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Prospective Study on Asthma Control (PRISMA)

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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.

Study Description
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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.


Condition or disease
Asthma

Study Design
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Study Type : Observational
Actual Enrollment : 2875 participants
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
Study Start Date : January 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Asthma control test score [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. EuroQoL test score [ Time Frame: 3 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01110460


Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Medidata Solutions
Investigators
Study Director: Claudio Terzano Policlinico Umberto I Roma
More Information
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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
First Posted: April 26, 2010    Key Record Dates
Last Update Posted: February 1, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases