MANI Real-life Perspective Observatory

Asthma Clinical Trial

— MANI  

Official title:

Mild/Moderate Asthma Network of Italy Observatory

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04796844
• Other study ID #: 456/2020 - DB id 10481
• Secondary ID: MANI Project
• Status: Recruiting
• Start date: May 1, 2021
• Est. completion date: November 2032

Study information

• Verified date: November 2023
• Source: Societa Italiana di Pneumologia
• Contact: Fulvio Braido
• Phone: + 393386036913
• Email: fulvio.braido[@]unige.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: November 2032
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Mild Asthma
• Moderate Asthma

Locations

Country	Name	City	State
Italy	IRCCS Ospedale Policlinico San Martino	Genova

Sponsors (2)

Lead Sponsor	Collaborator
Societa Italiana di Pneumologia	Società Italiana di Allergologia, Asma e Immunologia Clinica

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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