MANI Real-life Perspective Observatory
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Asthma, Mild Asthma, Moderate Asthma. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Mild/Moderate Asthma Network of Italy Observatory
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.
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).
Primary outcome measures
- A cluster-based, real world, cross-sectional perspective, observational cohort study [Time frame: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled]
Secondary outcome measures (12)
- Real life assessment of control, exacerbation and PROs in patients treated with different drugs and schedule [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 [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 [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 [Time frame: 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 [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 [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 [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 [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 [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 [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 [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 [Time frame: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Ospedale Policlinico San Martino — Genova
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: 10.1183/09031936.0020201 PMID 24337046
- 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 PMID 34469268
Identifiers
NCT: NCT04796844 · 456/2020 - DB id 10481 · MANI Project