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| ID | Type | Description | Link |
|---|---|---|---|
| MANI Project | Other Identifier | SIP/IRS and SIAAIC |
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| Name | Class |
|---|---|
| Società Italiana di Allergologia, Asma e Immunologia Clinica | OTHER |
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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.
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).
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fulvio Braido | Contact | + 393386036913 | fulvio.braido@unige.it |
| Name | Affiliation | Role |
|---|---|---|
| Fulvio Braido | IRCCS Ospedale Policlinico San Martino, Department of Internal Medicine (DiMI), University of Genoa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Ospedale Policlinico San Martino | Recruiting | Genova | 16132 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24337046 | Background | 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. | |
| 34469268 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 30, 2020 | Nov 25, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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The information collected in the CRF coincides with the patient data routinely reported in the medical record.
In case of a blood draw for routine clinical practice, a blood sample will be acquired and stored to assess biomarkers currently under investigation.
| 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 |
| Derived |
| 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. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |