july 2005 july 2005 effectiveness zthe novolizer® is robust, can be used every day, twice a day for...
TRANSCRIPT
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Novolizer®Technical Aspects
Dr JosDr Joséé MMªª Negro AlvarezNegro Alvarez
H.U. H.U. ““Virgen de la ArrixacaVirgen de la Arrixaca””. Murcia (Espa. Murcia (Españña)a)
Profesor Asociado de AlergologProfesor Asociado de Alergologíía. Universidad de Murcia (Espaa. Universidad de Murcia (Españña)a)
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Contents
Design and function of the Novolizer®
Performance and efficacy, characteristics, robustness and reliability– in-vitro– in-use
Conclusions
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Features of the Novolizer®
Easy and safe handling– Multiple feed back mechanism (audible, visual, sensoric)– Low intrinsic resistance – System preventing inadvertent multiple dosing– Dose counter linked to correct inhalation– Pocket-sized– No ingression of microorganisms
Excellent accuracy / precision– Consistent dose metering and delivery– Relative independence of particle size on flow rate– Ensured deposition of therapeutic agent in the bronchial tree– High respirable fraction, good efficacy– Reliable and durable
Advanced technology– Multidose– Unique and superior dispersion system
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Cartridge
Powder
Dosing channel
Dosing chamber
Novolizer® - What’s in there ? (1)
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Mouth piece
Powder channel
Dosage button
Tapper
Novolizer® - What’s in there ? (2)
Dosing scheme and inhalation mechanism
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Cyclone
Laminar flow
Novolizer® - What’s in there ? (3)
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Assured asthma drug delivery
Remove cap
Press the dosage button- patient hears a double click- colour change in inhalation window from red togreen
Inhale deeply- a ‘click’ indicates drug has been released
Guaranteed drug deposition in the lungs
There is only one way to use the Novolizer® ...... the right way !
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Operation of the Novolizer® (1)
Press dosage button (dosage counter will be activated)
Device is ready for inhalation: colour change in inhalation window fromred to green
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Operation of the Novolizer® (2)
Inhale with maximum inspiratory effort(deeply and strongly, only an inspiration >35 l/min is necessary)
Inhalation was successful: color change from green to red
Cover mouth piece with cap
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Easy cartridge change
Remove slide cap
Remove empty cartridge
Replace with new cartridge
Replace slide cap
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Multiple control feedback mechanism
Indicates successful inhalation
Guarantees inhalation of a correct & exact single dose, providing the patient with confidence, security, assurance and reassurance
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Easy to use for most asthmpatients
Conclusion:The Novolizer is easy to use even for those patients with a reduced inspiratory flow rate (e.g. children and elderly people)
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Dispersion system of the Novolizer®
The Novolizer® has a very effective deaggregation system
The cylcone:- Improves separation of particles- Improves flow of particles into thebronchial tree
- Minimises oropharyngeal deposition
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Berner B et al., ASTA Medica Multidose Dry Powder Inhaler. In: Respiratory drug delivery VI. Dalby RN et al. (eds.), Buffalo Grove: Interpharm Press, 1998, 475-477
Conclusion: The Novolizer® exhibits excellent metering performance over the cartridge lifetime independent of temperature and humidity
0.0
2.0
4.0
6.0
8.0
10.0
12.0
14.0
16.0
0 50 100 150 200
Specification limits
Cartridge 1 (25°C/60% sealed)
Dose No.
Met
ered
mas
s [m
g]
Cartridge 2 (25°C/60% not sealed)Cartridge 3 (30°C/70% sealed) Cartridge 4 (30°C/70% not sealed)
Uniformity of metered mass: budesonide 200 µg formulation
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Budesonide 200 µg formulation (nominal mass = 10.0 mg)flow rate corresp. to a pressuredrop of 4 kPa
Conclusion: The Novolizer® exhibits excellent emitting performance. The respirable fraction(FPF) is relatively independent on flow rate
Flow rate (l/min)
10.49.1
24
3428
0
2
4
6
8
10
12
14
16
40 60 80
Emitt
ed m
ass
[mg]
0
10
20
30
40
50
60
70
80
90
100
%B
udes
onid
e ca
lcul
ated
on
the
emitt
ed m
ass
Emitted mass Cascade 3-5 (FPF)
10.5
Emitted mass and fine particle fraction at various flow rates
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0
10
20
30
40
50
60
70
80
90
100
110
120
0 3 6 9 12 18Months
Del
iver
ed d
ose
/fin
e pa
rtic
le d
ose
[in %
of
nom
. dos
e]
0102030405060708090100110120130140150160170180
Emitt
ed m
ass
[in %
of n
om. v
alue
]
Stored at 25°C/60%, 30°C/70%, 40°C/75% - sealed
Conclusion: The Novolizer® ensures stability under all tested climatic conditions
Stability testing: budesonide 400 µg
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Design of the consumer test
Novolizers included in the study– 10
Duration of the study– 100 days
Applications– 2 actuations daily per inhaler (200 actuations per inhaler total)
Investigation parameters– Emitted mass: daily determination (Monday to Friday)– Delivered dose: weekly determination– Fine particle fraction: weekly determination
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Dose No.0 50 100 150 200
%of
the
nom
inal
val
ue
0
20
40
60
80
100
120
Fine particle fraction
Delivered doseEmitted mass
Budesonide 200 µg formulation
Conclusion: The Novolizer® produces stable emitted mass, delivered dose and FPF over the lifetime of the cartridge
The Novolizer® consumer test results
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DesignMicrobiological study: Novolizer® 1-Year in-use test
Placebo controlled
Group 1 (n=3)– Two actuations daily according to instructions for use (n=3)
Group 2 (n=3)– Two actuations daily,– Only 1 inhalation,– One dose remains in the device (n=3)
Group 3 (n=4)– Two actuations daily under worst case conditions
– Inhalation or blowing into the device,– Storage in bathroom, kitchen, outside, ...
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Berner B et al. In: Proceedings of the 46th Annual Congress of APV/APGI, 2000
Conclusion: the microbial status of the cartidges and inhalers afer use is excellent
* Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, Salmonella species,Enterobacteriaceae
Timepoint Total viable Moulds/ Specific[months] aerobic count Yeasts microorg.*
[cfu]
3 < 1 < 1 not detect.
6 < 1 < 1 not detect.
9 < 5 < 5 not detect.
12 < 5 < 5 not detect.
Cartridges
ResultsMicrobiological study: Novolizer® 1-Year in-use test
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Time [sec]
0,2 0,6 1,0
Flow [l/min]
60
30
0,4 0,8
The Novolizer® ensures deposition of drug into the bronchial tree
Unique flow trigger valve- releases powder only after a certain flow ratehas been achieved (I.e. 35 l/min)
Represents a real step forward in DPI technology
Assured delivery = reassured patient
The Novolizer® releases sufficient powder, followed by the desagglomaration of the effective drug form the lactose carrier at a minimum inspiratory flow rate of 35 l/min
The Novolizer® is forgiving of poor technique
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Budesonide200 µg formulation (nominal mass = 10.0 mg)
Flow rate (l/min)
10.49.1
24
3428
0
2
4
6
8
10
12
14
16
40 60 80
Emitt
ed m
ass
[mg]
0102030405060708090100
%B
udes
onid
e ca
lcul
ated
on th
e em
itted
mas
sEmitted mass Cascade 3-5 (FPF)10.5
Novolizer®: relative independence of particle size on flow rate
Consistently emits 90% of the metered dose
Little variation in emitted mass and FPF even when flow rates are halved
90% of particles are
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0.0
2.0
4.0
6.0
8.0
10.0
12.0
14.0
16.0
0 50 100 150 200
Specification limits
Cartridge 1 (25°C/60% sealed)
Dose No.
Met
ered
mas
s [m
g]
Cartridge 2 (25°C/60% not sealed)Cartridge 3 (30°C/70% sealed) Cartridge 4 (30°C/70% not sealed)
Novolizer®: influence of temperature and humidity
Conclusion: Uniformity of emitted mass of drug from the Novolizer® is not influenced by varying conditions temperature and humidity
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Low intrinsic resistance
Lower airflow resistance to Turbuhaler®
- Assuming a flow rate of 60 L/min, resistance is two times higher with Turbuhaler®
Easy for patients to use
Suitable for most patients even those with reduced inspiratory flow rate
May improve patient compliance
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Cost effectiveness
The Novolizer® is robust, can be used every day, twice a day for up to one year before it needs to be replaced
The Novolizer® is refillable
The most expensive inhaler is one that patients cannot use correctly- Novolizer® = assured drug delivery
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Improved patient compliance
The multiple control system positively reinforces to the patient that medication has been taken
The dose counter works indirectly only after a correct inhalation- Positive reinforcement to patients that drug has been taken- Doctor can count how many doses have been taken
The Novolizer® is easy to use- It has a low intrinsic resistance- Patients are guided through the inhalation procedure by the triple control system
Patients are extremely satisfied with the Novolizer® (Kunkel and Chuchalin,2001)
The Novolizer® is pocket-sized and easy to carry
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Award: golden safety material in medicine
Acknowledges the unique position of the Novolizer®
Confirms that the Novolizer®
represents a new standard in inhalation devices
Supports introduction of new standard in safe inhalation technology
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Eur Respir J 2000; 16: 178-183
Newman et al, 2000 - deposition
MethodGamma scintigraphic evaluation14 healthy volunteers (males/females)
Target parameterIn vivo deposition of a dry powder formulation from the Novolizer® at various flow rates versus the Turbuhaler®
Clinical Aspects
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Lung
Oropharynx
Device
Exhaled Air
32.1
57.0
9.5
0.8
(9.4 - 41.0)
(45.1 - 81.7)
(5.5 - 23.2)
(0.2 - 1.8)
25.0
61.6
15.6
0.6
(12.1 - 37.4)
(42.2 - 77.6)
(1.2 - 20.0)
(0.2 - 3.0)
19.9
60.9
17.3
0.2
(8.8 - 26.6)
(49.5 - 68.3)
(11.8 - 43.0)
(0 - 0.9)
21.4
71.9
11.6
0.2
(4.7 - 29.2)
(54.8 - 80.0)
(5.3 - 22.0)
(0 - 0.7)
Regimen% of metered dose; medians (ranges)
HeadlineHeadline
Novolizer®90L/min
Novolizer®60L/min
Novolizer®45L/min
Turbuhaler®60L/min
Eur Respir J 2000; 16: 178-183
Newman et al, 2000 - fractionation of dose (n=13) vs Turbuhaler®
Clinical Aspects
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Novolizer®90L/min
0
5
10
15
20
25
30
35
40
Lung
dep
ositi
on[%
met
ered
dos
e]
Novolizer®60L/min
Novolizer®45L/min
Turbuhaler®60L/min
Newman et al, 2000 - lung deposition vs Turbuhaler®
At least as much deposition when used at similar rates
When used optimally the Novolizer® deposits more in lungs
Turbuhaler® deposits more drug in the mouth
Clinical Aspects
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Conclusion:
Novolizer®90L/min
Novolizer®60 L/min
Novolizer®45 L/min
Turbuhaler®60 L/min
Superiority of the Novolizer vs Turbuhaler® due to better drug deposition with less airflow resistance
Novolizer® : Lung deposition
Clinical Aspects
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Turbuhaler® = uncertainty
Novolizer®
Precise dose delivery (FPF 30%)
Flow trigger valve
Guarantees sufficient drug deposited in lungs
Significantly better lung deposition
Turbuhaler®
High dose variation
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Equivalence study outline
Design– Randomized, open, multicenter parallel group study.
Centers– 11 centers
Patients– 315 asthmatics (224 female, 91 male; 18-75 years of age)
Inclusion criteria– Persistent mild-to-moderate asthma, FEV1: 60-90% predicted;
>15% reversibility; patients with regular pretreatment except steroids and patients on steroids
Treatment– 2 weeks run-in phase followed by 400 µg/d BUD (200 µg every 12 hours) delivered by either the
Novolizer® (n=153) or Turbuhaler® (n=158)
Kremer HJ et al. In: Scheuch G et al. Aerosole in der Inhalationsth. IV. Dusin: München, 2001; Chuchalin et al., Respiration 2002; 69: 502-508
Equivalence Study Budesonide 200 Novolizer® vs Pulmicort® Turbuhaler®
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Target parameters
Primary efficacy parameter– FEV1 after 12 weeks of treatment
Secondary efficacy parameters– PEFR morning and evening, – Circad. PEFR variability, – Asthma symptoms, nocturnal awakening, – Use of ß2-agonists– PC20FEV1 after histamine provocation, – Assessment of efficacy
Safety– AEs (incidence, severity)– Cough and paradoxical bronchospasm, – Laboratory, ECG, RR, HF, opthalmological screening
Kremer HJ et al. In: Scheuch G et al. Aerosole in der Inhalationsth. IV. Dusin: München, 2001; Chuchalin et al., Respiration 2002; 69: 502-508
Clinical Aspects
Equivalence Study Budesonide 200 Novolizer® vs Pulmicort® Turbuhaler®
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Efficacy results
Primary target parameters– Mean FEV1 baseline values and improvement in FEV1 at the end of the study were comparable for
the Novolizer® and Turbuhaler®
Secondary target parameters– No clinically relevant or statistically significant differences between the groups were observef for:
PEFR (morning and evening), asthma symptoms, nocturnal awakening or rescue medication use– Histamine provocation test: essential differences between patients with or without pretreatment
with steroids, however, no significant differences between the Novolizer® and the Turbuhaler®groups.
– Global assessment of efficacy: investigators considered the efficacy of treatment to be ‚good‘ or‚very good‘ in 87% of patients in the Novolizer® group compared to 79% of patients in the Turbuhaler® group.
When delivering budesonide, the Novolizer® is therapeutically equivalent to the Turbuhaler® with respect to efficacy in mild-to-moderate asthmatics
Kremer HJ et al. In: Scheuch G et al. Aerosole in der Inhalationsth. IV. Dusin: München, 2001; Chuchalin et al., Respiration 2002; 69: 502-508
Clinical Aspects
Equivalence Study Budesonide 200 Novolizer® vs Pulmicort® Turbuhaler®
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Safety and tolerability results
Paradoxical bronchospasmFEV1 decrease within 15 minutes after inhalation
– Novolizer® group (4)– Turbuhaler® group (6)
Incidence of adverse events– comparable in both groups
Blood pressure, heart rate, ECG, opthalmological examinations and laboratory values– No signs of clinically relevant adverse reactions or differences between groups
When deliverying budesonide, the Novolizer® is therapeutically equivlaent to the Turbuhaler®
with respect to safety and tolerability in mild-to-moderate asthmatics
Kremer HJ et al. In: Scheuch G et al. Aerosole in der Inhalationsth. IV. Dusin: München, 2001; Chuchalin et al., Respiration 2002; 69: 502-508
Clinical Aspects
Equivalence Study Budesonide 200 Novolizer® vs Pulmicort® Turbuhaler®
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250
300
350
400
450
Week
PEFR
[l/m
in]
Novolizer morning Turbuhaler morning
