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3. To Breathe or Not To Breathe- That Is Not the Question: Access & Delivery of Inhaled CF Medications Kathleen Richards, RRT Primary Children’s Hospital Salt Lake City, UT

4. Presenter Disclosure Kathleen Richards, RRT
The following relationship(s) exist(s) related to this presentation:
Novartis Pharmaceuticals Corporation, Speaker Bureau

5. Factors that Influence Deposition
Wasted Drug
Ventilation Distribution
Timing of therapies
Adherence
Patient age
Inhalation Technique
Device/ Equipment David E. Geller
“Which Nebulizer For Which Drug”
2006 Cystic Fibrosis Foundation

6. Aerosol Drug Administration
Nebulizers
Unvented Nebulizer (T-piece)
Sidestream Nebulizer
Breath Enhanced Nebulizer
Breath Actuated Nebulizer
Ultrasonic Nebulizer
Vibrating Perforated Membrane Technology Nebulizer

7. Unvented Nebulizer (T-piece)
Has only one inlet, which is the driving flow for the nebulizer
Has one outlet, which is either a T-piece and mouthpiece or a face mask for children too small to use a mouthpiece

8. Unvented Nebulizer (T-piece)
Advantages:
Output is independent of patients’ respiratory status
Inexpensive
Disadvantages:
The aerosol is diluted as extra air is inhaled through back of T-piece
Degradation of particle size distribution with repeated use (with unknown clinical implications)
Plastic unable to withstand the proper cleaning and disinfecting guidelines from the CFF
Decreased portability, requires a compressor needing AC outlet or batteries

9. Sidestream® Nebulizer
Uses another method of shearing the liquid solution into an aerosol. Instead of shearing the liquid at a 90 degree angle, it takes place over the surface of the liquid.
Air is drawn into the nebulizer all during nebulization.

10. Sidestream® Nebulizer
Advantages:
Output is independent of patients’ respiratory status
Approved for use with Pulmozyme® and is a reasonable choice for Colistin
Able to clean and disinfect following certain approved CFF guidelines
(See manufacturers’ recommendations)
Longer warranty than disposable nebulizers
Disadvantages:
More waste of medication during exhalation (fine for some drugs like bronchodilators, dornase alfa, or hypertonic saline, but it is not a good choice for dose-dependent drugs like antibiotics.)
Decreased portability, requires a compressor needing AC outlet or batteries

11. Breath Enhanced Nebulizers
Minimize drug loss during exhalation by entraining the inspiratory flow of the patient through the nebulizer.
Particles are able to be swept into the airway because of the enhanced flow
During expiration, increased rain-out occurs and the drug returns to the reservoir for re-nebulization.

12. Breath Enhanced Nebulizers
Advantages:
Delivers 2-4 times more drug to the lung than a T-piece or Sidestream® nebulizer
Less waste of medication during exhalation
The Pari LC Plus® is the nebulizer approved for use with TOBI® solution/ tobramycin solution, Bethkis ®, and Kitabis Pak ®
Able to clean and disinfect following certain approved CFF guidelines.
(See manufacturers’ recommendations)
Longer warranty than disposable nebulizers
Disadvantages:
Decreased portability, requires a compressor needing AC outlet or batteries

13. Breath Actuated Nebulizers
Medication is delivered during inspiration
Conserves medication during exhalation
Avoidance of emission of drug into environment

14. Breath Actuated Nebulizers
Advantages:
Increased fine particle mass compared with breath- enhanced nebulizer
Capable of being used in continuous or breath actuated mode
Able to clean and disinfect following certain approved CFF guidelines
Longer warranty than disposable nebulizers
Disadvantages:
Compressor or air output can affect delivered drug dose. Dosing protocols may need to be adjusted
Decreased portability, requires a compressor needing AC outlet or batteries

15. Compressors
Jet nebulizers are powered by an electric compressor to make an aerosol. Standard compressor output pressure- 25 psi
Particle size and output may vary when using different nebulizer/compressor systems
More powerful compressors (i.e., Mobilaire) generate high pressures and airflow, resulting in smaller droplets and shorter treatment times, with more drug wasted during exhalation
Battery operated compressors make travel more convenient, but not as powerful (i.e., PariTrek). Lower pressures, make larger droplets and may decrease deposition of drug into the lungs and result in longer treatment times

16. Vibrating Perforated Membrane Nebulizers
The eFlow® class of nebulizers forces a liquid drug through a thin, vibrating steel mesh membrane
The membrane rapidly vibrates forcing the liquid drug through the tiny laser-drilled holes creating an aerosol mist
Three current versions: Trio®, Altera®, eRapid®

17. Vibrating Perforated Membrane Nebulizers
Trio®
Studies currently being performed, not approved for use with all drugs
Due to its high efficiency and delivery of twice the predicted aerosol deposition, it is recommended that the dose of some drugs (e.g., antibiotics, bronchodilators, etc.) may need to be reduced to avoid side effects
Altera®
Similar to Trio® in function and handset components
Vibrating mesh is unique to the Altera®, therefore only FDA approved for use with Cayston®
Minimal medication left in medication reservoir
eRapid®
General use nebulizer designed to deliver same aerosol output and drug deposition as Pari LC® Plus nebulizer, but in half the time
Approximately 1 mL of medication left in reservoir after treatment
Currently felt any drug approved for use in Pari LC® Plus can be used in eRapid® (lacks FDA approval for use with TOBI®)

18. Vibrating Perforated Membrane Nebulizers
Advantages:
Increased portability (small size and has an option for battery power operation, doesn’t require a compressor)
2-4 times more efficient at creating small particles than current systems resulting in faster treatment times
One-way valve in the aerosol chamber diverts exhaled air and minimizes waste during the expiratory phase
The base controller unit is similar between the three devices and can be used with multiple handsets
Disadvantages:
Metal mesh membrane is delicate and must be handled carefully. It is not recommended that the membrane itself be touched, even with clean hands
Drug suspensions containing larger particle size (e.g., Pulmicort Respules®) may clog the membrane. Additionally, increased use can result in longer treatment times
Salt condensates may corrode the membrane (Rinsing immediately after use with hypertonic saline is recommended.)
Each type of eFlow® nebulizer is specific to its own version of vibrating mesh membranes, aerosol chambers and medication reservoirs. Confusion may result if using more than one type of device for various inhaled medications

19. TOBI Podhaler®
Tobramycin inhalation powder (TIP) comes in 4 capsules of 28 mg each (per dose= 112 mg total) to be taken twice a day
Each treatment cycle is 28 days on drug, followed by 28 days off drug (unless otherwise prescribed by a physician)
Each capsule contains the aminoglycoside tobramycin which is used in the treatment of Pseudomonas Aeruginosa

20. TOBI Podhaler® Advantages: Portable delivery device
Medication does not need to be refrigerated
Podhaler does not need to be sterilized. Wipe dry after each use. One new Podhaler device is provided for each week
Dosing takes a few minutes compared to 20+ minutes to nebulize liquid solution
Disadvantages:
Not studied in children <6 years old
Not studied in patients with an FEV1 <25%
Side effects include: excessive coughing, shortness of breath, sore throat, etc.

21. DPI Advantages: Shorter treatment times Portable
Breath actuated (easier to use for patients with poor MDI technique)
Disadvantages:
Oropharyngeal deposition
Water soluble, so humidity may affect performance
Throat irritation
Minimum inspiratory flowrate required for full drug efficacy
* Young children may not be able to generate this flowrate and may not be a candidate for this system

22. Special Considerations
Do not mix medications in the same nebulizer unless proven to be compatible
Use separate nebulizers for each medication needing to be administered
Use a mouthpiece whenever possible (moving the mask just 2cm away from the face may reduce the delivery of nebulized drug by up to 85%; in addition, nasal deposition further reduces airway deposition)
Be aware of, and advise patients, when a nebulizer should be replaced, e.g., manufacturer’s warranty, longer treatment times reported by patient- average treatment times minutes
Instruct patient in proper cleaning and disinfecting of equipment based on Infection Prevention and Control Guidelines and manufacturer’s recommendations
Instruct patients on how each medication should be stored e.g., refrigerator (TOBI® solution, Cayston®), room temperature (TOBI Podhaler®), travel considerations and any special mixing concerns (Colistin)
Be aware of possible adverse side effects for each medication, e.g., bronchospasm, hoarseness/voice changes, increased cough, sore throat, loss of taste or hearing
M Everard Arch Dis Child 1992; 67:
Infection Prevention and Control Guidelines for Cystic Fibrosis: 2013 Update, Infection Control and Hospital Epidemiology August 2014, Vol.35,No. S1

23. Future Inhaled Antibiotics
Aeroquin®
Arikace ®
AeroVanc ®