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

Last updated: April 9, 2024
Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Overall Status: Active - Recruiting

Phase

N/A

Condition

Allergies & Asthma

Asthma

Treatment

PDO Group

Clinical Study ID

NCT06320119
2943
  • Ages > 18
  • All Genders

Study Summary

To optimize the effectiveness of asthma therapy there is a need to identify and address individual patient goals. Considering the self-management discussion as central for the achievement of health outcomes, Healthcare Providers may help patients make specific actions to obtain their desired goals.

The current evidence suggest that Healthcare Professionals need to develop a more patient-centered and partnership-based approach based on the development and review of action plans, including the experiential asthma knowledge of patients and caregivers. From a practical perspective, the specialist (i.e. pulmunologists, allergologists, etc) has clear therapeutic targets to be reached in asthmatic patients: for example, improving the disease control, the spirometric values and asthma control test (ACT) score vs. pre-treatment evaluations represent the standard outcomes to reach (GINA 2019). However, as previously described, patients are more likely to achieve an improved clinical outcome when the treatment is driven by a personalized goal. This builds on the same principle as shared decision making between the physician and patient, recognizing both the personal motivation and the accountability on behalf of the patient (Hoskins et al. 2016).

This study aims to evaluate if the identification of a personalized outcome allows patients to achieve a better control of asthma in terms of asthma control test (ACT) and asthma quality of life questionnaire (AQLQ). In addition, a set of clinical outcomes (i.e. forced expiratory volume in one second - FEV1, use of rescue therapy, night awakeness) will also be assessed.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male and female patients aged ≥18 years;
  2. Patients with a documented diagnosis of mild/moderate asthma, according to GINA, forat 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 nomore than 10 pack/year, according the WHO definition);
  6. Patients able to set up a personal outcome according to the protocol instruction, andwilling 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

Exclusion Criteria:

  1. Patients treated with oral corticosteroids (OCS) and/or biological for severerefractory 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 orother 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 (includinguncontrolled diabetes or thyroid disease) or hematological abnormalities that areuncontrolled. Significant is defined as any disease that, in the opinion of theInvestigator, would put the safety of the subject at risk through participation, orwhich would affect the efficacy or safety analysis if the disease/conditionexacerbated during the study.
  5. Subjects with a history of psychiatric disease, intellectual deficiency, poormotivation or other conditions that will limit the validity of informed consent toparticipate in the study.

Study Design

Total Participants: 190
Treatment Group(s): 1
Primary Treatment: PDO Group
Phase:
Study Start date:
January 01, 2023
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • ASST Papa Giovanni XXIII

    Bergamo, 24127
    Italy

    Active - Recruiting

  • Azienda ospedaliera Spedali Civili di Brescia

    Brescia, 25123
    Italy

    Active - Recruiting

  • Ospedale San Martino di Genova

    Genova, 16132
    Italy

    Active - Recruiting

  • ASST Fate Bene e Fratelli Sacco

    Milan, 20100
    Italy

    Active - Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20100
    Italy

    Site Not Available

  • ASST Santi Paolo e Carlo

    Milan, 20100
    Italy

    Active - Recruiting

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano

    Milano, 20122
    Italy

    Active - Recruiting

  • Policlinico San Matteo

    Pavia, 27100
    Italy

    Active - Recruiting

  • Ospedale di Rovigo

    Rovigo, 45100
    Italy

    Active - Recruiting

  • Humanitas Hospital - UO Allergologia

    Rozzano, 20089
    Italy

    Active - Recruiting

  • Humanitas Hospital - UO Pneumologia

    Rozzano, 20089
    Italy

    Site Not Available

  • Istituti Clinici Scientifici Maugeri, IRCCS Tradate

    Tradate, 21049
    Italy

    Active - Recruiting

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