Prospective Study on Asthma Control

Asthma Clinical Trial

— PRISMA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01110460
• Other study ID #: PRISMA
• Status: Completed
• Phase: N/A
• First received: April 23, 2010
• Last updated: January 31, 2011
• Start date: January 2009
• Est. completion date: November 2010

Study information

• Verified date: January 2011
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2875
• Est. completion date: November 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Written informed consent obtained

• Male or female patients with asthma diagnosis (at least 6 months)

• ability to understand and fill in questionaires

Exclusion Criteria:

• Patients included in a clinical trial within the last 12 weeks

• Patients with serious illnesses

• Pregnant women

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.	Medidata Solutions

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma control test score		3 months	No
Secondary	EuroQoL test score		3 months	No