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

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.