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CompletedNCT01513837IRIS-ASMAUpdated Sep 10, 2012

Rinitis y Sinusitis según la Gravedad Del Asma

An observational study in Asthma, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Completed at 1 site in Spain. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-09-10.

Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
450
Ages
18 Years to 70 Years
Sex
All
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Study 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.

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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.

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Conditions studied

  • Asthma

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03

In context

Sinusitis

415 studies on the registry are indexed under Sinusitis; 46 are open to participants now.

This study's planned enrollment of 450 is above the median of 110 across 76 observational studies indexed under Sinusitis.

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Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 335 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Hospitals in Spain and Latin America

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

Exclusion Criteria:

  • Illiterate patients;
  • very severe, disabling comorbidity;
  • prior non-inflammatory nasosinusal disease
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
450 participants (estimated)
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Study locations

1 site
  • Sociedad Española de Neumología y Cirugía Torácica (SEPAR)
    Barcelona, Catalonia 08029, Spain
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01513837
Lead sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Sociedad Española de Neumología y Cirugía Torácica
Responsible party
José Antonio Castillo Vizuete (MD, Sociedad Española de Neumología y Cirugía Torácica) — Principal investigator
First posted
Jan 20, 2012
Start date
Mar 2011
Primary completion
Feb 2012
Completion
Sep 2012
Last update
Sep 10, 2012
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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