Personalized outcomes for asthma management

Setting a PERSONalized Outcome in ASthma: the PERSONAS Study. A Patient Driven Outcome (PDO) Study

This study is testing a new way to manage asthma by creating personalized action plans with patients to see if it helps them feel better and manage their symptoms more effectively.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 190 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico (other)
• Locations: 12 sites (Bergamo and 11 other locations)
• Trial ID: NCT06320119 on ClinicalTrials.gov

What this trial studies

This study aims to enhance asthma therapy by focusing on individual patient goals and self-management strategies. It emphasizes a partnership-based approach between healthcare providers and patients, allowing for the development and review of personalized action plans. The study targets patients with mild to moderate asthma who have been on chronic inhaled treatment and aims to improve clinical outcomes through tailored interventions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with mild to moderate asthma who are on chronic inhaled treatment and can engage in setting personal health goals.

Not a fit: Patients with severe refractory asthma or those currently using oral corticosteroids may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to better asthma control and improved quality of life for patients.

How similar studies have performed: Previous studies have indicated that patient-centered approaches can lead to improved health outcomes, suggesting potential success for this novel approach.

Eligibility criteria

Inclusion Criteria:

1. Male and female patients aged ≥18 years;
2. Patients with a documented diagnosis of mild/moderate asthma, according to GINA, for at least 6 months before visit 1;
3. Patients on LABA/ICS chronic inhaled treatment (\> 4 weeks before visit 1);
4. ACT values \<20 points
5. No smoking patients, or former smokers (at least 1 year since quitting smoking, and no more than 10 pack/year, according the WHO definition);
6. Patients able to set up a personal outcome according to the protocol instruction, and willing to improve their personal outcome;
7. Patients able to understand written and spoken Italian;
8. Patients who give their informed consent to participate in the study.

Exclusion Criteria:

1. Patients treated with oral corticosteroids (OCS) and/or biological for severe refractory asthma;
2. Patients treated with OCS for any other chronic disease;
3. Subjects with current evidence of chronic obstructive pulmonary disease (COPD), pneumonia, active tuberculosis, active lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases or respiratory abnormalities other than asthma;
4. Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
5. Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study.

Where this trial is running

Bergamo and 11 other locations

• ASST Papa Giovanni XXIII — Bergamo, Italy (RECRUITING)
• Azienda ospedaliera Spedali Civili di Brescia — Brescia, Italy (RECRUITING)
• Ospedale San Martino di Genova — Genova, Italy (RECRUITING)
• Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano — Milano, Italy (RECRUITING)
• ASST Fate Bene e Fratelli Sacco — Milan, Italy (RECRUITING)
• ASST Grande Ospedale Metropolitano Niguarda — Milan, Italy (NOT_YET_RECRUITING)
• ASST Santi Paolo e Carlo — Milan, Italy (RECRUITING)
• Policlinico San Matteo — Pavia, Italy (RECRUITING)
• Ospedale di Rovigo — Rovigo, Italy (RECRUITING)
• Humanitas Hospital - UO Allergologia — Rozzano, Italy (RECRUITING)
• Humanitas Hospital - UO Pneumologia — Rozzano, Italy (NOT_YET_RECRUITING)
• Istituti Clinici Scientifici Maugeri, IRCCS Tradate — Tradate, Italy (RECRUITING)

Study contacts

• Study coordinator: Francesco Blasi, Prof.

Conditions: Bronchial Asthma