Clinical trial NCT01771120: Control and Burden of Asthma and Rhinitis
Official title: Control and Burden of Asthma and Rhinitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Rhinitis
Keywords: Asthma
Rhinitis
Control
Burden
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Fundação para a Ciência e a Tecnologia
name: Fundação Calouste Gulbenkian
name: Sociedade Portuguesa de Alergologia e Imunologia Clínica
name: Associação Portuguesa de Asmáticos e Alérgicos
First posted: 2013-01-18
Enrollment: 858
Sex: ALL
Minimum age (years): 3
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To validate the survey instruments used PAPS and PACS, with clinical and objective tests
timeFrame: 15 months
measure: To compare the disease burden of the different groups of participants
timeFrame: 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Instituto CUF Porto
Study officials:
affiliation: Universidade do Porto
name: João A Fonseca, PhD
role: PRINCIPAL_INVESTIGATOR
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