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MANI Real-life Perspective Observatory (MANI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04796844
Recruitment Status : Recruiting
First Posted : March 15, 2021
Last Update Posted : February 8, 2022
Sponsor:
Collaborator:
Società Italiana di Allergologia, Asma e Immunologia Clinica
Information provided by (Responsible Party):
Societa Italiana di Pneumologia

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.

Condition or disease
Asthma Mild Asthma Moderate Asthma

Detailed Description:

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.

Subjects follow up will be scheduled according with GINA document and center plan (6 or 12 months follow up visit).

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 20000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Mild/Moderate Asthma Network of Italy Observatory
Actual Study Start Date : May 1, 2021
Actual Primary Completion Date : May 1, 2021
Estimated Study Completion Date : November 2032

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma




Primary Outcome Measures :
  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 Outcome Measures :
  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)


Biospecimen Retention:   Samples With DNA

The information collected in the CRF coincides with the patient data routinely reported in the medical record.

In case of a blood draw for routine clinical practice, a blood sample will be acquired and stored to assess biomarkers currently under investigation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04796844


Contacts
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Contact: Fulvio Braido + 393386036913 fulvio.braido@unige.it

Locations
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Italy
IRCCS Ospedale Policlinico San Martino Recruiting
Genova, Italy, 16132
Contact: Fulvio Braido    +393386036913    fulvio.braido@unige.it   
Sponsors and Collaborators
Societa Italiana di Pneumologia
Società Italiana di Allergologia, Asma e Immunologia Clinica
Investigators
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Principal Investigator: Fulvio Braido IRCCS Ospedale Policlinico San Martino, Department of Internal Medicine (DiMI), University of Genoa
  Study Documents (Full-Text)

Documents provided by Societa Italiana di Pneumologia:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Societa Italiana di Pneumologia
ClinicalTrials.gov Identifier: NCT04796844    
Other Study ID Numbers: 456/2020 - DB id 10481
MANI Project ( Other Identifier: SIP/IRS and SIAAIC )
First Posted: March 15, 2021    Key Record Dates
Last Update Posted: February 8, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Societa Italiana di Pneumologia:
Asthma
Adult
Cluster
Cohort study
Italy
Prospective
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases