Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prospective Study on Asthma Control (PRISMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01110460
Recruitment Status : Completed
First Posted : April 26, 2010
Last Update Posted : February 1, 2011
Sponsor:
Collaborator:
Medidata Solutions
Information provided by:
Chiesi Farmaceutici S.p.A.

Tracking Information
First Submitted Date April 23, 2010
First Posted Date April 26, 2010
Last Update Posted Date February 1, 2011
Study Start Date January 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 23, 2010)
Asthma control test score [ Time Frame: 3 months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01110460 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 23, 2010)
EuroQoL test score [ Time Frame: 3 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Study on Asthma Control
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
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Asthmatic patients
Condition Asthma
Intervention Not Provided
Study Groups/Cohorts Not Provided
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;13:112. 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.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 23, 2010)
2875
Original Actual Enrollment Same as current
Actual Study Completion Date November 2010
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01110460
Other Study ID Numbers PRISMA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Gabriele Nicolini, Chiesi Farmaceutici
Study Sponsor Chiesi Farmaceutici S.p.A.
Collaborators Medidata Solutions
Investigators
Study Director: Claudio Terzano Policlinico Umberto I Roma
PRS Account Chiesi Farmaceutici S.p.A.
Verification Date January 2011