MANI Real-life Perspective Observatory

NCT04796844 | Recruiting

• 2 other identifiers: 456/2020 - DB id 10481MANI Project
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Mild Asthma; Moderate Asthma

Keywords

Asthma; Adult; Cluster; Cohort study; Italy; Prospective

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• 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

• Asthma control in pregnant women

  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

  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

  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

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adult patients
• Asthma diagnosis according GINA 2020 algorithm (Annex 1)
• Patients enrolled in other previous or ongoing observational studies

You may not qualify if:

• 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.

Sponsors & Collaborators

• Societa Italiana di Pneumologia: lead
• Società Italiana di Allergologia, Asma e Immunologia Clinica: collaborator

Study Sites (1)

IRCCS Ospedale Policlinico San Martino

Genova, 16132, Italy

RECRUITING

Related Publications (2)

• 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.

  PMID: 24337046 BACKGROUND

• 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.

  PMID: 34469268 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Fulvio Braido

  IRCCS Ospedale Policlinico San Martino, Department of Internal Medicine (DiMI), University of Genoa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fulvio Braido

CONTACT

+ 393386036913; fulvio.braido@unige.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 15, 2021
• Study Start: May 1, 2021
• Primary Completion: May 1, 2021
• Study Completion (Estimated): November 1, 2032
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

IT (1)