Key factor for good disease control

DRUG or DEVICEorPATIENT

Or

Is it all of them ?

Uncontrolled asthma: still a concern despite advanced pharmacotherapy and guidelines

Uncontrolled asthma is highly prevalent (55%)in patients using standard asthma medications1

62% uncontrolled asthmatics in India2

1. J Allergy Clin Immunol 2007;119:1454-61

2. E-communication: E-221, ERS 2008

According to Asia-Pacific AIM Survey

100% asthma patients in India are either

uncontrolled or party controlled

Respirology 2013; 18(6): 957-67

Reasons for poor asthma control

Under-diagnosis

Non-adherence with medication

Sub-optimal levels of ICS

Choice of inhaler device

Design of the device and its characteristics

Technique of usage

Respir Med 2003; 97: 12- 19

01

2

3

4

5

6

Numberof errors

0 1 2 3 4 5 6 > 7

Asth

ma

in

sta

bili

ty s

co

res (

AIS

)u

nits

More incorrect the technique, more

uncontrolled is the disease

Eur Resp J 2002; 19: 246-251

p

10

20

30

%

15 30 60 90 Min

Change in FEV1

Thorax. 1991; 46(10):712-716

Good technique

Bad technique

Improvement in lung function does depend on the technique

Poor inhalation technique

Reduced drug deposition

Poorer asthma control

Hence

Inhaled Drug Delivery System

Metered Dose Inhaler (MDI)

Add on devices (spacer + mask)

Dry Powder Inhaler (DPI)

NebulizerBreath Actuated Metered dose inhaler (BAI)

pMDIs

(Pressurized Metered Dose Inhalers)

Most widely used delivery system

Small and convenient

Quick to use

Reproducible dosing

Independent of inspiratory airflow

Key parts of the pMDI

pMDIs with dose counter

pMDIs: Not so good

Nearly 80% of the patients can not use their pMDIs correctly.

Highly technique dependent

Co-ordination between actuation and inhalation

Requires slow and deep inhalation

High velocity of drug spray increased oropharyngeal deposition

(Increased local side effects)

Cold freon effect

Common Patient Errors in the Use of pMDIs

Patients using pMDIs make more errors than users of any other types of inhalers

The most frequently observed errors with MDIs are:

Lack of synchronization of hand actuation and inhalation.

Failure to breathe out before actuation

Failure to breathe in slowly and deeply through the pMDI

Failure to hold breath for few seconds after inhalation

Respir Care 2008;53(6):699 723.

Spacer is used to overcome the limitations of pMDI

Advantages of Spacer Devices

Overcomes the co-ordination problem of pMDIand makes pMDI easier to use.

Reducing oropharyngeal deposition

Decrease in local side effects

Decrease in systemic side effects

Improving pulmonary deposition

Can be used as an alternative to nebulisers inacute asthma attacks

Who should use spacers

Patients with co-ordination problems

Children and the elderly

Those who are prescribed high dose inhaledsteroids (more than 1000 mcg/day)

Patients with acute asthma requiring high-dosebronchodilators, as a substitute to nebulizers

Those who are prescribed anti-cholinergic drugs(to avoid the spray particles from reaching theeyes)

Zerostat VT

Non static CTP* material

Transparent

Diamond shaped

280 ml Volume

One way, low resistant, non static valve.

Half life (T) is approx 60 sec.

*CTP Customized Thermoplastic Polymer

Common patient errors in

the use of pMDI+spacer

Failure to shake or inadequate shaking of the canister

Incorrect assembly of device

Failure to breathe out before actuation

Failure to breathe in slowly through spacer

Failure to hold breath for few seconds after inhalation

Delay between actuation and inhalation

Firing multiple puffs into device

Respir Care 2008;53(6):699 723.

Drawbacks of the spacer

Bulky and inconvenient to carry

More expensive than pMDIalone

Need to be washed regularly

DPIs

(Dry Powder Inhalers)

Breath activated device

Most widely accepted therapy

Simple to use and teach

Solves co-ordination problem

Micronized drug with carrier lactose

Easy to carry

Compact, Portable

Classification of DPIs

DiscreteRotahalerRevolizer

Lupihaler

Reddyhaler

Myhaler

Turbospin

Machaler

Adhaler

Aphaler

Octahaler

Multihaler

Accuhaler

Sunhaler

Turbohaler

Novolizer

Unit dose

Reservoir

Multi dose

REVOLIZER ROTAHALERMULTIHALER

Transparency Visual feedback Turbulence Audio feedback Lactose as carrier Taste feedback Indigenously developed in India by Cipla Optimal lung deposition Consistent dose delivery across various inspiratory flow

rates

Backed by research studies One device for all medication

Rotahaler - Just 3 simple steps-

Insert, Rotate and InhaleRevolizer - Just 3 simple steps-

Insert, shut and Inhale

DPIs: Not so good

Inspiratory flow rate dependent device, so unsuitable in:

Older patients

Acute severe attacks

Young children

Not for all age groups

Potentially vulnerable to humidity and moisture

Dose lost if patient exhales into the device

Potential for dose uniformity problems

Common patient errors in the use of DPIs

The most frequently observed errors with DPIs are:

failure to exhale before inhaling

failure to forcefully and deeply inhale through the device

failure to hold breath after inhalation.

Respir Med 2008; 102: 593604

Respir Care 2008;53(6):699 723.

1. Respir Med 2008; 102: 593604

2. Respir Care 2006; 51(2): 158-172

Many inhalers, both pMDIs and DPIs, are complicated to use, some

requiring up to eight steps for a correctly usage1

28-68% of patients cannot use pMDIs or DPIs correctly2

85% of patients do not use their inhalers correctly2

Significant number of patients (24.5%) cannot use their

devices correctly even after instruction

Respiratory Medicine (2008) 102: 593604

Clinical consequences due to incorrect

use of inhalers

Reduced amount of drug in airways

Decreased effect

Lack of confidence in therapy

Reduced compliance

Poor control of disease

Decreased QoL and higher cost

JACI 1995;96:278-83

BAIsBreath Actuated Inhalers

Bunching together the benefits of MDI and DPI

There is a need for a easy to use device

BAIs

(Breath Actuated Inhalers)

BAIs sense the patients inhalation through the actuator and actuate

the inhaler automatically in synchrony

These devices emit a dose when a sufficient inspiratory flow

(20-30 L/min) is achieved*.

No need to co-ordinate between actuation and inhalation*.

Easy to use, teach and learn.

Example : Autohaler*Thorax 1991; 46: 712-716

The Autohaler(Breath actuated pressurized metered dose inhaler)

BAI (breath actuated inhaler)

Parts of the Autohaler

Lever

Top Cap

Sleeve

Body

Aerosol

Valve

Trigger

AssemblyMouthpiece

Mouthpiece

Cover Slide

How does the Autohaler work?

Advantages Disadvantages

Simple to learn, use and teach Patients has to inhale to trigger the device

No need to coordinate actuation and inhalation

Patients need to be instructed to inhale slowly.

Works effectively at low inspiratoryflow rate of 20-30 l/min

Patients sometimes stop inhaling once actuation

occurs

Releases the drug at a low velocity of 20 m/sec

Indicated for all age groups -adults, elderly and children

Spacer or valved holding chamber is not required

How to inhale through the Autohaler

The patient should inhale slowly and deeply throughthe autohaler

The patient should not stop breathing in on hearingthe click sound.

Possible errors/difficulties in the use

of the AutohalerDevice related

Difficulty in removing the

cap

Failure to lift the lever

Holding the Autohaler

upside down

Not replacing the cap

Device unrelated

Failure to exhale completely

before breathing in

Failure to breathe in slowly

and deeply

Failure to hold breath for 10

seconds

Breathing in through the

nose

Research studies on Autohaler

Autohaler Vs pMDIs

18 patients with asthma

Patients inhaled 100 g salbutamol through

pMDI (own technique)

pMDI (taught technique)

Autohaler

Thorax. 1991; 46(10):712-716

Improved lung deposition

7.20%

22.80%

20.80%

Patients using pMDI with poor technique Patients using pMDI with good technique Patients using Autohaler

Lung Deposition (%)

Patients using Autohaler achieved 3 times more lung

deposition as compared to patients with poor pMDI

technique.

Thorax. 1991; 46(10):712-716

Patients using pMDI found Autohaler

much easier to use

98% of experienced pMDI users, rated Autohaler as easy to use

88% patients found it was easy to breathe in a puff through Autohaler

76% thought the Autohaler was much easier to use or easier to use

83% patients rated the overall use of Autohaler as excellent or good

Journal of Asthma 1993; 30(6): 439-443

Patients prefer autohaler over other

devices

0

20

40

60

80

100

120

140

Breath-ActuatedInhaler

Autohaler Multi-dose DPI Multi-dose DPI pMDI Reservoir DPI pMDI+spacer

Inhaler preference score

Respir Med 2000; 94: 496-500.

91% of patients showed a good technique with the breath-

actuated devices.

Seroflo Autohaler - High patient preference

75%

25%

0%

10%

20%

30%

40%

50%

60%

70%

80%

Autohaler pMDI

Autohaler showed a much higher patient preference as compared

to the conventional pMDI.

P703, presented at European Respiratory Society (ERS) conference, 2013

Use of Autohaler in

difficult situations

Autohaler in acute wheezy

children Comparison of Autohaler and Rotahaler in 51 hospitalised

children with acute exacerbations

4-13 years (mean:9 years)

11 were < 6 years

Results :

Rotahaler was actuated 74/100 times

Autohaler was actuated in 99/100 times

Arch Dis Child 1993;68:477-80

Children with acute wheezy condition could

actuate Autohaler 99% of times

Autohaler in patients with severe

airways obstruction

26 patients with severe airway obstruction (FEV1 < 1 liter)

Preference for Autohaler vs conventional inhaler was noted

24 out of 26 could trigger autohaler easily

Adults with severe airflow obstruction could

trigger Autohaler 92% of times

Br Med J 1971; 2(5762): 652-653

Indias 1st BAI - Autohaler

No co-ordination required easy to use1

Simple to learn and use

Works effectively at low inspiratory flow rate of 20-30 l/min1

Releases the drug at a low velocity of 20 m/sec2

200 doses ensures long term management

As effective as pMDI + spacer3

Indicated for all age groups - adults, elderly and children*

1. Thorax 1991; 46: 712-716

2. Data on file, Cipla ltd.

3. Chest 2000; 117: 1319 1323

*4 years and above (Seroflo) and 6 years and above (Foracort)

Only companies to have Autohaler

3M

Teva

Cipla: Worlds 1st ICS/LABA in the Autohaler

Autohaler

Just breathe in& well deliver