The Update GINA guideline 2006 in Adult

. . M.D., Ph.D.

Contents
Changing concept in asthma treatment Old GINA guidelines New GINA2006

Changing concept in asthma treatment

short-acting b2-agonists
Bronchospasm

Inh corticosteroid

Combination

Inflammation

Airway Hyperresponsiveness

Remodelling

1975

1980

1985

1990

1995

2000

1995

1995

2002

Six-part Asthma Management Program

Goals of Long-term Management

Achieve and maintain control of symptoms

Prevent asthma episodes or attacks

Maintain pulmonary function as close to normal levels as possible Maintain normal activity levels, including exercise Avoid adverse effects from asthma medications Prevent development of irreversible airflow limitation Prevent asthma mortality

Six-part Asthma Management Program

Control of Asthma
Minimal (ideally no) chronic symptoms

Minimal (infrequent) exacerbations

No emergency visits Minimal (ideally no) need for as needed use of 2agonist No limitations on activities, including exercise PEF circadian variation of less than 20 percent (Near) normal PEF Minimal (or no) adverse effects from medicine

Six-Part Asthma Management Program

1. Educate Patients

2. Assess and Monitor Severity

3. Avoid Exposure to Risk Factors 4. Establish Medication Plans for Chronic Management

1995

5. Establish Plans for Managing Exacerbations

6. Provide Regular Follow-up Care

Pharmacological therapy
Relievers

Controllers

Inhaled fast-acting b2-agonists

Inhaled corticosteroids

Inhaled long-acting b2-agonists Oral anti-leukotrienes Oral theophyllines

Classification of asthma severity: GINA 1995

4
3 1 2 Moderate persistent

Intermittent
Day symptoms
Night symptoms

Mild persistent

Severe Persistent

<1/wk <2/mo >80%

<20%

>1/wk >2/mo >80%

20-30%

daily >1/wk 60-80%

>30%

daily frequent <60%

>30%

PEFR
PF variability

GINA1995

Level 4 Level 3

High dose ICS +other controller high dose ICS ICS B2 agonist prn

Level 2

Level 1

GINA1995 GINA 2002

Level 4 Level 3

High dose ICS ICS+LABA +other controller high dose ICS ICS+LABA ICS B2 agonist prn

Level 2

Level 1

Guidelines Implementation

? ? ? ? ? ? ?
What is the problem?

Classification of asthma severity: GINA 1995

Intermittent
Day symptoms
Night symptoms

Mild persistent

Moderate persistent

Severe Persistent

<1/wk <2/mo
<20%

>1/wk >2/mo
20-30%

daily >1/wk
>30%

daily frequent
>30%

PEFR
PF variability

TOO COMPLICATE >80% >80% 60-80% <60%

Gaining Optimal Asthma controL (GOAL) study

Bateman E. Am. J. Respir. Crit. Care Med.2004:836-844

Common views of control?

Symptoms
Salbutamol use PEF am Night-time awakenings Exacerbations

Some?
A puff a day? >80% on most days? Occasional? Rarely?

Emergency visits
Treatment related adverse events enforcing change in therapy

Rarely? None?

TOTAL CONTROL definition

Symptoms No
Salbutamol use No Everyam PEF day Night-time awakenings No No Exacerbations

Some? Symptoms
Salbutamol use A puff a day? >80% PEF days? >80% on most am Occasional? Night-time awakenings Exacerbations Rarely?

Emergency visits No
Treatment related adverse events No enforcing change in therapy

Rarely? Emergency visits

Treatment related adverse events enforcing None? in therapy change

TOTAL CONTROL is ALL of these sustained for at least 7 of 8 weeks

GOAL Study

GOAL: a unique and innovative study

Phase I Phase II 8-week control assessment 4-week control assessment
SFC 50/500 or FP 500 Oral prednisolone + SFC 50/500

Stratum 3

SFC 50/250 or FP 250

Step 2
SFC 50/500 or FP 500 SFC 50/250 or FP 250

Step 1

Strata 1 & 2
SFC 50/100 or FP 100

Step 3

Step 2

Step 1 Visit Week

1 -4

2 0

3 4

4 12

5 24

6 36

8 9 52 56

SFC, salmeterol/fluticasone propionate combination; FP, fluticasone propionate

GSK data on file, 2003

Patients can achieve total control regardless of asthma severity

% patients achieving total controlled asthma

100 80 60
40%

Seretide Phase 2 Seretide Phase 1 FP Phase 2 FP Phase 1

50% 44% 28% 16% 29%

40 20 0 Steroid nave

Low dose ICS

Moderate dose ICS

Approximately 50% patients achieved Total Control

More patients achieved well controlled asthma with Seretide versus FP

Seretide Phase 2 % patients achieving well-controlled asthma

100 80 60
47% 78% 70% 60% 75%

Seretide Phase 1

FP Phase 2
FP Phase 1

62%

40 20 0

Steroid nave

Low dose ICS

Moderate dose ICS

The recommendations for asthma management are laid out in five interrelated components of therapy:
1. 2. 3. 4. 5. Develop Patient/Doctor Partnership Identify and Reduce Exposure to Risk Factors Assess, Treat, and Monitor Asthma Manage Asthma Exacerbations Special Considerations

Levels of Asthma Control

Characteristic Controlled (All of the following) None (twice or less/week) None None None (twice or less/week) Normal None Partly Controlled (Any measure present in any week) More than twice/week Any Any More than twice/week < 80% predicted or personal best (if known) One or more/year* One in any week Uncontrolled

Daytime symptoms Limitations of activities Nocturnal symptoms/awakening Need for reliever/ rescue treatment Lung function (PEF or FEV1) Exacerbations

Three or more features of partly controlled asthma present

* Any exacerbation should prompt review of maintenance treatment to ensure that it is adequate. By definition, an exacerbation in any week makes that an uncontrolled asthma week. Lung function is not a reliable test for children 5 years and younger.

Pharmacological therapy
Relievers

Controllers

Inhaled fast-acting b2-agonists

Inhaled corticosteroids

Inhaled long-acting b2-agonists Oral anti-leukotrienes Oral theophyllines

GINA1995 GINA 2002

Level 4 Level 3

High dose ICS ICS+LABA +other controller high dose ICS ICS+LABA ICS B2 agonist prn

Level 2

Level 1

Simplified asthma treatment

Asthma Patient

Total control
No day symptoms No night symptoms No rescue medication No ER visit PEFR >80%

Assess Control

Treatment

ICS 500ug/d + ICS 500ug/d Other controller

1995

2002

2006

Implementation

Thank you