Rinitis y Sinusitis según la Gravedad Del Asma

NCT ID: NCT01513837

Last Updated: 2012-09-10

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

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-09-30

Brief Summary

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Based on the evidence for the "common pathway" in asthma presentation, our working hypothesis is that asthma severity and lack of control are related to the prevalence and severity of nasal and sinusal inflammatory pathology, and especially to chronic rhinosinusitis with nasal polyps.

Detailed Description

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Primary objective: To assess the prevalence and severity of rhinitis and rhinosinusitis, with or without nasal polyposis, in asthmatic patients depending on severity of their disease.

Secondary objectives:

To assess the impact of nasal and sinusal pathology on asthma control.

To correlate asthma severity to rhinitis and rhinosinusitis.

To compare the potential association between chronic rhinosinusitis, with and without nasal polyposis, and asthma severity, and to detect radiographic differences, markers of atopy, and pulmonary function.

Conditions

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Asthma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients of both sexes aged 18-70 years attending outpatient clinics diagnosed with asthma at least one year before. GINA/GEMA criteria will be used to diagnose asthma and to rate its severity.

Exclusion Criteria

* Illiterate patients;
* very severe, disabling comorbidity;
* prior non-inflammatory nasosinusal disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sociedad Española de Neumología y Cirugía Torácica

OTHER

Sponsor Role collaborator

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role lead

Responsible Party

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José Antonio Castillo Vizuete

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sociedad Española de Neumología y Cirugía Torácica (SEPAR)

Barcelona, Catalonia, Spain

Site Status

Countries

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Spain

Other Identifiers

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SEPARALAT-1010-PII

Identifier Type: -

Identifier Source: org_study_id