NCT01771120

Control and Burden of Asthma and Rhinitis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 858 (actual)
• Sponsor: Universidade do Porto · Academic / Other
• Sex: All
• Age: 3 Years – 90 Years
• Healthy volunteers: Accepted

Summary

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)

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.

Conditions

• Asthma
• Rhinitis

Interventions

Type	Name	Description
OTHER	Diagnostic tests, medical interview and questionnaires	All patients will perform these interventions.

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-07-01
• Completion: 2014-09-01
• First posted: 2013-01-18
• Last updated: 2014-10-31

Locations

1 site across 1 country: Portugal