Novolizer evening Turbuhaler evening
1-2Baseline 3-4 5-6 7-8 9-10 11-12
Results (1)
Kremer HJ et al. In: Scheuch G et al. Aerosole in der Inhalationsth. IV. Dusin: München, 2001; Chuchalin et al., Respiration 2002; 69: 502-508
Clinical Aspects
Equivalence Study Budesonide 200 Novolizer® vs Pulmicort® Turbuhaler®
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0
1
2
3
4
Salb
utam
ol p
uffs
Novolizer Turbuhaler
Week1-2Baseline 3-4 5-6 7-8 9-10 11-12
Results (2)
Kremer HJ et al. In: Scheuch G et al. Aerosole in der Inhalationsth. IV. Dusin: München, 2001; Chuchalin et al., Respiration 2002; 69: 502-508
Equivalence Study Budesonide 200 Novolizer® vs Pulmicort® Turbuhaler®
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1,5
2
2,5
3
3,5
0 4 8 12Week
FEV1
[l]
Novolizer Turbuhaler0
0,1
0,2
0,3
0,4
0,5
0 4 8 12Week
FEV1
chan
ges
vs
basi
slin
e va
lues
[l]
Novolizer Turbuhaler
250
300
350
400
450
Base
line
1-2 3-4 5-6 7-8 9-10
11-12
Week
PEFR
[l/m
in]
Novolizer morning Turbuhaler morningNovolizer evening Turbuhaler evening
0
1
2
3
4
Base
line
1-2 3-4 5-6 7-8 9-10
11-12
Week
Salb
utam
ol p
uffs
Novolizer Turbuhaler
Course of FEV1 FEV1 changes
Course of PEFR Course of Salbutamol consumption
(morning and evening)
Results (3)
Kremer HJ et al. In: Scheuch G et al. Aerosole in der Inhalationsth. IV. Dusin: München, 2001; Chuchalin et al., Respiration 2002; 69: 502-508
Equivalence Study Budesonide 200 Novolizer® vs Pulmicort® Turbuhaler®
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Features
Drug deposition in the lungs even at low flow rates
Easy handling
Suction power required for inhalation
Multiple feedback mechanisms
Correct inhalation manoeuvre feedback
Accurate dosage counter
Display of readiness to inhale (green field)
Refillable
Novolizer®
low -to-moderate
Turbuhaler®
-
( )
high
-
-
-
-
-
Data on file
Novopulmon® 200 Novolizer®
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Pressure and flow comparison (1): Novolizer® vs Turbuhaler ®
Comparison of patient technique and inspiratory characteristics of the Novolizer® and the Turbuhaler®
60 patients with mild asthma
Patients had never used a dry powder device previously
Inhalation of placebo at least twice by Novolizer® or Turbuhaler®, respectively
Cegla, ERS 2002, Stockholm
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Flow rate not reached
Novolizer®(n)
Turbuhaler®(n)
30 l/min 0 3
60 l/min 8 25
N = 60
Cegla, ERS 2002, Stockholm
Pressure and flow comparison (2): Novolizer ® vs Turbuhaler ®
Conclusion: More patients were unable to generate a peak inspiratory flow of either 30 l/min or 60 L/min through the Turbuhaler® compared to the Novolizer®
Novolizer® vs Turbuhaler® (Prof. Cegla, Dernbach)
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0.375
1.336
0.770
1.450
5.071
0.569
0.905
0.333
1.494
28.453
Time to max. pressure (s)
Peak flow (l/s)
Time (s) flow >60 l/min
Time (s) flow >30 l/min
Resistance (cm H2O.s/l)
Parameter Novolizer®(n)
Turbuhaler®(n)
Cegla, ERS 2002, Stockholm
Pressure and flow comparison (3): Novolizer ® vs Turbuhaler ®
Conclusion: Overall, the Novolizer® has a better inhalation performance to the Turbuhaler®
Novolizer® vs Turbuhaler® (Prof. Cegla, Dernbach)
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Can children use the Novolizer®?
Aim: to determine if children aged between 4 and 11 years withstable bronchial asthma are ableto generate sufficient peak inspiratory flow (PIF) through the Novolizer®?
