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Rinitis y Sinusitis según la Gravedad Del Asma (IRIS-ASMA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01513837
First Posted: January 20, 2012
Last Update Posted: September 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sociedad Española de Neumología y Cirugía Torácica
Information provided by (Responsible Party):
José Antonio Castillo Vizuete, Sociedad Española de Neumología y Cirugía Torácica
  Purpose
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.

Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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)

Resource links provided by NLM:


Further study details as provided by José Antonio Castillo Vizuete, Sociedad Española de Neumología y Cirugía Torácica:

Estimated Enrollment: 450
Study Start Date: March 2011
Study Completion Date: September 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Hospitals in Spain and Latin America
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01513837


Locations
Spain
Sociedad Española de Neumología y Cirugía Torácica (SEPAR)
Barcelona, Catalonia, Spain, 08029
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sociedad Española de Neumología y Cirugía Torácica
  More Information

Responsible Party: José Antonio Castillo Vizuete, MD, Sociedad Española de Neumología y Cirugía Torácica
ClinicalTrials.gov Identifier: NCT01513837     History of Changes
Other Study ID Numbers: SEPARALAT-1010-PII
First Submitted: January 17, 2012
First Posted: January 20, 2012
Last Update Posted: September 10, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases