Adult Pulmonology

Comparative Assessment of Asthma Control Test

(ACT) and GINA Classification including FEV1 in
predicting asthma severity
Maria Monica R. Mendoza, M.D. Bernice Ong-Dela Cruz, MD, Aileen V. Guzman-Banzon, MD;
Fernando G. Ayuyao, MD and Teresita S. De Guia, MD
Background --- The gold standard in classifying severity of asthma is the GINA classification, however, the numeric
cut-off values of frequency and intensity symptoms and parameters of physiologic dysfunction used to classify asthma
severity are artificial and transitory. Currently, asthma questionnaires, such as the Asthma Control Test (ACT), provides
a more simplified assessment of control by not requiring FEV1. It is the aim of this study to compare the Asthma Control
Test (ACT) and GINA classification, including FEV1, in assessing asthma severity and validate ACT as a screening tool
for asthma severity.
Methods --- This is a prospective cohort study involving adult asthmatic patients who were classified based on
their ACT scores into controlled asthma (ACT>19) and uncontrolled asthma (ACT < 19). They were then classified
accordingly to their GINA asthma symptom severity. After which, FEV1 and peak expiratory flow rate (PEFR) were
recorded. Correlation as well as measures of validity were obtained, with level of significance set at 0.05.
Results --- Among the 86 patients included in this study, 62 have ACT scores < 20. The prevalence rate of uncontrolled
asthmatics was 72% with majority classified as moderate persistent. Significant association between ACT and GINA
classification (p-value 0.00), ACT and FEV1 in liter (p-value 0.013), ACT and FEV1 as % predicted (p-value 0.023) and
ACT and PEFR in % predicted (p-value 0.037) were observed. There appeared to be an association between a lower
ACT score and a more severe symptom severity. ACT was 92.3% sensitive and 90.5% specific with AUC of 0.972. The
positive predictive value was 98% and the negative predictive value is 79%.
Conclusion --- With its high sensitivity, specificity and positive predictive value, ACT can served as an alternative
diagnostic tool in assessing asthma severity even without an aid of a spirometer or a peak flow meter. An ACT score of
at least 20 can classify patient as intermittent or controlled asthmatic while an ACT score < 20 can classify the patient
as in persistent or uncontrolled asthmatics. Phil Heart Center J 2007;13(2):149-154.
Key Words: Asthma n GINA n Severity n Validation Study n Asthma Control Test n FEV1

disease in the absence of therapy and is ideally defined

without concurrent treatment confounding its assessment. The in trinsic intensity of the disease, which can
change, but does so only slowly over time. In the presence of the appropriate intervention, including education, environmental control, and pharmacotherapy, many
of the characteristics of disease that we used to describe
severity may be changed or absent.3
More recently, the concept of asthma control has
been introduced to describe better the status of disease
in the presence of intervention. Asthma control describes
the clinical status of disease with medical intervention.
It can rapidly change in response to triggers or therapy.
However, the individual parameters by which we define
asthma severity and asthma control overlap significantly.3
The therapeutic goal is to achieve uncontrolled

sthma is a worldwide disease which affects all ages, sex

and racial groups. In the Philippines, limited reports
showed a prevalence rate of 12% in children
aged 13-14 years old and 12-22% in older age groups.2
In spite of the recent advances in the detection and
treatment of the condition, asthma remains a cause
of significant morbidity and economic burden.
Despite the availability of national and international
guidelines, asthma management is grossly suboptimal
worldwide. The Asthma Insights and Reality in AsiaPacific (AIRIAP) survey, involving asthma subjects from
eight areas including the Philippines, has demonstrated
that the disease causes substantial morbidity, utilization
of healthcare resources and absence from work/
school, especially in those with more severe disease.1
Asthma severity and asthma control are distinct yet related concepts. Asthma severity describes the underlying

Correspondence to Maria Monica R. Mendoza, MD. Division of Adult Cardiology. Philippine Heart Center, East Avenue, Quezon
City, Philippines 1100 Available at http://www.phc.gov.ph/journal/publication copyright by Philippine Heart Center and H.E.A.R.T
Foundation, Inc., 2007 ISSN 0018-9034

149

150 May-Dec 2007

asthmatics to well-controlled then ultimately total controlled. This require aggressive therapy/intervention to
achieve adequate control especially in severe persistent
compared to a mild disease.2 A well-controlled asthmatic should have no or minimal symptoms or use of
rescue medication, no significant limitation in activity
and (near) normal lung function.3 The gold standard in
classifying severity is the GINA classification of asthma
symptom severity which includes daytime and nocturnal symptoms, objective parameters using the FEV1 and
PEF variability.2
Long term mental retention and adherence to the
classification details have not been satisfactory. Because
asthma is a chronic inflammatory disease, the severity of
its chronic state exists in a continuum. Numeric cut-off
values of frequency and intensity symptoms and parameters of physiologic dysfunction currently used to classify asthma in different levels of severity are artificial
and transitory.2 Furthermore, the availability as well as
the affordability of the spirometry is not readily met by
all patients.
Concurrently, many asthma questionnaires were
formulated to make the assessment of asthma severity
and control easy. The most recent and the most simplified questionnaire done by Nathan, et al was the Asthma Control Test (ACT). As a screening tool, the overall agreement between ACT and the specialists rating
ranged from 71% to 78% and the AUC was 0.77. The
ACT provides a more simplified assessment of control
by not requiring FEV1 and by providing a meaningful
and easy to use scoring method, which is simpler than
the other previous asthma questionnaires but comprehensive enough to evaluate the range of asthma control.
Still, the best measure of control would be the use of a
FEV1.10
Objectives

General Objectives
1. To compare the Asthma Control Test (ACT) and GINA
classification including FEV1 in assessing asthma severity.
2. To determine the frequency of uncontrolled asthmatics through Asthma Control Test (ACT).
Specific Objectives
1. To determine the validity of Asthma Control Test
(ACT) as a screening tool in
assessing asthma severity
2. To determine if there is an association between Asthma
Control Test (ACT) and GINA classification of asthma
severity.
3. To determine the association of Asthma Control Test
(ACT) with forced expiratory volume in 1 sec - FEV1(L
and %predicted) and Peak Flow Meter Rate PEFR (L/
min and %predicted).

Methods
This was a prospective cohort study which included
mainly adult asthmatic patients who have been and had
been taking asthmatic medications. Patients younger
than 18 years old and with concomitant lung pathology
such as emphysema, bronchiectasis, bronchitis and tuberculosis were excluded.
The Asthma Control Test (ACT), a validated 5-item
self-administered survey designed to assess asthma control, was administered to the subjects. ACT is scored on
a scale of 5-25 with the higher scores reflective of better asthma control. An ACT score of >19 suggests controlled asthma while ACT score of less than or equal to
19 suggests uncontrolled asthma.
After the Asthma Control Test (ACT), patients had
an interview wherein they were classified according to
the GINA symptom severity. The GINA classification
of symptom severity includes 4 categories mild intermittent, mild persistent, moderate persistent, and severe
persistent. This is based on clinical symptoms including
daytime and nocturnal shortness of breath, spirometric
studies with FEV1 and PEF variability.
After which, spirometric studies and peak expiratory
flow rate were done. They were instructed to blow first
on the Peak Flow Meter or the Mini-Wright followed
by the portable ventilometer or the Microloop. The recorded FEV1 (L and % predicted) and PEFR (L/min and
% predicted) were taken as the best of three satisfactory
results.
Statistical Analysis: Fishers Exact Test and Chisquared test were used to determine association between
variables. Pearson Correlation coefficient was utilized
to determine correlation between FEV 1 and PEFR.
ROC was used to calculate the specificity and sensitivity
of ACT as a screening tool. The level of significance was
set at 0.05.

Results
A total of 86 asthmatic patients were seen at the OutPatient Department. Of these, 62 patients have ACT
score of less than 20, giving a 72% prevalence rate of
uncontrolled asthmatic patients or patients with persistent asthma. On the other hand, 28% of the study population showed ACT score of at least 20, which falls into
the category of intermittent asthma. Table 1 shows that
there was a significant difference between the mean FEV
1 in L (p: 0.013) and in % (p: 0.023) of patients with
ACT score of less than 20 and patients with ACT score
of at least 20. FEV1 < 2L or <80% predicted were associated with ACT score of <20 while FEV1 >2L or >80%
predicted were associated with ACT score of at least 20.
There was also an association between GINA classification of asthma symptom severity and ACT score

Mendoza MMR, et al. Comparative Assessment of ACT and GINA Classification

Table 1. Characteristics of eligible patients grouped
based on their ACT scores

151

Table 3. Comparison of the derived ACT score level with

GINA Classification of Asthma Symptom Severity, FEV1,
PEFR (% predicted)

Table 4. Sensitivity and Specificity of ACT as a screening

tool in assessing asthma severity

Table 2. Derived Asthma Control Test (ACT) scores and

asthma symptom severity using the GINA classification

(p value: 0.00). However, no association were noted with

sex, smoking history and allergic rhinitis and the ACT
score. Both group exhibited almost the same population characteristics; the age ranged between 30 -40 y/o,
> 50% of the subject population were females, majority
were non-smoker(>70%) and a small proportion of asthmatics has concomitant allergic rhinitis (7%).
In Table 2, we could see the breakdown of the different ACT Score in conjunction with the GINA classification of asthma severity. The derived ACT scores were
based on the AIRIAP study by Lai, et.al.9
In our study, 51% of the patient had ACT score of
15-19, which signifies not controlled asthmatic and 21%
had scores below ACT 15 or classified as poorly controlled asthmatics. Based on the GINA classification
of asthma symptom severity, majority of the asthmatics were moderate persistent(40%), followed by mild
persistent(18%) and severe persistent(17%) and lastly,
the mild intermittent(25%). There appeared to be an
association between a lower derived ACT score and a
more severe symptom severity. Although, there was an
overlapping of ACT score for moderate persistent from

ACT 5 to 19, again, it can be classified generally as not

controlled asthmatics..
As we compared the derived ACT score with the
GINA classification and the FEV1, it almost showed the
same association as in Table 1.; ACT scores of 5-14 and
15-19 falls in persistent asthma with a FEV1 <2L while
ACT scores above 20 falls in intermittent asthma with a
FEV1 >2L(Table 3) except for the FEV1(%).
In our study, PEFR (% predicted) was shown to be
associated with the derived ACT scores but not the actual
value of PEFR(L/min). As the ACT scores fall, the PEFR
(% predicted) also fall <60% (Table 3). ACT score is
92.3% sensitive and 90.5% specific with area under the
curve of 0.972 (97.2%). The positive predictive value is
98% and the negative predictive value is 79%. In consequence, ACT score is an excellent diagnostic tool for
screening asthma severity with its high sensitivity and
positive predictive value.

Discussion

Based on NIH(1997), Asthma is now considered as a

disease of airway inflammation. The incessant release of
the inflammatory mediators from eosinophils and mast
cells results in persistent bronchial inflammation of the
airways. Obviously, the airways undergo structural abnormalities resulting in the following: fibrosis, increase
in mass of the smooth muscle and mucus glands, epithelial shedding, thickening of the reticular basement membrane and fibronectin deposition in the subepithelial layer. Histological sections show thickening of the airways
by 50-300% of normal.
Airway remodeling results in the following physiologic consequences: 1) increase in airway hyperre