136 children. Multicenter, randomised, open label study design
Parameters assessed- FEV1- PIF withouth the Novolizer®
- PIF with the Novolizer® (PIF-N)
Leupold et al., ERS 2002, Stockholm
PIF Values in Children suffering from asthma (Prof. Leupold, Dresden)
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Leupold et al., ERS 2002, Stockholm
Results: can children use the Novolizer®?
Without the Novolizer® children could generate a PIFof 147 ± 46 L/min (mean ± SD)
With the Novolizer children could generate a PIFof 76 ± 19 L/min (mean ± SD)
Both PIF and PIF-N showed a linear dependence on age (older children could generate higher values)
The threshold value for activating the Novolizer® (i.e. 30 L/min) was exceeded by >40 l/min
The high PIF-N generated by children is due to the low-to-medium resistance of the Novolizer®
Conclusion: the Novolizer® is suitable for inhalation therapy in asthmatic children
PIF Values in Children suffering from asthma (Prof. Leupold, Dresden)
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40
60
76
86 83
0
10
20
30
40
50
60
70
80
90
100
Triggerthreshold
4 - 5years
6 - 7years
8 - 9years
10 - 11years
PIV-
N (l
/min
)
Conclusion: The Novolizer® is suitable for inhalation therapy in children aged 4-11 years with stable asthma
Leupold et al., Clinical Evaluation of the Peak Inspiratory Flow Generated by Asthmatic Children Through the Novolizer, Eur Respir J 2002; 20 Suppl 38: 430s
Trigger threshold of the Novolizer® and PIF-N by age inchildren with stable asthma
PIF Values in Children suffering from asthma (Prof. Leupold, Dresden)
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Study Outline
Aim: to investigate the maximum inspiratory flow which children with stable asthma can achieve during inspiration through the Novolizer® compared to the Turbuhaler®
48 children aged between 4 - 11 years with stable asthma
Parameters assessed- FEV1, - PIF (without device)- PIF-N (Novolizer®)- PIF-T (Turbuhaler®)
Conclusion: The trigger threshold for activating the Novolizer® (i.e. 30 L/min) was easily exceeded by children aged between 4-11 years with stable asthma. The PIF generated through the Novolizer® was significantly higher than the PIF generated through the Turbuhaler® for allage groups studied
van Berg, et al, Eur. Respir. J. 2003
Novolizer® vs. Turbuhaler®: Clinical Study of Maximum Inspiratory Flow in Children
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Age [y] N PIF[l/min]
PIF-N PIF-T PIF-N/T-ratio
4-5 2 78.9 ± 14.0 72.3 ± 5.5 57.9 ± 11.5 1.26 ± 0.15
6-7 16 150.2 ± 46.7 82.6 ± 16.7 62.3 ± 13.1 1.33 ± 0.10
8-9 14 186.3 ± 69.5 100.6 ± 16.4 74.7 ± 10.7 1.36 ± 0.20
10-11 16 217.8 ± 59.0 98.4 ± 18.8 71.7 ± 12.2 1.37 ± 0.14
All 48 180.3 ± 66.2 92.7 ± 18.9 68.9 ± 13.0 1.35 ± 0.15
PIF-N was significantly higher than PIF-T in all age groups (p
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0
20
40
60
80
100
120
Triggerthreshold
all patients
6 to 7years
8 to 9years
10 to 11years
L/m
inPIF-T PIF-N
PIF-N and PIF-T for different age groups
New Clinical Data: Novolizer and Ease of Use in Severe Asthma
Inhalation Inspiration Innovationvan Berg, et al, Eur. Respir. J. 2003
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Post Marketing Surveillance (PMS) in Patients with Bronchial Asthma
Novolizer® budesoinde 200 µg
Scope: 3057 patients in 963 centers
Collection of data on clinical efficacy, tolerability and patient acceptance of the device
Patients with or without inhaled asthma pretreatment
Duration of observation per patient: 4 weeks
Parameters assessed– Lung function (PEFR, FEV1)– Symptoms (cough, rhonchus, nocturnal dyspnea, dyspnea on exertion)– Satisfaction with control functions– Assessment of patient compliance by the treating physician
