ClinicalTrials.Veeva

Menu

Control and Burden of Asthma and Rhinitis (ICAR)

U

Universidade do Porto

Status

Completed

Conditions

Asthma
Rhinitis

Treatments

Other: Diagnostic tests, medical interview and questionnaires

Study type

Observational

Funder types

Other

Identifiers

NCT01771120
PTDC/SAU-SAP/119192/2010

Details and patient eligibility

About

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)

Full 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.

Enrollment

858 patients

Sex

All

Ages

3 to 90 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

858 participants in 4 patient groups

Asthma Group
Description:
Subjects will undergo diagnostic tests, medical interview and questionnaires
Treatment:
Other: Diagnostic tests, medical interview and questionnaires
Rhinitis Group
Description:
Subjects will undergo diagnostic tests, medical interview and questionnaires
Treatment:
Other: Diagnostic tests, medical interview and questionnaires
Asthma and Rhinitis Group
Description:
Subjects will undergo diagnostic tests, medical interview and questionnaires
Treatment:
Other: Diagnostic tests, medical interview and questionnaires
Healthy Group
Description:
Subjects will undergo diagnostic tests, medical interview and questionnaires
Treatment:
Other: Diagnostic tests, medical interview and questionnaires

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems