Pneumologie 2018; 72(S 01): S16
DOI: 10.1055/s-0037-1619158
Sektion 7 – Klinische Pneumologie
Posterbegehung – Titel: Asthma I
Georg Thieme Verlag KG Stuttgart · New York

Impact of Asthma Control Status on Lung Function and Patient Well-Being Assessments in Patients with Severe, Uncontrolled Asthma

X Xu
1  Astrazeneca, Gaithersburg, MD, USA
,
S O'Quinn
1  Astrazeneca, Gaithersburg, MD, USA
,
I Hirsch
1  Astrazeneca, Gaithersburg, MD, USA
,
G Gopalan
1  Astrazeneca, Gaithersburg, MD, USA
› Author Affiliations
Further Information

Publication History

Publication Date:
21 February 2018 (online)

 

Introduction:

Beyond asthma-related quality of life (QOL), limited data are available for relationships between asthma control status and patients' subjective well-being. We assessed the associations of degree of asthma control with lung function and different aspects of well-being for patients with severe, uncontrolled asthma.

Tab. 1:

Comparisons of FEV1 and Patient Well-Being Assessments by Symptom Control Status Defined According to GINA 2016 Classifications

Control Status Defined According to

GINA 2016 Classifications

Well-Controlled

Partially Controlled

Uncontrolled

Outcomes

Measures

(n = 39)

(n = 186)

(n = 294)

LS mean

1.97

1.86

1.71

FEV1 (L)

Difference (95% CI) (vs. uncontrolled)

0.26 (0.15, 0.38)

0.15 (0.06, 0.24)

-

P-value

< 0.001

< 0.001

LS mean

0.57

1.42

2.55

ACQ-6

Difference (95% CI) (vs. uncontrolled)

-1.98 (-2.19, -1.76)

-1.12 (-1.29, -0.96)

-

P-value

< 0.001

< 0.001

LS mean

6.29

5.32

4.42

AQLQ(s)+12:

overall

Difference (95% CI) (vs. uncontrolled)

1.87 (1.63, 2.11)

0.89 (0.72, 1.07)

-

P-value

< 0.001

< 0.001

LS mean

6.35

5.35

4.30

AQLQ(s)+12:

symptoms

Difference (95% CI) (vs. uncontrolled)

2.05 (1.80, 2.30)

1.04 (0.86, 1.23)

-

P-value

< 0.001

< 0.001

LS mean

6.28

5.27

4.46

AQLQ(s)+12

activity limitation

Difference (95% CI) (vs. uncontrolled)

1.82 (1.58, 2.07)

0.82 (0.64,1.00)

-

P-value

< 0.001

< 0.001

LS mean

6.33

5.42

4.48

AQLQ(s)+12

emotional

function

Difference (95% CI) (vs. uncontrolled)

1.85 (1.56, 2.15)

0.94 (0.72, 1.17)

-

P-value

< 0.001

< 0.001

AQLQ(s)+12

environmental

stimulation

LS mean

6.09

5.22

4.56

Difference (95% CI) (vs. uncontrolled)

1.52 (1.22, 1.82)

0.66 (0.44, 0.89)

-

P-value

< 0.001

< 0.001

LS mean

0.14

0.25

0.49

Daily diary:

stress

Difference (95% CI) (vs. uncontrolled)

-0.35 (-0.44, -0.26)

-0.24 (-0.30, -0.17)

-

P-value

< 0.001

< 0.001

LS mean

0.40

1.20

1.74

Daily diary:

feeling tired

Difference (95% CI) (vs. uncontrolled)

-1.35 (-1.50,-1.19)

-0.54 (-0.66, -0.43)

-

P-value

< 0.001

< 0.001

LS mean

0.32

1.06

1.62

Daily diary:

avoidance of

activities

Difference (95% CI) (vs. uncontrolled)

-1.31 (-1.46, -1.15)

-0.57 (-0.68, -0.45)

-

P-value

< 0.001

< 0.001

LS mean

0.40

1.18

1.72

Daily diary: need

to pace oneself

Difference (95% CI) (vs. uncontrolled)

-1.33 (-1.49,-1.16)

-0.55 (-0.67, -0.43)

-

P-value

< 0.001

< 0.001

ACQ-6. Asthma Control Questionnaire, 6-quesuon version; AQLQ(S)+12. Standardized Asthma Quality of Life Questionnaire for patients 12 years and older; CI, confidence interval; FEV1, forced expiratory volume in 1 second; GINA, Global Initiative for Asthma; LS, least squares.

Methods:

This analysis used pooled data for adults with severe asthma who received placebo plus high-dosage inhaled corticosteroids plus long-acting β2-agonists (ICS/LABA) in the Phase III SIROCCO (Lancet. 2016;388:2115 – 27) and CALIMA (Lancet. 2016;388:2128 – 41) trials. Patients received placebo by subcutaneous injection every 4 weeks. Daily electronic diaries captured asthma symptoms; activity function (activity limitations, activity avoidance, and need to pace oneself during activities); stress; feeling tired; rescue medication use; night-time awakenings; Asthma Control Questionnaire, 6-question version (ACQ-6); and Standardized Asthma QOL Questionnaire for patients 12 years and older (AQLQ[S]+12). Patients were placed into one of the following Global Initiative for Asthma (GINA) 2016 symptom control classifications based on the number of 4 daily diary items marked yes: well-controlled (0), partly controlled (1 – 2), or uncontrolled (3 – 4).

Results:

By end of placebo administration, 89, 186, and 294 patients based on GINA classifications were well-controlled, partially controlled, and uncontrolled, respectively, which corresponded well with ACQ-6-defined control status. Uncontrolled patients had substantially worse forced expiratory volume in 1 second (FEV1; mean difference [MD]: 0.15 to 0.26 L), worse QOL (AQLQ[S]+12 overall score, MD: 0.89 to 1.87), greater stress (MD: –0.24 to –0.35), more feelings of tiredness (MD: –0.54 to –1.35), more avoidance of activities (MD: –0.57 to –1.31), and greater need to pace oneself during activities (MD: –0.55 to –1.33) compared with well-controlled or partially controlled patients (all nominal p < 0.001) (table).

Conclusions:

Patients with severe, uncontrolled asthma who received placebo plus high-dosage ICS/LABA had substantially lower FEV1 values and worse results in measurements of well being compared with patients with well- or partially controlled disease.