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.


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