Clinical trial NCT04796844: MANI Real-life Perspective Observatory
Official title: Mild/Moderate Asthma Network of Italy Observatory
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Asthma
Mild Asthma
Moderate Asthma
Keywords: Asthma
Adult
Cluster
Cohort study
Italy
Prospective
Lead sponsor: Societa Italiana di Pneumologia
Sponsor class: OTHER
Collaborators: name: Società Italiana di Allergologia, Asma e Immunologia Clinica
First posted: 2021-03-15
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

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.

Primary outcomes:
measure: A cluster-based, real world, cross-sectional perspective, observational cohort study
timeFrame: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled
Secondary outcomes:
measure: Real life assessment of control, exacerbation and PROs in patients treated with different drugs and schedule
timeFrame: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled
measure: Asthma control in pregnant women
timeFrame: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled
measure: Burden of OCS in mild and moderate asthma
timeFrame: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled
measure: SABA use in mild and moderate asthma
timeFrame: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled
measure: Influence of infections and vaccinations on disease outcomes and progression
timeFrame: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled
measure: Influence of upper airway disease on disease outcomes and progression
timeFrame: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled
measure: Impact of inhalation techniques and smart inhalers on disease outcomes and progression
timeFrame: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled
measure: Environmental exposure influences on disease outcome and progression
timeFrame: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled
measure: Evolution of inflammatory patterns over time
timeFrame: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled
measure: Role of smoking and life style in lung function and disease progression
timeFrame: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled
measure: Patients reported outcomes over time
timeFrame: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled
measure: Patient awareness and engagement in mild and moderate asthma
timeFrame: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled
measure: Impact of digital therapy on disease management and outcomes
timeFrame: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled
measure: Direct, indirect, and intangible costs of mild and moderate asthma
timeFrame: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled
measure: Cost-efficiency of mild/moderate asthma treatments and management plans
timeFrame: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled
measure: Sociodemographic issues related to disease progression and burden
timeFrame: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled
Other outcomes:
Locations:
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
Study officials:
affiliation: IRCCS Ospedale Policlinico San Martino, Department of Internal Medicine (DiMI), University of Genoa
name: Fulvio Braido
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.