Control and Burden of Asthma and Rhinitis

NCT ID: NCT01771120

Last Updated: 2014-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

858 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-09-30

Brief Summary

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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

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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

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Asthma Rhinitis

Keywords

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Asthma Rhinitis Control Burden

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Asthma Group

Subjects will undergo diagnostic tests, medical interview and questionnaires

Diagnostic tests, medical interview and questionnaires

Intervention Type OTHER

All patients will perform these interventions.

Rhinitis Group

Subjects will undergo diagnostic tests, medical interview and questionnaires

Diagnostic tests, medical interview and questionnaires

Intervention Type OTHER

All patients will perform these interventions.

Asthma and Rhinitis Group

Subjects will undergo diagnostic tests, medical interview and questionnaires

Diagnostic tests, medical interview and questionnaires

Intervention Type OTHER

All patients will perform these interventions.

Healthy Group

Subjects will undergo diagnostic tests, medical interview and questionnaires

Diagnostic tests, medical interview and questionnaires

Intervention Type OTHER

All patients will perform these interventions.

Interventions

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Diagnostic tests, medical interview and questionnaires

All patients will perform these interventions.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundação para a Ciência e a Tecnologia

OTHER

Sponsor Role collaborator

Fundação Calouste Gulbenkian

UNKNOWN

Sponsor Role collaborator

Sociedade Portuguesa de Alergologia e Imunologia Clínica

UNKNOWN

Sponsor Role collaborator

Associação Portuguesa de Asmáticos e Alérgicos

UNKNOWN

Sponsor Role collaborator

Universidade do Porto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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João A Fonseca, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade do Porto

Locations

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Instituto CUF Porto

Porto, Porto District, Portugal

Site Status

Countries

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Portugal

References

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Gibson PG, Simpson JL. The overlap syndrome of asthma and COPD: what are its features and how important is it? Thorax. 2009 Aug;64(8):728-35. doi: 10.1136/thx.2008.108027.

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Reference Type BACKGROUND
PMID: 18331513 (View on PubMed)

National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043.

Reference Type BACKGROUND
PMID: 17983880 (View on PubMed)

Bateman ED, Hurd SS, Barnes PJ, Bousquet J, Drazen JM, FitzGerald JM, Gibson P, Ohta K, O'Byrne P, Pedersen SE, Pizzichini E, Sullivan SD, Wenzel SE, Zar HJ. Global strategy for asthma management and prevention: GINA executive summary. Eur Respir J. 2008 Jan;31(1):143-78. doi: 10.1183/09031936.00138707.

Reference Type BACKGROUND
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Chapman KR, Boulet LP, Rea RM, Franssen E. Suboptimal asthma control: prevalence, detection and consequences in general practice. Eur Respir J. 2008 Feb;31(2):320-5. doi: 10.1183/09031936.00039707. Epub 2007 Oct 24.

Reference Type BACKGROUND
PMID: 17959642 (View on PubMed)

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Reference Type BACKGROUND
PMID: 12522488 (View on PubMed)

Juniper EF, Chauhan A, Neville E, Chatterjee A, Svensson K, Mork AC, Stahl E. Clinicians tend to overestimate improvements in asthma control: an unexpected observation. Prim Care Respir J. 2004 Dec;13(4):181-4. doi: 10.1016/j.pcrj.2004.04.003.

Reference Type BACKGROUND
PMID: 16701667 (View on PubMed)

Lopes C, Fonseca J, Delgado L, Moreira A, Barros R, Moreira P, Castelo-Branco Mda G. Assessing asthma control: questionnaires and exhaled nitric oxide provide complementary information. Eur Respir J. 2008 Nov;32(5):1419-20. doi: 10.1183/09031936.00093008. No abstract available.

Reference Type BACKGROUND
PMID: 18978149 (View on PubMed)

Clatworthy J, Price D, Ryan D, Haughney J, Horne R. The value of self-report assessment of adherence, rhinitis and smoking in relation to asthma control. Prim Care Respir J. 2009 Dec;18(4):300-5. doi: 10.4104/pcrj.2009.00037.

Reference Type BACKGROUND
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Brozek JL, Bousquet J, Baena-Cagnani CE, Bonini S, Canonica GW, Casale TB, van Wijk RG, Ohta K, Zuberbier T, Schunemann HJ; Global Allergy and Asthma European Network; Grading of Recommendations Assessment, Development and Evaluation Working Group. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines: 2010 revision. J Allergy Clin Immunol. 2010 Sep;126(3):466-76. doi: 10.1016/j.jaci.2010.06.047.

Reference Type BACKGROUND
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Nogueira-Silva L, Martins SV, Cruz-Correia R, Azevedo LF, Morais-Almeida M, Bugalho-Almeida A, Vaz M, Costa-Pereira A, Fonseca JA. Control of allergic rhinitis and asthma test--a formal approach to the development of a measuring tool. Respir Res. 2009 Jun 17;10(1):52. doi: 10.1186/1465-9921-10-52.

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Fonseca JA, Nogueira-Silva L, Morais-Almeida M, Azevedo L, Sa-Sousa A, Branco-Ferreira M, Fernandes L, Bousquet J. Validation of a questionnaire (CARAT10) to assess rhinitis and asthma in patients with asthma. Allergy. 2010 Aug;65(8):1042-8. doi: 10.1111/j.1398-9995.2009.02310.x. Epub 2010 Feb 1.

Reference Type BACKGROUND
PMID: 20121755 (View on PubMed)

Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.

Reference Type BACKGROUND
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O'Carroll RE, Smith K, Couston M, Cossar JA, Hayes PC. A comparison of the WHOQOL-100 and the WHOQOL-BREF in detecting change in quality of life following liver transplantation. Qual Life Res. 2000 Feb;9(1):121-4. doi: 10.1023/a:1008901320492.

Reference Type BACKGROUND
PMID: 10981212 (View on PubMed)

Other Identifiers

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PTDC/SAU-SAP/119192/2010

Identifier Type: -

Identifier Source: org_study_id