Asthma and lower airway disease
Symptom- and fraction of exhaled nitric oxide–driven strategies for asthma control: A cluster-randomized trial in primary care

https://doi.org/10.1016/j.jaci.2014.07.016Get rights and content

Background

Aiming at partly controlled asthma (PCa) instead of controlled asthma (Ca) might decrease asthma medication use. Biomarkers, such as the fraction of exhaled nitric oxide (Feno), allow further tailoring of treatment.

Objective

We sought to assess the cost-effectiveness and clinical effectiveness of pursuing PCa, Ca, or Feno-driven controlled asthma (FCa).

Methods

In a nonblind, pragmatic, cluster-randomized trial in primary care, adults (18-50 years of age) with a doctor's diagnosis of asthma who were prescribed inhaled corticosteroids were allocated to one of 3 treatment strategies: (1) aiming at PCa (Asthma Control Questionnaire [ACQ] score <1.50); (2) aiming at Ca (ACQ score <0.75); and (3) aiming at FCa (ACQ score <0.75 and Feno value <25 ppb). During 12 months' follow-up, treatment was adjusted every 3 months by using an online decision support tool. Outcomes were incremental cost per quality-adjusted life year gained, asthma control (ACQ score), quality of life (Asthma Quality of Life Questionnaire score), asthma medication use, and severe exacerbation rate.

Results

Six hundred eleven participants were allocated to the PCa (n = 219), Ca (n = 203), or FCa (n = 189) strategies. The FCa strategy improved asthma control compared with the PCa strategy (P < .02). There were no differences in quality of life (P ≥ .36). Asthma medication use was significantly lower for the PCa and FCa strategies compared with the Ca strategy (medication costs: PCa, $452; Ca, $551; and FCa, $456; P ≤ .04). The FCa strategy had the highest probability of cost-effectiveness at a willingness to pay of $50,000/quality-adjusted life year (86%; PCa, 2%; Ca, 12%). There were no differences in severe exacerbation rate.

Conclusion

A symptom- plus Feno-driven strategy reduces asthma medication use while sustaining asthma control and quality of life and is the preferred strategy for adult asthmatic patients in primary care.

Section snippets

Methods

This was an entirely investigator-designed and investigator-driven study. A detailed description of study procedures, sample size calculation, and measurements has been published elsewhere.22

Recruitment and baseline characteristics

Fig 1 provides the flowchart of the study. Between September 2009 and January 2012, 611 asthmatic patients participated, of whom 219 (in 44 clusters) were allocated to the PCa strategy, 203 (43 clusters) to the Ca strategy, and 189 (44 clusters) to the FCa strategy. All initially started general practices (clusters) completed the study.

Participants' baseline characteristics were similar for the 3 strategies (Table II). Table E2 in this article's Online Repository at www.jacionline.org shows a

Discussion

In this pragmatic cluster-randomized trial in patients with mild to moderately severe asthma in primary care, we found that a treatment approach aiming at PCa instead of Ca significantly decreases asthma medication use and associated costs, whereas asthma control, quality of life, and severe exacerbation rates remain similar. However, a strategy aiming at Ca that is additionally driven by a Feno measurement seems to be the preferred strategy because it also reduces asthma medication use and

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    Supported by the Netherlands Organisation for Health Research and Development (ZON-MW, sub-programme Effects & Costs 80-82310-98-8627), and by the Netherlands Asthma Foundation (NAF 3.4.07.044). Aerocrine (Solna, Sweden) provided 20 of a total of 40 fraction of exhaled nitric oxide meters for free.

    Disclosure of potential conflict of interest: This study was funded by the Netherlands Organization for Health Research and Development and the Netherlands Asthma Foundation and received nonfinancial support from Aerocrine. J. B. Snoeck-Stroband holds stock in Grace Bros and has received consultancy fees from AstraZeneca, GlaxoSmithKline, and Novartis, as well as grant funding from ACME Pharmaceutical. J. K. Sont has received research grants from Boehringer Ingelheim, GlaxoSmithKline, Chiesi, and Fonds NutsOhra (1101-081), as well as nonfinancial support from AstraZeneca (3.4.07.044). The rest of the authors declare that they have no other relevant conflicts of interest.

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