Prospective Study on Asthma Control
PRISMA
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
1 other identifier
observational
2,875
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2009
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 23, 2010
CompletedFirst Posted
Study publicly available on registry
April 26, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedFebruary 18, 2025
February 1, 2025
9 months
April 23, 2010
February 14, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Asthma control test score
3 months
Secondary Outcomes (1)
EuroQoL test score
3 months
Eligibility Criteria
Asthmatic patients
You may qualify if:
- Written informed consent obtained
- Male or female patients with asthma diagnosis (at least 6 months)
- ability to understand and fill in questionaires
You may not qualify if:
- Patients included in a clinical trial within the last 12 weeks
- Patients with serious illnesses
- Pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chiesi Farmaceutici S.p.A.lead
- Medidata Solutionscollaborator
Related Publications (1)
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.
PMID: 23216798DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Claudio Terzano
Policlinico Umberto I Roma
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2010
First Posted
April 26, 2010
Study Start
January 1, 2009
Primary Completion
October 1, 2009
Study Completion
November 1, 2010
Last Updated
February 18, 2025
Record last verified: 2025-02