Bronchial AsthmaPERSONASNCT06320119
Setting a PERSONalized Outcome in ASthma: the PERSONAS Study. A Patient Driven Outcome (PDO) Study
A study testing PDO Group in people with Bronchial Asthma, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 12 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- PDO Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 12 sitesItaly
- Study dates
- 1 Jan 2023to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged ≥18 years;
- Patients with a documented diagnosis of mild/moderate asthma, according to GINA, for at least 6 months before visit 1;
- Patients on LABA/ICS chronic inhaled treatment (> 4 weeks before visit 1);
- ACT values <20 points
- No smoking patients, or former smokers (at least 1 year since quitting smoking, and no more than 10 pack/year, according the WHO definition);
- Patients able to set up a personal outcome according to the protocol instruction, and willing to improve their personal outcome;
- Patients able to understand written and spoken Italian;
- Patients who give their informed consent to participate in the study.
Who cannot join
- Patients treated with oral corticosteroids (OCS) and/or biological for severe refractory asthma;
- Patients treated with OCS for any other chronic disease;
- 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;
- 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.
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Italy12 sites, 12 recruiting
- Recruiting
ASST Papa Giovanni XXIII
Bergamo, 24127
Fabiano Di Marco, Prof.
- Recruiting
Azienda ospedaliera Spedali Civili di Brescia
Brescia, 25123
Laura Pini, Prof.
- Recruiting
Ospedale San Martino di Genova
Genova, 16132
Fulvio Braido, Prof.
- Recruiting
ASST Fate Bene e Fratelli Sacco
Milan, 20100
Pierachille Santus
- Not yet recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20100
Paolo Tarsia, Prof.
- Recruiting
ASST Santi Paolo e Carlo
Milan, 20100
Stefano Centanni, Prof.
- Recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano
Milan, 20122
Francesco Blasi, Prof., +390250320627, francesco.blasi@unimi.it
- Recruiting
Policlinico San Matteo
Pavia, 27100
Angelo Corsico, Prof.
- Recruiting
Ospedale di Rovigo
Rovigo, 45100
Gianluca Casoni, Dott.
- Recruiting
Humanitas Hospital - UO Allergologia
Rozzano, 20089
Enrico Heffler
- Not yet recruiting
Humanitas Hospital - UO Pneumologia
Rozzano, 20089
Stefano Aliberti, Prof.
- Recruiting
Istituti Clinici Scientifici Maugeri, IRCCS Tradate
Tradate, 21049
Antonio Spanevello, Prof.
About this study
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.
- Conditions
- Bronchial Asthma
- Being tested
- PDO Group
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDO GroupOther
Patients in the intervention gruop with set a personalized outcome within a usual asthma review consultation
| Study group | Role | What they receive |
|---|---|---|
| Personal approach on asthma control (PDO group) | Experimental | Not described Receives: Other: PDO Group |
| Non-personalized approach (UC group) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Primary outcome will be measured at month 3 by asthma control test (ACT).
Secondary outcomes (8)
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;
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start1 Jan 2023
- Primary completion15 Jan 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320119
- Sponsor's protocol ID
- 2943
- Acronym
- PERSONAS
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Setting a PERSONalized Outcome in ASthma: the PERSONAS Study. A Patient Driven Outcome (PDO) Study
- ClinicalTrials.gov ID
- NCT06320119
- Acronym / sponsor ID
- PERSONAS / 2943
- Conditions
- Bronchial Asthma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personal approach on asthma control (PDO group) | Experimental | Other: PDO Group |
| Non-personalized approach (UC group) | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female patients aged ≥18 years;
- Patients with a documented diagnosis of mild/moderate asthma, according to GINA, for at least 6 months before visit 1;
- Patients on LABA/ICS chronic inhaled treatment (> 4 weeks before visit 1);
- ACT values <20 points
- No smoking patients, or former smokers (at least 1 year since quitting smoking, and no more than 10 pack/year, according the WHO definition);
Key exclusion criteria (5 listed)
- Patients treated with oral corticosteroids (OCS) and/or biological for severe refractory asthma;
- Patients treated with OCS for any other chronic disease;
- 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;
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PDO GroupPatients in the intervention gruop with set a personalized outcome within a usual asthma review consultation | Other | Personal approach on asthma control (PDO group) |
Primary outcome
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).
Time frame: Primary outcome will be measured at month 3 by asthma control test (ACT).
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).
8 secondary outcomes
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: at month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PDO Group in people with Bronchial Asthma, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 12 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Blasi, Prof. (+390250320627, francesco.blasi@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: Primary outcome will be measured at month 3 by asthma control test (ACT).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.