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NCT Number: NCT06768736

Early Warning System for Allergic Rhinitis in the MASK-air® App

The primary objective consists in the comparison of the combined symptom medication score values between (i) patients randomised to the early warning system personalised forecasting messages, and (ii) patients randomised to generic messages already delivered by MASK-air®.

The combined symptom medication score has recently been developed in a data-driven way and validated (https://eaaci.org/images/CSMS.pdf); it assesses allergic rhinitis control taking into account both reported symptoms and medication use.

As secondary objectives, visual analogue scales on allergic rhinitis symptoms (VAS global, nasal, eye, asthma), and medication use will also be separately compared.

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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

In patients with allergic rhinitis, forecasting potential exacerbation of symptoms may allow patients to adopt the most adequate preventive measures. In this context, we are developing an early warning system combining atmospheric, pollen, patient symptoms and online activity data.

This early warning system will be incorporated in a mobile health app, and aims to provide patients with messages indicating whether exacerbations are expected in the subsequent five days.

To test the effectiveness of the early warning system in avoiding a worsening of patients' symptoms, undertaking a randomised controlled trial is warranted, particularly comparing personalised forecasting messages versus generic messages.

The clinical study will assess an early warning system, which will be developed through the CATALYSE project. This early warning system will be incorporated in MASK-air®, a mobile health app implemented in 19 European countries, and which allows for patients to register their daily allergic rhinitis symptoms(rhinitis, conjunctivitis and asthma) and medication. The early warning system will be based on: patients' symptom information (as registered in MASK-air®); and atmospheric and pollen forecasts provided by SILAM model and Copernicus systems (which are able to provide forecasts for six main allergic pollen types in Europe, and is able to assimilate new observations registered with an hourly time resolution).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (≥18 years old) of both sexes with clinical diagnosis of allergic rhinitis according to ARIA associated with pollen allergy.

Exclusion criteria

  • Illiterate patients
  • Patients without smartphone
  • Patients who are not able to complete a daily monitoring questionnaire on allergic rhinitis.

Treatment and study plan

Personalised early warning system

Combination Product

Early warning system personalised forecasting messages

Primary outcomes

  1. Combined symptom medication score values

    Time frame: From enrollment to the end of intervention at 2 weeks

    Daily symptom and medication data provided by patients allow the calculation of two validated daily combined symptom-medication scores from formulae previously published:

    • the CSMS (combined symptom-medication score)
    • e-DASTHMA.

Study contacts

Contact information is provided by the study sponsor or research team.

Bernardo Sousa-Pinto, PhD

CONTACT

[email protected]

+351912362153

Sponsors and collaborators

Lead sponsor

Universidade do Porto

Other

Collaborators

  • Centro Hospitalar De São João, E.P.E.

Registry information

Official study title

Randomised Controlled Trial on an Early Warning System for Allergic Rhinitis in the MASK-air® App

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 10, 2025
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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