
• Breathe out gently away from mouthpiece
• Open mouthpiece and remove used capsule
• Close mouthpiece and cap

40. Final Thought….
• Remember intended purpose!
• Please use medication as advised and
prescribed by your medical practitioner

42. Social Support
Online support groups – support around 1250 people
But 49% of our patients are not online – reasonable to
suggest that this is representative?
Offline support – How?

43. Offline Support
This meeting!
About 12-16 people per month – estimate 50 people per year
How many here access support online?
What proportion of the ‘offline people’ are we reaching?

44. Offline support
Local support groups
7 groups in the UK (all in England)
3-6 people per group = a maximum of 40 people
Some of these are new people (not our patients)
Many of these are offline – approx 50%

45. Offline Support – How?
Still left with people who cannot reach support
groups – mobility problems, access to IT, socially
awkward
Everyone gets newsletter in clinic – so all of OUR
patients are reachable
Everyone has a phone!

46. New Year Honours List
A extraordinary man was honoured for organising &
providing a phone support service to a large group of
patients

47. Peer support service

48. Volunteer Phone Support - discussion
Suggestions
We ask for volunteers who are already ‘expert
patients’ – e.g. come to this meeting, use online
support, experienced
Volunteers man a phone line for a short time each
week
Clinic puts people in touch – i.e. volunteers phone
number is not publicised
Doctors/nurses will suggest people who need
support and who cannot use current support

49. What would phone support consist of?
Social contact – informal
Empathy
An intermediary for information

50. Your opinions
Is this a workable idea?
What would be a reasonable time to ask someone to
volunteer?
How frequently?
Do you think training would be needed?
Should we try to protect personal home numbers
somehow?

51. Vote
Is this a good idea?
Is this the right way to go about it?
What changes should we make before starting?
Any volunteers – help us run service and help us
decide what to do?

52. Thank You
“The best chance we have of beating this illness is to
work together”
Living with it, Working with it, Treating it
Fungal Research Trust