Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1736 participants
OBSERVATIONAL
2023-11-07
2025-07-17
Brief Summary
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Detailed Description
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Investigators from 4 different institutions will be involved:
FIMMG (Federazione Italiana dei Medici di Medicina Generale). Ten general practitioners will recruit approx. 1000 consecutive subjects from the general population.
SIAAIC (Societa' Italiana di Allergologia, Asma e Immunologia Clkinica). Ten allergy specialists will recruit approx.1000 consecutive subjects suffering from allergic diseases.
Fondazione Maugeri (5 Centers) and UCSC (Universita' Cattolica del Sacro Cuore) / Policlinico Gemelli will recruit approx. 750 consecutive subjects suffering from asthma or COPD.
Participants having signed an informed consent at any suspected Respiratory Tract Infection (RTI) during the observation period will be asked to contact (phone call or visit) the investigator to record the relevant clinical information documenting the RTI episode.
At the end of the observation period all subjects will be contacted by the investigators to check for completeness and compliance of the RTI reporting.
The procedure will be repeated in the same way in the second year of survey but including subjects having experienced at least one confirmed RTI during the first year. This will allow assessing intra-individual variability of infectious episodes from year to year.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort Incidence
This cohort will comprise subjects recruited from 1st November 2023 to 21st December 2023 and followed from 22nd December 2023 to 30th April 2024 and subjects recruited from 01st November 2024 to 21st December 2024 and followed from 22nd Dec 2024 to 30th April 2025. During the follow-up period, the subjects will be asked to report respiratory tract infections to the investigators (phone calls or study visit).
No intervention
no difference: both cohorts are followed in the same way
Cohort Respiratory Tract Infections (RTI) positive
Subjects recruited from 1st November 2023 to 21st December 2023, followed from 22nd December 2023 to 30th April 2024 and who developed at least one respiratory tract infection will be also followed from 22nd December 2024 to 30th April 2025 and asked to report respiratory tract infections to the investigators.
No intervention
no difference: both cohorts are followed in the same way
Interventions
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No intervention
no difference: both cohorts are followed in the same way
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Istituto di Farmacologia Traslazionale - National Research Council (IFT-CNR)
UNKNOWN
Lallemand Pharma AG
INDUSTRY
Responsible Party
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Principal Investigators
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Sergio Bonini, Professor
Role: PRINCIPAL_INVESTIGATOR
Institute of Translational Pharmacology, Italian National Research Council (IFT-CNR)
Locations
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Dr F Pugliese
Bari, , Italy
Università degli Studi di Cagliari
Cagliari, , Italy
Università degli studi di salerno
Fisciano, , Italy
Azienda Ospedaliero-Universitaria Careggi
Florence, , Italy
Dr M D'Onofrio
Napoli, , Italy
Azienda Ospedale Università Padova
Padua, , Italy
Azienda Ospedale-Università Padova
Padua, , Italy
Dr F Gatti
Parma, , Italy
A.S.L. di Pescara - Abruzzo
Popoli, , Italy
Dr F R Amorosi
Roma, , Italy
Dr G Marrocco
Roma, , Italy
Dr S Narzisi
Roma, , Italy
Dr A Galli
Roma, , Italy
Dr C Governale
Roma, , Italy
Dr E Meco
Roma, , Italy
Dr A M Pistuddi
Roma, , Italy
Dr R Chini
Roma, , Italy
Università Cattolica del Sacro Cuore
Roma, , Italy
Dr G Biondi
Roma, , Italy
Dr C Nicoletta
Salerno, , Italy
Azienda Ospedaliera Mauriziano di Torino
Torino, , Italy
ASST dei Sette Laghi
Varese, , Italy
ASP Vibo Valentia
Vibo Valentia, , Italy
Countries
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Other Identifiers
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2023/09/01
Identifier Type: -
Identifier Source: org_study_id
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