MANI Real-life Perspective Observatory

Study Overview
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Brief Summary
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The purpose of this registry aims is to collect a large number of patients with mild and moderate asthma in a real-word conditions for a perspective observation of epidemiological evolution of the disease in relation to the therapeutic interventions available currently and in the near future.

Detailed Description
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To represent real-world mild moderate Italian asthmatics, all adults with diagnosed asthma by specialist, according GINA (Global Initiative for Asthma) document, attending respiratory or allergy clinic for a scheduled visit are eligible for study enrollment. If inclusion/exclusion criteria are satisfied, a written consent to participate in the study will be obtained and an informative leaflet for the patient and his/her general practitioners will be delivered. Subjects follow up will be scheduled according with GINA document and center plan (6 or 12 months follow up visit).

Official Title
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Mild/Moderate Asthma Network of Italy Observatory

Conditions
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Asthma, Mild Asthma, Moderate Asthma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients Asthma diagnosis according GINA 2020 algorithm (Annex 1) Patients enrolled in other previous or ongoing observational studies Exclusion Criteria: Severe asthma patients according International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. [Chung KF et al. European Respiratory Journal Feb 2014, 43 (2) 343-373; DOI: 10.1183/09031936.00202013 (Annex 2)] Subjects are excluded from this cohort if they exhibit interstitial lung diseases, pulmonary neoplasms, current lung infections, immunological disorders leading to the use of immunosuppressants or continuous treatment with oral steroids.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A cluster-based, real world, cross-sectional perspective, observational cohort study | Perspective observation of epidemiological evolution of mild and moderate asthma (rate of asthmatic patients transitioned to a more severe stage according Global Initiative for Asthma [GINA] document) | through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Real life assessment of control, exacerbation and PROs in patients treated with different drugs and schedule | Real-life assessment of asthma control over time (Asthma Control Test and Asthma Control Questionnaire scores), exacerbation rate over time (n/year) and patient-reported outcomes (e.g., quality of life, patient engagement, disease awareness) from groups treated with different drugs and schedules (questionnaire score) | through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled | 
| Asthma control in pregnant women | Asthma control in pregnant women by means of a specific application for android- and iOS-based smartphones, in comparison with the traditional current management | through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled | 
| Burden of OCS in mild and moderate asthma | Burden of oral corticosteroids in mild and moderate asthma (mg/year) | through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled | 
| SABA use in mild and moderate asthma | SABA use in mild and moderate asthma (canisters/year) | through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled | 
| Influence of infections and vaccinations on disease outcomes and progression | Influence of infections and vaccinations on disease outcomes and progression (rate of progression; questionnaire score) | through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled | 
| Influence of upper airway disease on disease outcomes and progression | Influence of upper airway disease on disease outcomes and progression (rate of progression; questionnaire score) | through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled | 
| Impact of inhalation techniques and smart inhalers on disease outcomes and progression | Impact of inhalation techniques and smart inhalers on disease outcomes and progression (inhalation error/asthma control score; inhalation error/rate of progression) | through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled | 
| Environmental exposure influences on disease outcome and progression | Environmental exposure influences on disease outcome and progression (PM10/rate of progression) | through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled | 
| Evolution of inflammatory patterns over time | Evolution of inflammatory patterns over time and their relationships to disease outcomes and progression (published biomarker value/asthma control; published biomarker value/rate of progression) | through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled | 
| Role of smoking and life style in lung function and disease progression | Role of smoking and life style in lung function and disease progression (pack year/disease progression) | through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled | 
| Patients reported outcomes over time | Patients reported outcomes over time (score according validated questionnaires) | through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled | 
| Patient awareness and engagement in mild and moderate asthma | Patient awareness and engagement in mild and moderate asthma (questionnaire score) | through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled | 
| Impact of digital therapy on disease management and outcomes | Impact of digital therapy on disease management and outcomes (canister/year and dose/year) | through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled | 
| Direct, indirect, and intangible costs of mild and moderate asthma | Direct, indirect, and intangible costs of mild and moderate asthma (EU/disease severity) | through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled | 
| Cost-efficiency of mild/moderate asthma treatments and management plans | Cost-efficiency of mild/moderate asthma treatments and management plans (cost/year) | through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled | 
| Sociodemographic issues related to disease progression and burden | Sociodemographic issues related to disease progression and burden (age, sex, education, employment/rate of progression) | through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Adult, Cluster, Cohort study, Italy, Prospective