Prospective Study on Asthma Control (PRISMA)

This study has been completed.
Sponsor:
Collaborator:
Medidata Solutions
Information provided by:
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT01110460
First received: April 23, 2010
Last updated: January 31, 2011
Last verified: January 2011

April 23, 2010
January 31, 2011
January 2009
October 2009   (final data collection date for primary outcome measure)
Asthma control test score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01110460 on ClinicalTrials.gov Archive Site
EuroQoL test score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Prospective Study on Asthma Control
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Probability Sample

Asthmatic patients

Asthma
Not Provided
Not Provided
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;13:112. doi: 10.1186/1465-9921-13-112.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2875
November 2010
October 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01110460
PRISMA
Yes
Gabriele Nicolini, Chiesi Farmaceutici
Chiesi Farmaceutici S.p.A.
Medidata Solutions
Study Director: Claudio Terzano Policlinico Umberto I Roma
Chiesi Farmaceutici S.p.A.
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP