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NCT Number: NCT04796844

MANI Real-life Perspective Observatory

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Mild Asthma Moderate Asthma Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Ospedale Policlinico San Martino

Genova, 16132, Italy

Location status: Recruiting

Location contact

Fulvio Braido

CONTACT

[email protected]

+393386036913

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. A cluster-based, real world, cross-sectional perspective, observational cohort study

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

    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)

Secondary outcomes

  1. Real life assessment of control, exacerbation and PROs in patients treated with different drugs and schedule

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

    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)

  2. Asthma control in pregnant women

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

    Asthma control in pregnant women by means of a specific application for android- and iOS-based smartphones, in comparison with the traditional current management

  3. Burden of OCS in mild and moderate asthma

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

    Burden of oral corticosteroids in mild and moderate asthma (mg/year)

  4. SABA use in mild and moderate asthma

    Time frame: 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 (canisters/year)

  5. Influence of infections and vaccinations on disease outcomes and progression

    Time frame: 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 (rate of progression; questionnaire score)

  6. Influence of upper airway disease on disease outcomes and progression

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

    Influence of upper airway disease on disease outcomes and progression (rate of progression; questionnaire score)

  7. Impact of inhalation techniques and smart inhalers on disease outcomes and progression

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

    Impact of inhalation techniques and smart inhalers on disease outcomes and progression (inhalation error/asthma control score; inhalation error/rate of progression)

  8. Environmental exposure influences on disease outcome and progression

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

    Environmental exposure influences on disease outcome and progression (PM10/rate of progression)

  9. Evolution of inflammatory patterns over time

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

    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)

  10. Role of smoking and life style in lung function and disease progression

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

    Role of smoking and life style in lung function and disease progression (pack year/disease progression)

  11. Patients reported outcomes over time

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

    Patients reported outcomes over time (score according validated questionnaires)

  12. Patient awareness and engagement in mild and moderate asthma

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

    Patient awareness and engagement in mild and moderate asthma (questionnaire score)

  13. Impact of digital therapy on disease management and outcomes

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

    Impact of digital therapy on disease management and outcomes (canister/year and dose/year)

  14. Direct, indirect, and intangible costs of mild and moderate asthma

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

    Direct, indirect, and intangible costs of mild and moderate asthma (EU/disease severity)

  15. Cost-efficiency of mild/moderate asthma treatments and management plans

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

    Cost-efficiency of mild/moderate asthma treatments and management plans (cost/year)

  16. Sociodemographic issues related to disease progression and burden

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

    Sociodemographic issues related to disease progression and burden (age, sex, education, employment/rate of progression)

Study contacts

Contact information is provided by the study sponsor or research team.

Fulvio Braido

CONTACT

[email protected]

+ 393386036913

Sponsors and collaborators

Lead sponsor

Societa Italiana di Pneumologia

Other

Collaborators

  • Società Italiana di Allergologia, Asma e Immunologia Clinica

Registry information

Official study title

Mild/Moderate Asthma Network of Italy Observatory

Acronym: MANI

Important dates

Study start
2021
Primary completion
2021
Study completion
2032
First posted
Mar 15, 2021
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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