Control and Burden of Asthma and Rhinitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universidade do Porto
- Enrollment
- 858
- Locations
- 1
- Primary Endpoint
- To validate the survey instruments used PAPS and PACS, with clinical and objective tests
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 3 Years to 90 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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;
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
Secondary Outcomes
No secondary outcomes reported