MANI Real-life Perspective Observatory

Societa Italiana di Pneumologia20,000 enrolled

Overview

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.

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).

Study Type

OBSERVATIONAL

Enrollment

20,000

Conditions

Asthma Mild Asthma Moderate Asthma

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (1)

IRCCS Ospedale Policlinico San Martino

Genova, Italy

RECRUITING

Outcomes

Primary Outcomes

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)

Time frame: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled

Secondary Outcomes

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)

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled

Central Contacts

Fulvio Braido

CONTACT

+ 393386036913 fulvio.braido@unige.it

Data from ClinicalTrials.gov

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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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled