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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personal approach on asthma control (PDO group) | Experimental |
| |
| Non-personalized approach (UC group) | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PDO Group | Other | Patients in the intervention gruop with set a personalized outcome within a usual asthma review consultation |
|
| 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). |
| 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; |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco Blasi, Prof. | Contact | +390250320627 | francesco.blasi@unimi.it | |
| Maura Spotti, PhD | Contact | +393336216405 | maura.spotti@policlinico.mi.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASST Papa Giovanni XXIII | Recruiting | Bergamo | 24127 | Italy |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 20, 2026 | |
| Reset | Feb 4, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 20, 2026 | Feb 4, 2026 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| 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 |
| Azienda ospedaliera Spedali Civili di Brescia | Recruiting | Brescia | 25123 | Italy |
|
| Ospedale San Martino di Genova | Recruiting | Genova | 16132 | Italy |
|
| ASST Fate Bene e Fratelli Sacco | Recruiting | Milan | 20100 | Italy |
|
| ASST Grande Ospedale Metropolitano Niguarda | Not yet recruiting | Milan | 20100 | Italy |
|
| ASST Santi Paolo e Carlo | Recruiting | Milan | 20100 | Italy |
|
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano | Recruiting | Milan | 20122 | Italy |
|
| Policlinico San Matteo | Recruiting | Pavia | 27100 | Italy |
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| Ospedale di Rovigo | Recruiting | Rovigo | 45100 | Italy |
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| Humanitas Hospital - UO Allergologia | Recruiting | Rozzano | 20089 | Italy |
|
| Humanitas Hospital - UO Pneumologia | Not yet recruiting | Rozzano | 20089 | Italy |
|
| Istituti Clinici Scientifici Maugeri, IRCCS Tradate | Recruiting | Tradate | 21049 | Italy |
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |