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DOI: 10.1055/s-0037-1619158
Impact of Asthma Control Status on Lung Function and Patient Well-Being Assessments in Patients with Severe, Uncontrolled Asthma
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.
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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