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

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.

Study Overview

• Status: Recruiting
• Conditions: Bronchial Asthma
• Intervention / Treatment: Other: PDO Group

• Study Type: Interventional
• Enrollment (Estimated): 190
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francesco Blasi, Prof.; Phone Number: +390250320627; Email: francesco.blasi@unimi.it
• Study Contact Backup: Name: Maura Spotti, PhD; Phone Number: +393336216405; Email: maura.spotti@policlinico.mi.it

Study Locations

• Italy
  • Bergamo, Italy, 24127
    • Recruiting
    • Asst Papa Giovanni XXIII
    • Contact: Fabiano Di Marco, Prof.
  • Brescia, Italy, 25123
    • Recruiting
    • Azienda Ospedaliera Spedali Civili di Brescia
    • Contact: Laura Pini, Prof.
  • Genova, Italy, 16132
    • Recruiting
    • Ospedale San Martino di Genova
    • Contact: Fulvio Braido, Prof.
  • Milan, Italy, 20100
    • Recruiting
    • ASST Fate Bene e Fratelli Sacco
    • Contact: Pierachille Santus
  • Milan, Italy, 20100
    • Not yet recruiting
    • ASST Grande Ospedale Metropolitano Niguarda
    • Contact: Paolo Tarsia, Prof.
  • Milan, Italy, 20100
    • Recruiting
    • Asst Santi Paolo E Carlo
    • Contact: Stefano Centanni, Prof.
  • Milano, Italy, 20122
    • Recruiting
    • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano
    • Contact: Francesco Blasi, Prof.; Phone Number: +390250320627; Email: francesco.blasi@unimi.it
  • Pavia, Italy, 27100
    • Recruiting
    • Policlinico San Matteo
    • Contact: Angelo Corsico, Prof.
  • Rovigo, Italy, 45100
    • Recruiting
    • Ospedale di Rovigo
    • Contact: Gianluca Casoni, Dott.
  • Rozzano, Italy, 20089
    • Recruiting
    • Humanitas Hospital - UO Allergologia
    • Contact: Enrico Heffler
  • Rozzano, Italy, 20089
    • Not yet recruiting
    • Humanitas Hospital - UO Pneumologia
    • Contact: Stefano Aliberti, Prof.
  • Tradate, Italy, 21049
    • Recruiting
    • Istituti Clinici Scientifici Maugeri, IRCCS Tradate
    • Contact: Antonio Spanevello, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Personal approach on asthma control (PDO group)	Other: PDO Group; Patients in the intervention gruop with set a personalized outcome within a usual asthma review consultation
No Intervention: Non-personalized approach (UC group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome. The primary outcome of the study is to evaluate the impact of the personalized approach on asthma control (PDO group) versus a non-personalized approach (UC group).	The primary outcome of the study is to evaluate the impact of the personalized approach on asthma control (PDO group) versus a non-personalized approach (UC group). Primary outcome will be measured at month 3 by asthma control test (ACT).	Primary outcome will be measured at month 3 by asthma control test (ACT).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Outcome. To evaluate the impact of the personalized approach on asthma control (PDO group) versus a non-personalized approach (UC group) assessed by the change of ACT from month 3 to month 6.	To evaluate the impact of the personalized approach on asthma control (PDO group) versus a non-personalized approach (UC group) assessed by the change of ACT from month 3 to month 6. Patients with an increase in the ACT score of 3 or greater will be considered responders. The secondary outcome will be calculated as the difference in percentage of the responders in each of the two groups;	from month 3 to month 6
Secondary outcome. To evaluate the impact of the personalized approach on asthma control (PDO group) versus a non-personalized approach (UC group) assessed by the change of AQLQ from baseline to month 3.	To evaluate the impact of the personalized approach on asthma control (PDO group) versus a non-personalized approach (UC group) assessed by the change of AQLQ from baseline to month 3. Patients with an increase in total AQLQ score of at least 0.5 points will be considered responders. The outcome will be calculated as the difference in percentage of the responders in each of the two groups.	from baseline to month 3
Secondary outcome. To evaluate the impact of the personalized approach on asthma control (PDO group) versus a non-personalized approach (UC group) assessed by the change of AQLQ from month 3 to month 6.	To evaluate the impact of the personalized approach on asthma control (PDO group) versus a non-personalized approach (UC group) assessed by the change of AQLQ from month 3 to month 6. Patients with an increase in total AQLQ score of at least 0.5 points will be considered responders. The outcome will be calculated as the difference in percentage of the responders in each of the two groups.	from month 3 to month 6;
Secondary outcome. To evaluate the impact of the personalized approach on asthma control assessed by the change of lung function (pulmonary functions tests: FEV1, FVC, FEV1/FVC) from baseline to month 3.	To evaluate the impact of the personalized approach on asthma control assessed by the change of lung function (pulmonary functions tests: FEV1, FVC, FEV1/FVC) from baseline to month 3.	from baseline to month 3
Secondary outcome. To evaluate the impact of the personalized approach on asthma control assessed by the change of lung function (pulmonary functions tests: FEV1, FVC, FEV1/FVC) from baseline from month 3 to month 6.	To evaluate the impact of the personalized approach on asthma control assessed by the change of lung function (pulmonary functions tests: FEV1, FVC, FEV1/FVC) from baseline from month 3 to month 6.	from month 3 to month 6
Secondary outcome. To measure the proportion of patients in the PDO group who achieve their own personal outcome at month 3, assessed by VAS (1-10) to V1.	To measure the proportion of patients in the PDO group who achieve their own personal outcome at month 3, assessed by VAS (1-10) to V1.	at month 3
Secondary outcome. To measure the proportion of patients in the PDO group who achieve their own personal outcome at month 6, assessed by a VAS (1-10) as minimal clinically important difference (MCID) of 1.5 points to V1.	To measure the proportion of patients in the PDO group who achieve their own personal outcome at month 6, assessed by a VAS (1-10) as minimal clinically important difference (MCID) of 1.5 points to V1.	at month 6
Secondary outcome. To measure the proportion of patients in the PDO group who maintain/improve their own personal outcome at month 6, assessed by a VAS (1-10) to V2.	To measure the proportion of patients in the PDO group who maintain/improve their own personal outcome at month 6, assessed by a VAS (1-10) to V2.	at month 6

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): January 15, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 2943

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No