Moeller et al, Drug Research 53, No 8, 562-567, 2003
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Post Marketing Surveillance (PMS) in Patients with Bronchial Asthma
Novolizer® budesonide 200µg: results (1)
Parameters of lung function– Median PEF increased from 5 Ll/s to 6.3 L/s– Median FEV1 increased from 2250 ml to 2700 ml
Symptoms improved in most patients- Median symptom score fell from 8 before therapy to 2 after therapy
The proportion of patients complaining of each assessed symptom decreased– Cough: 93.0% at baseline to 56.5% post-treatment– Wheezing: 87.9% at baseline to 37.9% post-treatment– Diurnal dyspnea: 87.2% at baseline to 40.3% post-treatment– Nocturnal dyspnea: 80.5% at baseline to 37.0% post-treatment– Dyspnea on exertion: 97.3% at baseline to 75.2% post-treatment
Moeller et al, Drug Research 53, No 8, 562-567, 2003
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Post Marketing Surveillance (PMS) in Patients with Bronchial Asthma
Novolizer® budesonide 200µg: results (2)
Satisfaction with multiple inhalation control features (all patients)– 62% of the patients: excellent– 37% of the patients: good
Satisfaction with multiple inhalation control features(patients pretreated with other inhalation system before)
– 93% of the patients: better / much better– 96% of the patients reported better compliance due to the control mechanisms
Assessment by the treating physicians– Improvement of compliance due to control mechanisms in 98% of the patients– Better control of compliance was rated by 95% of the physicians
Moeller et al, Drug Research 53, No 8, 562-567, 2003
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Post Marketing Surveillance (PMS) in Patients with Bronchial Asthma
Novolizer® budesonide 200µg: results (3)
Control of drug intake by different control mechanisms was confirmed by 97% of patients– 88%: optical control mechanism– 81%: acoustic control mechanism– 46%: taste control mechanism
Dose counter control– 92% of the patients were satisfied with the counter– 81% of the patients assessed the dosage stop as „good“– 79% of the patients were pretreated with another inhalation system, (Diskus® and Turbuhaler®)-
Evaluation will follow
Novolizer® budesonide 200µg proved to be clinically effective with high acceptance of thecontrol functions and improved compliance
Moeller et al, Drug Research 53, No 8, 562-567, 2003
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Novolizer®: Clinical Aspects
Commonly prescribed DPIs vs Novolizer®
Easy, reliable & convenient to use
Easy to teach, learn & remember how to use correctly
Accurate & consistent dose delivery
High deposition rate
Patient feedback of dose taken
Accurate dose counter
Delivers a range of molecules
CFC-free & conveniently carried
Certainty given to patient and doctor
Novolizer´sfeatures TH Diskus Aerolizer
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Novolizer®: Clinical Aspects
Gina Guidelines 2002
Novolizer therapies cover all levels of asthma severity
Level of Severity (US est. Diagnosed cases* (16M) )
Daily Medications Quick Relief &Prevention **
Intermittent Asthma (7M) none necessary
Mild Persistent Asthma (3M) glucocorticosteroid
Moderate Persistent Asthmaglucocorticosteroidlong-acting ß2-agonist
Severe Persistent Asthmaglucocorticosteroid
+ - sustained-release theophylline- leukotriene modifier - long-acting oral ß2-agonist- oral glucocorticosteroid
one or more if neededalso recommended for prevention of exercise induced asthma* Decision Resources, NHIS, ALA Reports
(3M)
(3M)long-acting ß2-agonist
**
short-actingß2-agonist
short-actingß2-agonist
short-actingß2-agonist
short-actingß2-agonist
+