Long-term tracking and profiling of adults with mild to severe asthma

A Study of Mild, Moderate and Severe Asthma: Characterisation of Phenotypes and Endotypes and Longitudinal Associations With Exacerbations, Triggers and Disease Progression (MAPLE-UK)

We will follow adults with mild, moderate, or severe asthma to see if yearly clinic visits plus at-home monitoring reveal patterns in symptoms, triggers, and airway inflammation over time.

Quick facts

• Study type: Observational
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hvivo (Industry-sponsored)
• Locations: 1 site (London)
• Trial ID: NCT07189806 on ClinicalTrials.gov

What this trial studies

This is a prospective observational registry enrolling adults (≥18) with clinician-diagnosed asthma at the hVIVO respiratory site, including a wide spectrum of severity and Type 2 high and low participants. Participants have a baseline clinic visit and are expected to attend about five annual clinic visits with interim at-home self-monitoring roughly halfway between visits, with follow-up calls as needed. Data collected will include clinical measures, respiratory and blood biomarkers, exacerbation history, and trigger/exposure information to characterize variability, stability, and progression of disease. The registry is open-ended with an initial cohort target of at least 235 participants and plans for monitoring longer-term outcomes for at least five years.

Who should consider this trial

Good fit: Adults aged 18 or older who attend the hVIVO respiratory clinic, have a clinical diagnosis of asthma, and are willing to complete yearly visits and periodic at-home monitoring are ideal candidates.

Not a fit: Patients who do not attend hVIVO clinics, whose main respiratory diagnosis is not asthma, or who expect direct therapeutic intervention are unlikely to gain clinical benefit from participation.

Why it matters

Potential benefit: If successful, the findings could help predict which patients are more likely to worsen and inform more personalized monitoring or treatment to reduce exacerbations.

How similar studies have performed: Other longitudinal asthma cohorts and registries have identified useful biomarkers and risk factors but predictive models remain imperfect, so this approach builds on partially successful prior work.

Eligibility criteria

Inclusion Criteria:

1. Male or Female patients aged ≥ 18 years and older who have signed an Informed Consent form.
2. All patients who attend the hVIVO respiratory site clinics who have a clinical diagnosis of asthma/any of the following:

   * Positive response to methacholine challenge test (AHR), or
   * Positive response to a bronchodilator responsiveness test, or
   * Peak Flow variability (i.e. highest - lowest PEF over the day/mean value of the two, × 100) \> 20%, or
   * Documented response (defined as ΔFEV1 ≥ 12% and ≥ 200 mL) after a cycle (e.g., 4 weeks) of regular maintenance anti-asthma treatment, or
   * physician diagnosis of current asthma.
3. In the PI/investigator(s) opinion, will be able to follow the study requirements.

Exclusion Criteria:

1. Asthma patients who are not attending hVIVO respiratory site clinics.
2. Patients whose primary respiratory diagnosis (i.e. the condition causing most of their respiratory symptoms) is not asthma (however, a co-diagnosis of another respiratory disease such as COPD, bronchiectasis or interstitial lung disease together with asthma will be accepted)
3. Females who:

   1. Are breastfeeding, or
   2. Have a positive pregnancy test at any point during screening
4. Patients who, in the opinion of the physician, are unlikely to complete the 5 years of follow-up, e.g. poor literacy, substance abuse, life threatening comorbidities.
5. Contraindications for lung function testing, e.g., hemoptysis of unknown origin, history of pulmonary hypertension, previous pneumothorax, unstable cardiovascular status (severe heart failure, or ischemic heart disease), aneurysms (thoracic, abdominal or cerebral), recent eye surgery (e.g., cataract), recent thoracic or abdominal surgery.
6. Patients with lifetime history of anaphylaxis and/or a lifetime history of severe allergic reaction

Where this trial is running

London

• hVIVO Services Limited, 40 Bank Street — London, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Alexandre Lima, MD-PhD — Hvivo
• Study coordinator: Alex Mann

Conditions Asthma; Severe; Moderate; Mild; Exacerbations; Longitudinal; Observational; Dyspnea