GINA assessment of asthma control

From the Global Strategy for Asthma Management and Prevention 2016,
© Global Initiative for Asthma (GINA) all rights reserved. Available from
http://www.ginasthma.org
 Preferred choice of pharmacotherapy: 6-11 years, adolescents,
adult
GINA 2016

Disease severity
Severe
asthma
Moderate
asthma Step 5
Mild asthma Step 4 Refer for
add-on
PREFERRED Step 3 Medium- treatment
CONTROLLER Step 1 Step 2
dose e.g.
CHOICE Low-dose ICS/LABA tio*, oma,
Low-dose ICS ICS/LABA mepo

Med/high-dose Add tio*

Other Consider ICS; low-dose High-dose Add low-
controller low-dose LTRA
ICS+LTRA ICS+LTRA dose OCS
options ICS Low-dose theoph (or + theoph) (or + theoph)
As-needed SABA or low dose
RELIEVER As-needed SABA
ICS/formoterol

*Tiotropium by mist inhaler is an add-on treatment for patients with a history of exacerbations.
GINA, Global Initiative for Asthma; ICS, inhaled corticosteroid; LABA, long-acting beta2-agonist; LTRA, leukotriene receptor antagonist; mepo,
mepolizumab; OCS, oral corticosteroid; oma, omalizumab; SABA, short-acting beta2-agonist; theoph, theophylline; tio, tiotropium.

Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2016. Available from: https://www.ginasthma.org. 2
© 2016 Global Initiative for Asthma, all rights reserved. Use is by express license from the owner
Asthma control: fixed vs variable
 Managing the challenge of residual asthma
symptoms in adults using ICS/LABA has been
managed in two ways:1
– Increase maintenance dose of fixed-dose
combination
– Use combination as single maintenance and
reliever therapy (SMART)2
 SMART suggested to offer convenience and better
improvements in outcomes with lower ICS dosing3
 Does evidence support the use of this strategy?

1. Bousquet J, et al. Respir Med 2007. 2. Chapman KR, et al. Thorax 2010.
3. Humbert M, et al. Allergy 2008.
 Reliever used in SMART study 1

Asthma control by SMART study

(formoterol/budesonide as reliever and controller)

Rabe Scicchi O’Bryne Rabe Vogelme Kuna Bousquet Weighted

et a 2 tano et et al 4 et al 5 ier et al 6 et al 7 et al8 Averages
al 3
N 354 947 925 1107 1067 1052 1151
(SMART arm)
Length of study 6 12 12 12 12 6 6 bulan N/A
bulan bulan bulan bulan bulan bulan
Usage of
reliever 1.04 0.9 1.01 1.02 0.59† 1.02 0.95 0.92
inhalation /day

Usage formoterol/budesonide as reliever & controller

showing that patient add almost one puff every day
1.K. Czarnecka and K. Chapman. ‘The clinical impact of single inhaler therapy in asthma’ Clin Exp Allergy 2012. 2. Rabe KF et al. Budesonide/Formoterol in a Single Inhaler for Maintenance and
Relief in Mild-to-Moderate Asthma. A Randomised, Double-Blind Trial. CHEST 2006; 129: 246 - 256.3. Scicchitano R. et al. Efficacy and safety of budesonide/formoterol single inhaler therapy
versus a higher dose of budesonide in moderate to severe asthma. Curr Med Res Opin 2004; 20: 1403-18.4. O’Byrne PM et al. Budesonide/formoterol combination therapy as both maintenance
and reliever medication in asthma.5. Rabe KF et al. Effect of budesonide in combination with formoterol for reliver therapy in asthma exacerbations: a randomised controlled, double-blind study.
Lancet 2006; 368: 744 - 753.6. Vogelmeier C et al. Budesonide/formoterol maintenance And reliever therapy: an effective asthma treatment option?Eur Respir J 2005; 26: 819-28.
7. Kuna et al. Effect of budesonide/formoterol maintenance and reliever therapy on asthma exacerbations. Int J Clin Pract 2007; 61:725-36.8. Bousquet et al. Budesonide/formoterol for
maintenance and relief in uncontrolled asthma vs. high-dose salmeterol/fluticasone. Respir Med 2007; 101: 2437-46.
 TOTAL CONTROL WELL-CONTROL
(GOAL )1 (GINA) 2
Night awakening Use of reliever ≤2x per
No Daily symptoms
due to asthma almost every week

Exacerbation No day
Activity limitation
No
due to asthma
Reliever What it is
No
usage mean? ≤2x per
Reliever usage
week
Emergency visit No

morning PEF  Night awakening

No
normal Asthma control due to asthma
80%
Drug related
cannot be
No achieved using
adverse event
Form/Bud as
reliever &
controller
1. Bateman ED et al. Am J Respir Crit Care Med 2004; 170(8):836–844.
2. Global Strategy for Asthma Management and Prevention, GINA 2016 page 29. Downloaded from www.ginasthma.org
How many patients can
achieved asthma control
defined by GINA ?
Achieving GINA guideline-defined control
by fixed dose Salm/FP (GOAL study)
100

80 78%* 75%**
70%

60% 62%**
60

47%

40
CONTROLLED
% of patients

20

Well Well Well Well Well Well

Controlled Controlled Controlled Controlled Controlled Controlled
0
Moderate dose ICS (S3)
Steroid naïve (S1) Low dose ICS (S2)

*p=0.003 Fp
**p<0.001 Bateman et al ARJCCM 2004
Sal/Fp
Level of patients’ asthma control that
treated by SMART concept
Studies analyzed:
17.1%
44.2%

37.8%

n = 5,246

Controlled Partly Controlled

Uncontrolled

Only 17% of asthma patients can be controlled by Form/Bud SMART !

Czarnecka & Chapman. Clinical & Experimental Allergy, 1–8, 2012

REGULAR DOSING VS. VARIABLE DOSING:
BIOPSY INFLAMMATORY CELLS

120 +
100
80
60
% 40
change 20 **
from
0
baseline +
-20 Total Cells Mast Cells** CD4+ Eosinophils
-40
-60
Regular Dosing Variable Dosing

n = 127
+ p < 0.001
** p = 0.0012

Pavord et al J Allergy Clin Immunol 2009;123:1083-1089

 Asthma control: fixed vs variable:
Conclusion
 Based on Chapman review, the reliever used in
SMART study show that the patient use
additional almost one puff per day1

 GINA defined asthma control achieved by:

– 71% fixed dose Salm/FP2
– 17% adjustable dose For/Bud1

1. Chapman KR et al. Thorax 2010

2. Bateman et al ARJCCM 2004
 Thank you

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