152 May-Dec 2007

sponsiveness 2) non-reversibility of airway obstruction
and residual obstruction after bronchodilator and antiinflammatory therapy and 3) accelerated decline in the
FEV1 in a subset of asthmatic patients.2
Asthma is diagnosed by a combination of history
(positive family history), clinical findings: 1)cough which
worsens at night, 2) wheeze, 3) dif ficulty of breathing,
4) chest tightness. In addition, objective measurements
of variable airflow obstruction using spirometry(FEV1)
and peak flow meter(PEFR). However, in some cases,
the medical history and PE may not be reliable in diagnosing asthma. Furthermore, the physical examination
maybe normal as asthma symptoms are characteristically episodic especially in children. An objective measure
is needed to diagnose asthma accurately(GRADE A).2
Asthma can be classified according to: 1) etiology 2)
severity (clinical condition on presentation whether the
patient is in acute or in a chronic state). The first classification is limited as no environmental cause can be
identified. For identification of the specific etiology will
guide both the physician and the patient on the use of
avoidance strategies in management.2
The second classification is based on the severity of
the disease. It is important to put emphasis on patient
who are in acute exacerbation such could be fatal if not
treated appropriately.
Even patient with chronic asthma, however mild,
may have an acute exacerbation. Any patient, even with
mild symptoms, should be considered as having asthma
exacerbation if there is: 1) history of life threatening
acute attacks, 2) hospitalization within previous year,
3) psychosocial problem, 4) history of intubation for
asthma, 5) recent reductions or cessation of glucocorticoid therapy, and 6) noncompliance with recommended
medical therapy. These clinical conditions are associated with a higher risk of asthma mortality. Since acute
exacerbation demands an urgent need to intervene and
modify existing treatment.2
Crockcroft and Swystun have suggested that the only
measure that can distinguish asthma severity and asthma
control is the minimal amount of controller medication
required to achieve adequate control. However, this
measure is an accurate reflection of disease severity only
when optimal control has been achieved. Unfortunately, optimal control is not routinely achieved among the
general population which limits the usefulness of such
measure. Therefore, efforts are made to develop measures that accurately classify asthma severity and asthma
control.3
Fuhlbrigge, et.al. assessed asthma burden in the
US using 3 components: Short-term symptom burden(
4-week recall), Long-term symptom burden(past year)
and Functional impact( activity limitation). In this
study, there is a discordance in the pattern of the asthma
symptoms by individuals. Also seen by Colice, et.al.,

evaluation of the asthma severity utilizing individual

component of disease may lead to inadequate treatment
of asthma . Hence, no single variable can give a complete picture of the clinical status of disease. Accurate
assessment requires a combination of parameters.4
Eventually, validated instruments such as questionnaire has developed to evaluate asthma control. The
Asthma Therapy Assessment Questionnaire (ATAQ)
by Vollmer, et.al. showed a significant association between the level of control and healthcare utilization5.
The Asthma Control Questionnaire (ACQ) by Juniper,
et.al. has demonstrated high evaluative and discriminative properties. Recent evidence showed ACQ compared
to the composite measure based by GINA/NIH criteria
showed significant association with the ACQ score and
the severity of the disease.6
The Asthma Control Test, a five item self administered survey which scored from 0 -5; Recent analysis
compared it with the specialist assessment showed a
specificity of 76.2% and a sensitivity of 68.4%7. Nathan,
et al . studied the overall agreement between ACT and
the specialists rating ranged from 71% to 78% and the
AUC was 0.77.10
All questionnaires focus on patient-oriented features
of the disease.4 All 3 describe the impact of asthma on
daily activities, sleep disrupted by asthma and the need
for rescue medication.
Disease severity is not a patient-focused measures,
limited by the requirement that it should be assessed
prior to use of medication and includes measures of lung
function. Unfortunately, these are not performed regularly. In contrast, these 3-survey tools can be assessed in
the presence of controller medications, are not dependent
on the availability of spirometer and report on asthma
control over a longer period of time (1-4wks) depending
on the questionnaire used. Disease severity and control
have the inherent disconnect of the patient with mild disease that is not well controlled or severe disease who has
good contro.l8
There is still a continued debate on how to assess
asthma control in a way supports management and is
easy to use in practice. The ACT questionnaire ask patient to report for the previous 4-weeks( short term recall) regarding: limitations to activities, shortness of
breath, night-time awakening, use of rescue medication,
perception of control. Completion of the ACT results in a
potential score of between 5-25: > or = 20 indicates well
controlled and a score < or = 15 suggests poor controlled
asthma.9
Lai, et al, showed that poorer asthma control, as measured by the derived ACT, was associated with a higher
requirement for hospitalization and unscheduled healthcare over the previous year and elevated healthcost based
on the questionnaires used in the AIRIAP study.9
For ACT of <15, the mean per-patient annual cost

Mendoza MMR, et al. Comparative Assessment of ACT and GINA Classification

of asthma management was US $861, US $319 for patients with a derived ACT score 15-19 and US $193
for patients with derived ACT score of at least 209. As
the ACT scores went down, the expenditure for asthma
care went up which connotes an inverse relationship. As
asthma is not controlled, the more expenses the patient
would incurred.9
In our study, only 24 patients( 28%) has controlled
asthma and the rest were uncontrolled(72%). This substantiates the AIRIAP study which showed that in our
part of the world, the Asia-Pacific region, still asthma is
not totally contained. This should alert us, the physician,
to educate our patient with the nature of the disease that
they have incurred. Still, patient education plays an important role in the control of a disease entity.
According to Nathan, et.al., ACT score of < 19 shows
that most patients are uncontrolled. ACT is a simple, inexpensive test that has been already been validated10.
Stempel, et al, in his study of 522 subjects showe d that
ACT may serve as a useful screening tool in the community
to determine whether patients have controlled or uncontrolled asthma.12
In our study, there was an association noted between
the asthma control test (ACT) and the GINA classification
of asthma symptom severity, FEV1(L and %) as well as
peak expiratory flow rate (% predicted). The ACT score
was able to give a 92.3% sensitive and 90.5% specific
with area under the curve of 0.972 (97.2%). Likewise,
the positive predictive value is 98% and the negative
predictive value is 79%. Consequently, this makes it an
excellent diagnostic tool for screening asthma severity.
Our findings has corroborated with the above studies.
An ACT score of at least 20 can classify patient as
in intermittent or controlled asthmatics with an of FEV1
and PEFR of >80% predicted while an ACT score of less
than 20 can classify the patient as in persistent or uncontrolled asthmatics with an FEV1 and PEFR of < 80%
predicted.
In the GOAL study, it was designed to assess whether
total control or well control status was achievable. This
study demonstrated that well or total control of asthma
could be attained in the majority of the patients treated
with a salmeterol/fluticasone combination. Although
control was established at a high threshold, majority of
the patients were able to achieve and sustain well or total
asthma control. This allows for the establishment of a
new goal for assessing asthma outcomes.13
In our study, majority of the patients interviewed
do not have any controller medication. Only 32
asthmatics(37%) of the study population has used combination beta-agonist and steroids. Not all of them are
maintained on a regular basis, some have stopped due to
financial constraint, some are still using on a p.r.n. basis
and luckily, a few are able sustain its use. Hence, majority of them falls into the category of moderate persistent.

153

Using the patient-oriented concept thru asthma control

test (ACT), we hope that detecting uncontrolled asthmatics would be easier, leading to a better adherence to
the controller medication and ultimately, a better or total
control of asthmatic patients in our country.
Limitations

This study is limited by the relatively small sample size

and could lead to variations in values that may not be
reflective of the larger, general population specifically
the asthmatics. Another is the objectivity analysis of the
investigator assessment as the gold standard which is
to classify the patients according to the GINA asthma
symptom severity. Nonetheless, the magnitude of association flow meter are not readily available. Despite
its limitation, this study has demonstrated asthma control test (ACT) with a high positive predictive value as
well as high sensitivity and specificity making it a good
screening tool in asthmatics. between the asthma control
test and GINA classification asthma symptom severity
as well as FEV1(L and %) and PEFR(%) indicates that
asthma control test (ACT) can be used as a surrogate test
in assessing asthma severity especially in places where
spirometry as well as peak

Conclusion
With its high sensitivity, specificity and positive predictive value, asthma control test (ACT) can served as an
alternative diagnostic tool in assessing asthma severity
even with out an aid of a spirometer or a peak flow meter in an out-patient basis or as home based. An ACT
score of at least 20 can classify patient as intermittent
or controlled asthmatics with an of FEV1 and PEFR of
>80% predicted while an ACT score of less than 20 can
classify the patient as persistent or uncontrolled asthmatics with an FEV1 and PEFR of < 80% predicted. It can
serve as a guide in the case management of asthmatic
patients. Therefore, asthma control test (ACT) is a simple, inexpensive tool that can be used especially in our
country where financial resources are limited, disabling
our patient to do the standard diagnostic test such as the
spirometry.

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