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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
History of Changes
  Purpose

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.


Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:
  • Asthma control test score [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • EuroQoL test score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Enrollment: 2875
Study Start Date: January 2009
Study Completion Date: November 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Asthmatic patients

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01110460

Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Medidata Solutions
Investigators
Study Director: Claudio Terzano Policlinico Umberto I Roma
  More Information

No publications provided by Chiesi Farmaceutici S.p.A.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gabriele Nicolini, Chiesi Farmaceutici
ClinicalTrials.gov Identifier: NCT01110460     History of Changes
Other Study ID Numbers: PRISMA
Study First Received: April 23, 2010
Last Updated: January 31, 2011
Health Authority: Italy: Ethics Committee

ClinicalTrials.gov processed this record on March 03, 2015