AsthmaPRISMANCT01110460
Prospective Study on Asthma Control
An observational study of Asthma, run by Chiesi Farmaceutici S.p.A..
Trial summary
Accordingly, the new update of the Global Initiative for Asthma (GINA) guidelines 2006 is based on the control of the disease and attempts to quantify and graduate the level of control by using a classification of asthmatic subjects into controlled,partly controlled and uncontrolled groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- How many people
- 2,875 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Nov 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Asthmatic patients
Who may be able to join
- Written informed consent obtained
- Male or female patients with asthma diagnosis (at least 6 months)
- ability to understand and fill in questionaires
Who cannot join
- Patients included in a clinical trial within the last 12 weeks
- Patients with serious illnesses
- Pregnant women
About this study
Official title: Cross-sectional and Prospective Observational Study Aimed to Assess the Prevalence of Uncontrolled and Partially Controlled Asthmatics in Italy and the Prevalence of Uncontrolled/Partially Controlled Patients Achieved Asthma Control After 12 Months
Accordingly, the new update of the Global Initiative for Asthma (GINA) guidelines 2006 is based on the control of the disease and attempts to quantify and graduate the level of control by using a classification of asthmatic subjects into controlled,partly controlled and uncontrolled groups.
Achieving and maintaining optimal asthma control is a major goal of asthma management. Although the results of clinical trials advocate that asthma control can be reached in most patients, there is evidence that many subjects with asthma have poorly controlled disease and that there is a significant gap between the treatment goals and the current level of asthma control achieved in the general population.
The aim of this study is to assess the prevalence of uncontrolled and partly controlled asthma in Italy using a patient-based tool such as Asthma Control Test.
- Conditions
- Asthma
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma control test score
Measured: 3 months
Secondary outcomes (1)
EuroQoL test score
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2010 (estimated)
- Study startJan 2009
- Primary completionOct 2009
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- 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
- 2,875 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medidata Solutions
- Responsible party
- Sponsor
- Investigators
- Claudio Terzano, Study director, Policlinico Umberto I Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110460
- Sponsor's protocol ID
- PRISMA
- Acronym
- PRISMA
- Status last verified
- Feb 2025
- First submitted
- 23 Apr 2010
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Terzano C, Cremonesi G, Girbino G, Ingrassia E, Marsico S, Nicolini G, Allegra L; PRISMA (PRospectIve Study on asthMA control) Study Group. 1-year prospective real life monitoring of asthma control and quality of life in Italy. Respir Res. 2012 Dec 6;13(1):112. doi: 10.1186/1465-9921-13-112.
PubMed 23216798
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional and Prospective Observational Study Aimed to Assess the Prevalence of Uncontrolled and Partially Controlled Asthmatics in Italy and the Prevalence of Uncontrolled/Partially Controlled Patients Achieved Asthma Control After 12 Months
- ClinicalTrials.gov ID
- NCT01110460
- Acronym / sponsor ID
- PRISMA / PRISMA
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,875 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Collaborators
- Medidata Solutions
- Study start
- Jan 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 26 Apr 2010 (estimated)
- 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.
Accordingly, the new update of the Global Initiative for Asthma (GINA) guidelines 2006 is based on the control of the disease and attempts to quantify and graduate the level of control by using a classification of asthmatic subjects into controlled,partly controlled and uncontrolled groups.
Achieving and maintaining optimal asthma control is a major goal of asthma management. Although the results of clinical trials advocate that asthma control can be reached in most patients, there is evidence that many subjects with asthma have poorly controlled disease and that there is a significant gap between the treatment goals and the current level of asthma control achieved in the general population.
The aim of this study is to assess the prevalence of uncontrolled and partly controlled asthma in Italy using a patient-based tool such as Asthma Control Test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Asthmatic patients
Key inclusion criteria (3 listed)
- Written informed consent obtained
- Male or female patients with asthma diagnosis (at least 6 months)
- ability to understand and fill in questionaires
Key exclusion criteria (3 listed)
- Patients included in a clinical trial within the last 12 weeks
- Patients with serious illnesses
- Pregnant women
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
Asthma control test score
Time frame: 3 months
1 secondary outcome
EuroQoL test score
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Derived from this study: PubMed 23216798Terzano C, Cremonesi G, Girbino G, Ingrassia E, Marsico S, Nicolini G, Allegra L; PRISMA (PRospectIve Study on asthMA control) Study Group. 1-year prospective real life monitoring of asthma control and quality of life in Italy. Respir Res. 2012 Dec 6;13(1):112. doi: 10.1186/1465-9921-13-112.
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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. This study is not recruiting at the moment.
Claudio Terzano study director
Policlinico Umberto I Roma
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Chiesi Farmaceutici S.p.A..
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 3 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: finished, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma control test score (time frame: 3 months). 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 NCT01110460, which also lists 1 linked publication.
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 18 Feb 2025; AzTrials last refreshed its copy on 30 Oct 2026.