Prospective Study on Asthma Control (PRISMA)

January 31, 2011 updated by: Chiesi Farmaceutici S.p.A.

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2875

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Asthmatic patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Asthma control test score
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
EuroQoL test score
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiesi Farmaceutici S.p.A.

Collaborators

Medidata Solutions

Investigators

  • Study Director: Claudio Terzano, Policlinico Umberto I Roma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

April 23, 2010

First Submitted That Met QC Criteria

April 23, 2010

First Posted (Estimate)

April 26, 2010

Study Record Updates

Last Update Posted (Estimate)

February 1, 2011

Last Update Submitted That Met QC Criteria

January 31, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRISMA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asthma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe