Nocturnal temperature controlled laminar airflow for treating atopic asthma: a randomised controlled trial

Robert J Boyle, Christophe Pedroletti, Magnus Wickman, Leif Bjermer, Erkka Valovirta, Ronald Dahl, Andrea Von Berg, Olof Zetterström, John O Warner, 4A Study Group, Robert J Boyle, Christophe Pedroletti, Magnus Wickman, Leif Bjermer, Erkka Valovirta, Ronald Dahl, Andrea Von Berg, Olof Zetterström, John O Warner, 4A Study Group

Abstract

Objective: To determine whether environmental control using nocturnal temperature controlled laminar airflow (TLA) treatment could improve the quality of life of patients with persistent atopic asthma.

Design: Randomised, double-blind, placebo-controlled, parallel-group trial. Setting Nineteen European asthma clinics.

Participants: 312 patients aged 7-70 with inadequately controlled persistent atopic asthma.

Main outcome measure: Proportion of patients with an increase of ≥0.5 points in asthma quality of life score after 1 year of treatment.

Results: TLA devices were successfully installed in the bedrooms of 282 (90%) patients included in the primary efficacy analysis. There was a difference in treatment response rate between active (143 of 189, 76%) and placebo (56 of 92, 61%) groups, difference 14.8% (95% CI 3.1 to 26.5, p=0.02).3 In patients aged ≥12, on whom the study was powered, the difference in response rate was similar-active 106 of 143 (74%), placebo 42 of 70 (60%), difference 14.1% (0.6 to 27.7, p=0.059). There was a difference between groups in fractional exhaled nitric oxide change of -7.1 ppb (-13.6 to -0.7, p=0.03). Active treatment was associated with less increase in cat-specific IgE than placebo. There was no difference in adverse event rates between treatment groups.

Conclusion: Inhalant exposure reduction with TLA improves quality of life, airway inflammation and systemic allergy in patients with persistent atopic asthma. TLA may be a treatment option for patients with inadequately controlled persistent atopic asthma. Trial registration number Clinical Trials NCT00986323.

Conflict of interest statement

Competing interests: None.

Figures

Figure 1
Figure 1
Participant flow through the trial.
Figure 2
Figure 2
Treatment response rate in patients treated with temperature controlled laminar airflow (TLA) or a placebo device for 1 year, defined as an increase in Asthma Quality of Life Questionnaire score of either ≥0.5 or ≥1.0 point. Data are shown for the total study population (n=282), those with high treatment intensity at baseline (Global Initiative for Asthma, GINA 4; n=129), poor asthma control at baseline (Asthma Control Test, ACT

Figure 3

Change in Asthma Quality of…

Figure 3

Change in Asthma Quality of Life Questionnaire (AQLQ) score during 1 year of…

Figure 3
Change in Asthma Quality of Life Questionnaire (AQLQ) score during 1 year of temperature controlled laminar airflow (TLA) (blue line) or placebo (dotted red line) treatment in the whole population (All), those with highest asthma treatment intensity at baseline (Global Initiative for Asthma, GINA 4), those with poor asthma control at baseline (Asthma Control Test, ACT
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Figure 3
Figure 3
Change in Asthma Quality of Life Questionnaire (AQLQ) score during 1 year of temperature controlled laminar airflow (TLA) (blue line) or placebo (dotted red line) treatment in the whole population (All), those with highest asthma treatment intensity at baseline (Global Initiative for Asthma, GINA 4), those with poor asthma control at baseline (Asthma Control Test, ACT

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