# The effect of a systematic multi-dimensional assessment in severe uncontrolled asthma: a literature review and protocol for an investigator-initiated, open-label, randomized-controlled trial (EXACT@home study)

## TL;DR

This study aims to evaluate if a systematic assessment of treatable traits in severe asthma can reduce the need for costly biological treatments.

## Contribution

The study proposes a novel randomized-controlled trial protocol to assess the effectiveness of a systematic multi-dimensional evaluation in managing severe uncontrolled asthma.

## Key findings

- Literature review found limited evidence on systematic assessments in severe asthma due to inconsistent study designs.
- The EXACT@home trial will investigate if a 6-week assessment program can reduce biological prescriptions and improve asthma control.
- The study will track outcomes like quality of life and exacerbation frequency over 12 months.

## Abstract

Severe asthma affects 3.6% of the asthma population, in which patients are uncontrolled despite optimal drug therapy and management of treatable traits. These patients are eligible for treatment with biologicals, which provide significant benefits but are costly and need precise indication. However, identifying all individual treatable traits before diagnosing severe asthma is challenging. A systematic multi-dimensional assessment may help identify and address these hidden traits, resulting in tailored treatment and reducing the number of unnecessary biological prescriptions.

A literature review was conducted to address the knowledge gap on the effectiveness and added value of a systematic assessment and treatment in difficult-to-treat or severe asthma, followed by an outline of a study protocol to implement this in patients diagnosed with severe asthma.

The literature review revealed limited evidence on the effectiveness of systematic assessments in difficult-to-treat or severe asthma, largely due to the use of different study methods and outcome measures. Notably, only one of the selected articles employed a randomized controlled design. To address this gap, the EXpert Asthma Copd Trajectory with digital support (EXACT@home) study was proposed, which aims to improve the assessment and treatment of treatable traits in severe asthma before (re)considering treatment with biologicals. This study uses a prospective, open label, randomized controlled trial design with the primary aim of reducing biological prescriptions. Patients are eligible for inclusion if they have previously been diagnosed with severe uncontrolled asthma with an indication for treatment with biologicals. The intervention arm undergoes a 6-week systematic assessment program targeting treatable traits followed by tailored treatment, while the control arm directly receives treatment with biologicals. Both arms are followed for 12 months with secondary outcomes including asthma control, quality of life and exacerbation frequency.

Difficult-to-treat or severe asthma requires tailored treatments based on individual treatable traits, but challenges remain in accurately identifying these traits. Existing literature highlights the beneficial effects of systematic assessments, but conclusive evidence is lacking. The EXACT@home study aims to provide high quality evidence on the effectiveness of such an assessment in the management of severe uncontrolled asthma, addressing a gap in the current literature.

NCT05831566 (Clinicaltrials.gov), registered at 14–04-2023.

Protocol version: version 6, date 27–03-2024.

The online version contains supplementary material available at 10.1186/s12890-025-03646-5.