MANI Real-life Perspective Observatory (MANI)

Mild/Moderate Asthma Network of Italy Observatory

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma; Moderate Asthma; Mild Asthma

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 Type: Observational
• Enrollment (Estimated): 20000

Contacts and Locations

• Study Contact: Name: Fulvio Braido; Phone Number: + 393386036913; Email: fulvio.braido@unige.it

Study Locations

• Italy
  • Genova, Italy, 16132
    • Recruiting
    • IRCCS Ospedale Policlinico San Martino
    • Contact: Fulvio Braido; Phone Number: +393386036913; Email: fulvio.braido@unige.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

To represent real-world mild moderate Italian asthmatics, all adults with diagnosed asthma by specialist, according GINA 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 GPs will be delivered.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Societa Italiana di Pneumologia
• Collaborators: Società Italiana di Allergologia, Asma e Immunologia Clinica
• Investigators: Principal Investigator: Fulvio Braido, IRCCS Ospedale Policlinico San Martino, Department of Internal Medicine (DiMI), University of Genoa

Publications and helpful links

General Publications

• Chung KF, Wenzel SE, Brozek JL, Bush A, Castro M, Sterk PJ, Adcock IM, Bateman ED, Bel EH, Bleecker ER, Boulet LP, Brightling C, Chanez P, Dahlen SE, Djukanovic R, Frey U, Gaga M, Gibson P, Hamid Q, Jajour NN, Mauad T, Sorkness RL, Teague WG. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014 Feb;43(2):343-73. doi: 10.1183/09031936.00202013. Epub 2013 Dec 12. Erratum In: Eur Respir J. 2014 Apr;43(4):1216. Dosage error in article text. Eur Respir J. 2018 Jul 27;52(1): Eur Respir J. 2022 Jun 9;59(6):
• Braido F, Blasi F, Canonica GW, Paggiaro P, Beghe B, Bonini M, Carpagnano GE, Del Giacco S, Lavorini F, Milanese M, Patella V, Santus P, Contoli M; MANI Network; Allegrini C, Baiardini I, Bonzano L, Caiaffa MF, Castelnuovo P, Corsico AG, Cosmi L, Costantino MT, Cottini M, Crimi N, Crivellaro MA, D'Alo S, Folletti I, Fornari D, Foschino-Barbaro MP, Franceschini L, Gargano D, Oliani KL, Maniscalco M, Melissari L, Montagni M, Montuschi P, Murgia N, Pannofino A, Papi A, Parente R, Pelaia G, Pini L, Puggioni F, Pulera N, Resta O, Ricciardi L, Ridolo E, Savi E, Savoia F, Scala G, Senna G, Tripodi S, Vatrella A, Ventura MT, Viviano VM, Yacoub MR. Mild/Moderate Asthma Network in Italy (MANI): a long-term observational study. J Asthma. 2022 Sep;59(9):1908-1913. doi: 10.1080/02770903.2021.1968895. Epub 2021 Sep 1.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): May 1, 2021
• Study Completion (Estimated): November 1, 2032

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: March 9, 2021
• First Posted (Actual): March 15, 2021

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 22, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Cohort study; Asthma; Adult; Cluster; Prospective; Italy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 456/2020 - DB id 10481; MANI Project (Other Identifier: SIP/IRS and SIAAIC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No