MANI Real-life Perspective Observatory

Recruiting

• Conditions: Asthma; Mild Asthma; Moderate Asthma

• Registration Number: NCT04796844
• Lead Sponsor: Societa Italiana di Pneumologia

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-03-09
• Study First Posted: 2021-03-15
• Study Start: 2021-05-01
• Primary Completion: 2021-05-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-28
• Study Completion: 2032-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A cluster-based, real world, cross-sectional perspective, observational cohort study	through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

IRCCS Ospedale Policlinico San Martino; 🇮🇹 Genova, Italy