MANI Real-life Perspective Observatory
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorSocieta Italiana di Pneumologia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients
Asthma diagnosis according GINA 2020 algorithm (Annex 1)
Patients enrolled in other previous or ongoing observational studies
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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)
Time frame
through study completion; follow-up procedures will last 10 years from the date of the last patient enrolledSecondary outcomes
1
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)
Time frame
through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled2
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
Time frame
through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled3
Burden of OCS in mild and moderate asthma
Burden of oral corticosteroids in mild and moderate asthma (mg/year)
Time frame
through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled4
SABA use in mild and moderate asthma
SABA use in mild and moderate asthma (canisters/year)
Time frame
through study completion; follow-up procedures will last 10 years from the date of the last patient enrolledSponsors and contacts
Click on the lead sponsor to view all of their trials.
Societa Italiana di Pneumologia
Lead sponsor
Società Italiana di Allergologia, Asma e Immunologia Clinica
Collaborator
Source ClinicalTrials.gov