Control and Burden of Asthma and Rhinitis (ICAR)

October 30, 2014 updated by: Universidade do Porto
An observational cross-sectional study will include 750 individuals of all ages, divided in 4 groups: 1) Patients with a self-reported diagnosis of asthma alone (n=150), 2) Patients with a self-reported diagnosis of rhinitis alone (n=150), 3) Patients with a self-reported diagnosis of asthma and rhinitis (n=150) and 4) Patients with no history of respiratory symptoms or diseases (n=300)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

During 2010, we've conducted two cross-sectional, telephonic national surveys that assessed the prevalence (Portuguese Asthma Prevalence Survey - PAPS) and the control (Portuguese Asthma Control Survey - PACS) of asthma and rhinitis. Before these surveys there was no country-wide data on prevalence or about the control of asthma in Portugal.We propose an additional study that will apply a comprehensive set of diagnostic tests and clinical assessment to a sub-sample of participants in the PACS study. The effect of asthma, rhinitis and their control on personal and social burden will be studied comparing patients with current asthma and/or rhinitis and individuals with no respiratory symptoms.Sample size calculations were based on the comparison of quality of life measured by WHOQOL-BREF in patients with different diagnosis. Data collection includes anthropometric measurements, lung function & inflammation tests, allergy tests, a structured clinical interview and standardized questionnaires. Research assistants performing the evaluations will be blinded to the subject classification in PAPS and PACS and to the results of the questionnaires administered, namely the GA2LEN survey instrument and CARAT. The data collection will be organized with the local Public Health delegate and will take place as close as possible to the participants' communities at a local health unit or in the surrounding area, in order to minimize dropouts.

Study Type

Observational

Enrollment (Actual)

858

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Porto, Portugal, 4460-188
        • Instituto CUF Porto

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

3 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community sample.

Description

Inclusion Criteria:

All subjects that were included in PACS and that have expressed their willingness to participate in a clinical assessment of asthma.

New participants that have medical diagnosis of asthma, rhinitis, or are healthy.

Exclusion Criteria:

Persons who don't understand spoken portuguese. Persons who have cognitive or physical conditions thta could hamper their participation in the study.

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

  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Asthma Group
Subjects will undergo diagnostic tests, medical interview and questionnaires
Other: Diagnostic tests, medical interview and questionnaires
All patients will perform these interventions.
Rhinitis Group
Subjects will undergo diagnostic tests, medical interview and questionnaires
Other: Diagnostic tests, medical interview and questionnaires
All patients will perform these interventions.
Asthma and Rhinitis Group
Subjects will undergo diagnostic tests, medical interview and questionnaires
Other: Diagnostic tests, medical interview and questionnaires
All patients will perform these interventions.
Healthy Group
Subjects will undergo diagnostic tests, medical interview and questionnaires
Other: Diagnostic tests, medical interview and questionnaires
All patients will perform these interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To validate the survey instruments used PAPS and PACS, with clinical and objective tests
Time Frame: 15 months
To compare the classifications of: a) asthma and/or rhinitis and b) controlled diseases obtained by the survey instruments of PAPS and PACS with the classifications obtained using clinical evaluation and diagnostic tests;
15 months
To compare the disease burden of the different groups of participants
Time Frame: 15 months

To assess the effect of diagnosis and of its control on the disease burden (quality of life, use of healthcare resources and work/school absenteeism) in the following groups:

a. Diagnosis i.patients with asthma alone ii.patients with rhinitis alone iii.patients with asthma plus rhinitis iv.Individuals without respiratory symptoms b.Control i.Controlled ii.Not controlled
15 months

Collaborators and Investigators

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

Sponsor

Universidade do Porto

Collaborators

Fundação para a Ciência e a Tecnologia
FUNDAÇAO CALOUSTE GULBENKIAN
Sociedade Portuguesa de Alergologia e Imunologia Clinica
Associação Portuguesa de Asmáticos e Alérgicos

Investigators

  • Principal Investigator: João A Fonseca, PhD, Universidade do Porto

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

October 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

January 15, 2013

First Submitted That Met QC Criteria

January 15, 2013

First Posted (Estimate)

January 18, 2013

Study Record Updates

Last Update Posted (Estimate)

October 31, 2014

Last Update Submitted That Met QC Criteria

October 30, 2014

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTDC/SAU-SAP/119192/2010

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.

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