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

Asthma control worsens as the number of

mistakes in inhaler technique increases
Asthma instability scores (AIS) units

6
p<0.0001

5
4
3

More incorrect the technique, more

uncontrolled is the disease

2
1
0
Number
of errors

>7

Eur Resp J 2002; 19: 246-251

Change in FEV1
%

30

Good technique
Bad technique

20

10
15

30

60

90 Min

Improvement in lung function does depend on the technique

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

Hence
Poor inhalation technique

Reduced drug deposition

Poorer asthma control

Inhaled Drug
Delivery System

Metered Dose
Inhaler (MDI)

Add on devices
(spacer + mask)

Dry Powder Inhaler

(DPI)

Nebulizer

Breath 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 pMDI
and 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 in
acute asthma attacks

Who should use spacers

Patients with co-ordination problems
Children and the elderly
Those who are prescribed high dose inhaled
steroids (more than 1000 mcg/day)
Patients with acute asthma requiring high-dose
bronchodilators, as a substitute to nebulizers
Those who are prescribed anti-cholinergic drugs
(to avoid the spray particles from reaching the
eyes)

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

Drawbacks of the spacer

Bulky and inconvenient to

carry
More expensive than pMDI
alone
Need to be washed regularly

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.

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
Unit dose

Rotahaler
Revolizer
Lupihaler
Reddyhaler
Myhaler
Turbospin
Machaler
Adhaler
Aphaler
Octahaler

Multi dose

Discrete

Reservoir

Multihaler
Accuhaler
Sunhaler

Turbohaler
Novolizer

REVOLIZER

MULTIHALER

ROTAHALER

Rotahaler - Just 3 simple stepsInsert, Rotate and Inhale

Revolizer - Just 3 simple stepsInsert, shut and Inhale

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

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.

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

1. Respir Med 2008; 102: 593604

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

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

There is a need for a easy to use device

BAIs
Breath Actuated Inhalers

Bunching together the benefits of MDI and DPI

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
Mouthpiece
Mouthpiece
Cover

Trigger
Assembly
Slide

How does the Autohaler work?

Advantages
Simple to learn, use and teach

Disadvantages
Patients has to inhale to
trigger the device
No need to coordinate actuation
Patients need to be
and inhalation
instructed to inhale slowly.
Works effectively at low inspiratory Patients sometimes stop
flow rate of 20-30 l/min
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 through
the autohaler
The patient should not stop breathing in on hearing
the click sound.

Possible errors/difficulties in the use

of the Autohaler
Device 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

Lung Deposition (%)
22.80%
20.80%

Patients using Autohaler achieved 3 times more lung

deposition as compared to patients with poor pMDI
technique.
7.20%

Patients using pMDI with poor technique

Patients using pMDI with good technique

Patients using Autohaler

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
Inhaler preference score
140

120

100

91% of patients showed a good technique with the breathactuated devices.

80

60

40

20

0
Breath-Actuated
Inhaler

Autohaler

Multi-dose DPI

Multi-dose DPI

pMDI

Reservoir DPI

pMDI+spacer

Respir Med 2000; 94: 496-500.

Seroflo Autohaler - High patient preference

80%

75%

70%

60%
50%

40%
30%

25%

20%
10%

0%
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)

Children
11 were < 6with
years acute wheezy condition could
Autohaler 99% of times
Results actuate
:
Rotahaler was actuated 74/100 times
Autohaler was actuated in 99/100 times

Arch Dis Child 1993;68:477-80

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

st
1

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