Rinitis y Sinusitis según la Gravedad Del Asma

Asthma Clinical Trial

— IRIS-ASMA  

Official title:

PREVALENCIA, GRAVEDAD E IMPACTO DE LA RINITIS Y DE LA SINUSITIS SEGÚN EL NIVEL DE GRAVEDAD Y CONTROL DEL ASMA (PROYECTO IRIS-ASMA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01513837
• Other study ID #: SEPARALAT-1010-PII
• Status: Completed
• Phase: N/A
• First received: January 17, 2012
• Last updated: September 7, 2012
• Start date: March 2011
• Est. completion date: September 2012

Study information

• Verified date: September 2012
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health and Consumption
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: September 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
Spain	Sociedad Española de Neumología y Cirugía Torácica (SEPAR)	Barcelona	Catalonia

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Sociedad Española de Neumología y Cirugía Torácica

Country where clinical trial is conducted

Spain,