AsthmaMANINCT04796844
MANI Real-life Perspective Observatory
An observational study of Asthma and Mild Asthma, run by Societa Italiana di Pneumologia at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Asthma, Mild Asthma, Moderate Asthma
- How many people
- 20,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2021to Nov 2032
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult patients
- Asthma diagnosis according GINA 2020 algorithm (Annex 1)
- Patients enrolled in other previous or ongoing observational studies
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale Policlinico San Martino
Genova, 16132
Fulvio Braido, +393386036913, fulvio.braido@unige.it
About this study
Official title: Mild/Moderate Asthma Network of Italy 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.
Read the detailed 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).
- Conditions
- Asthma, Mild Asthma, Moderate Asthma
- Keywords
- Asthma, Adult, Cluster, Cohort study, Italy, Prospective
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled
Secondary outcomes (16)
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)
Measured: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled
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
Measured: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled
Burden of OCS in mild and moderate asthma
Burden of oral corticosteroids in mild and moderate asthma (mg/year)
Measured: 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
SABA use in mild and moderate asthma (canisters/year)
Measured: 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
Influence of infections and vaccinations on disease outcomes and progression (rate of progression; questionnaire score)
Measured: 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
Influence of upper airway disease on disease outcomes and progression (rate of progression; questionnaire score)
Measured: 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
Impact of inhalation techniques and smart inhalers on disease outcomes and progression (inhalation error/asthma control score; inhalation error/rate of progression)
Measured: 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
Environmental exposure influences on disease outcome and progression (PM10/rate of progression)
Measured: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled
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)
Measured: 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
Role of smoking and life style in lung function and disease progression (pack year/disease progression)
Measured: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled
Patients reported outcomes over time
Patients reported outcomes over time (score according validated questionnaires)
Measured: 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
Patient awareness and engagement in mild and moderate asthma (questionnaire score)
Measured: 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
Impact of digital therapy on disease management and outcomes (canister/year and dose/year)
Measured: 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
Direct, indirect, and intangible costs of mild and moderate asthma (EU/disease severity)
Measured: 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-efficiency of mild/moderate asthma treatments and management plans (cost/year)
Measured: 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
Sociodemographic issues related to disease progression and burden (age, sex, education, employment/rate of progression)
Measured: through study completion; follow-up procedures will last 10 years from the date of the last patient enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start1 May 2021
- Primary completion1 May 2021
- Study completionNov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Societa Italiana di Pneumologia
- Sponsor type
- University, hospital or other
- Collaborators
- Società Italiana di Allergologia, Asma e Immunologia Clinica
- Responsible party
- Sponsor
- Investigators
- Fulvio Braido, Principal investigator, IRCCS Ospedale Policlinico San Martino, Department of Internal Medicine (DiMI), University of Genoa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796844
- Sponsor's protocol ID
- 456/2020 - DB id 10481
- Other IDs
- MANI Project
- Acronym
- MANI
- Status last verified
- Nov 2023
- First submitted
- 23 Feb 2021
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24337046Braido F, Blasi F, Canonica GW, Paggiaro P, Beghe B, Bonini M, Carpagnano GE, Del Giacco S, Lavorini F, Milanese M, Patella V, Santus P, Contoli M; MANI Network; Allegrini C, Baiardini I, Bonzano L, Caiaffa MF, Castelnuovo P, Corsico AG, Cosmi L, Costantino MT, Cottini M, Crimi N, Crivellaro MA, D'Alo S, Folletti I, Fornari D, Foschino-Barbaro MP, Franceschini L, Gargano D, Oliani KL, Maniscalco M, Melissari L, Montagni M, Montuschi P, Murgia N, Pannofino A, Papi A, Parente R, Pelaia G, Pini L, Puggioni F, Pulera N, Resta O, Ricciardi L, Ridolo E, Savi E, Savoia F, Scala G, Senna G, Tripodi S, Vatrella A, Ventura MT, Viviano VM, Yacoub MR. Mild/Moderate Asthma Network in Italy (MANI): a long-term observational study. J Asthma. 2022 Sep;59(9):1908-1913. doi: 10.1080/02770903.2021.1968895. Epub 2021 Sep 1.
PubMed 34469268
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mild/Moderate Asthma Network of Italy Observatory
- ClinicalTrials.gov ID
- NCT04796844
- Acronym / sponsor ID
- MANI / 456/2020 - DB id 10481
- Conditions
- Asthma, Mild Asthma, Moderate Asthma
- Keywords
- Asthma, Adult, Cluster, Cohort study, Italy, Prospective
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Societa Italiana di PneumologiaUniversity, hospital or other
- Collaborators
- Società Italiana di Allergologia, Asma e Immunologia Clinica
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- Nov 2032 (estimated)
- First posted
- 15 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Adult patients
- Asthma diagnosis according GINA 2020 algorithm (Annex 1)
- Patients enrolled in other previous or ongoing observational studies
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
16 secondary outcomes
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
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
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
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
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 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
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
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
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
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
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Background: PubMed 24337046Chung 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.
- Derived from this study: PubMed 34469268Braido F, Blasi F, Canonica GW, Paggiaro P, Beghe B, Bonini M, Carpagnano GE, Del Giacco S, Lavorini F, Milanese M, Patella V, Santus P, Contoli M; MANI Network; Allegrini C, Baiardini I, Bonzano L, Caiaffa MF, Castelnuovo P, Corsico AG, Cosmi L, Costantino MT, Cottini M, Crimi N, Crivellaro MA, D'Alo S, Folletti I, Fornari D, Foschino-Barbaro MP, Franceschini L, Gargano D, Oliani KL, Maniscalco M, Melissari L, Montagni M, Montuschi P, Murgia N, Pannofino A, Papi A, Parente R, Pelaia G, Pini L, Puggioni F, Pulera N, Resta O, Ricciardi L, Ridolo E, Savi E, Savoia F, Scala G, Senna G, Tripodi S, Vatrella A, Ventura MT, Viviano VM, Yacoub MR. Mild/Moderate Asthma Network in Italy (MANI): a long-term observational study. J Asthma. 2022 Sep;59(9):1908-1913. doi: 10.1080/02770903.2021.1968895. Epub 2021 Sep 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fulvio Braido principal investigator
IRCCS Ospedale Policlinico San Martino, Department of Internal Medicine (DiMI), University of Genoa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Mild Asthma, run by Societa Italiana di Pneumologia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fulvio Braido (+ 393386036913, fulvio.braido@unige.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04796844, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.