Control and Burden of Asthma and Rhinitis (ICAR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Universidade do Porto
Sponsor:
Collaborators:
Fundação para a Ciência e a Tecnologia
Fundação Calouste Gulbenkian
Sociedade Portuguesa de Alergologia e Imunologia Clínica
Associação Portuguesa de Asmáticos e Alérgicos
Information provided by (Responsible Party):
Universidade do Porto
ClinicalTrials.gov Identifier:
NCT01771120
First received: January 15, 2013
Last updated: May 27, 2014
Last verified: November 2012
  Purpose

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)


Condition Intervention
Asthma
Rhinitis
Other: Diagnostic tests, medical interview and questionnaires

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Control and Burden of Asthma and Rhinitis

Resource links provided by NLM:


Further study details as provided by Universidade do Porto:

Primary Outcome Measures:
  • To validate the survey instruments used PAPS and PACS, with clinical and objective tests [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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



Biospecimen Retention:   Samples With DNA

Serum will be retained.


Estimated Enrollment: 750
Study Start Date: October 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Asthma Group
Subjects will undergo diagnostic tests, medical interview and questionnaires
Other: Diagnostic tests, medical interview and questionnaires
All patients will perform these interventions.
Rhinitis Group
Subjects will undergo diagnostic tests, medical interview and questionnaires
Other: Diagnostic tests, medical interview and questionnaires
All patients will perform these interventions.
Asthma and Rhinitis Group
Subjects will undergo diagnostic tests, medical interview and questionnaires
Other: Diagnostic tests, medical interview and questionnaires
All patients will perform these interventions.
Healthy Group
Subjects will undergo diagnostic tests, medical interview and questionnaires
Other: Diagnostic tests, medical interview and questionnaires
All patients will perform these interventions.

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

Ages Eligible for Study:   3 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Community sample.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01771120

Contacts
Contact: João A Fonseca, MD, PhD 00351914767661 jfonseca@med.up.pt
Contact: Luis Araujo, MD 00351965416733 luisaraujo78@gmail.com

Locations
Portugal
Instituto CUF Porto Recruiting
Porto, Portugal, 4460-188
Contact: João A Fonseca, PhD    00351914767661    jfonseca@med.up.pt   
Contact: Luís Araujo, MD    00351965416733    luisaraujo78@gmail.com   
Sub-Investigator: Luis Araujo, MD         
Sponsors and Collaborators
Universidade do Porto
Fundação para a Ciência e a Tecnologia
Fundação Calouste Gulbenkian
Sociedade Portuguesa de Alergologia e Imunologia Clínica
Associação Portuguesa de Asmáticos e Alérgicos
Investigators
Principal Investigator: João A Fonseca, PhD Faculdade de Medicina da Universidade do Porto
  More Information

Publications:
Bousquet J, Khaltaev N, Cruz AA, Denburg J, Fokkens WJ, Togias A, Zuberbier T, Baena-Cagnani CE, Canonica GW, van Weel C, Agache I, Aït-Khaled N, Bachert C, Blaiss MS, Bonini S, Boulet LP, Bousquet PJ, Camargos P, Carlsen KH, Chen Y, Custovic A, Dahl R, Demoly P, Douagui H, Durham SR, van Wijk RG, Kalayci O, Kaliner MA, Kim YY, Kowalski ML, Kuna P, Le LT, Lemiere C, Li J, Lockey RF, Mavale-Manuel S, Meltzer EO, Mohammad Y, Mullol J, Naclerio R, O'Hehir RE, Ohta K, Ouedraogo S, Palkonen S, Papadopoulos N, Passalacqua G, Pawankar R, Popov TA, Rabe KF, Rosado-Pinto J, Scadding GK, Simons FE, Toskala E, Valovirta E, van Cauwenberge P, Wang DY, Wickman M, Yawn BP, Yorgancioglu A, Yusuf OM, Zar H, Annesi-Maesano I, Bateman ED, Ben Kheder A, Boakye DA, Bouchard J, Burney P, Busse WW, Chan-Yeung M, Chavannes NH, Chuchalin A, Dolen WK, Emuzyte R, Grouse L, Humbert M, Jackson C, Johnston SL, Keith PK, Kemp JP, Klossek JM, Larenas-Linnemann D, Lipworth B, Malo JL, Marshall GD, Naspitz C, Nekam K, Niggemann B, Nizankowska-Mogilnicka E, Okamoto Y, Orru MP, Potter P, Price D, Stoloff SW, Vandenplas O, Viegi G, Williams D; World Health Organization; GA(2)LEN; AllerGen. Allergic Rhinitis and its Impact on Asthma (ARIA) 2008 update (in collaboration with the World Health Organization, GA(2)LEN and AllerGen). Allergy. 2008 Apr;63 Suppl 86:8-160. Review. No abstract available.

Responsible Party: Universidade do Porto
ClinicalTrials.gov Identifier: NCT01771120     History of Changes
Other Study ID Numbers: PTDC/SAU-SAP/119192/2010
Study First Received: January 15, 2013
Last Updated: May 27, 2014
Health Authority: Portugal: Health Ethic Committee

Keywords provided by Universidade do Porto:
Asthma
Rhinitis
Control
Burden

Additional relevant MeSH terms:
Asthma
Rhinitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on August 21, 2014