Rinitis y Sinusitis según la Gravedad Del Asma (IRIS-ASMA)
| Tracking Information | |
|---|---|
| First Received Date ICMJE | January 17, 2012 |
| Last Updated Date | September 7, 2012 |
| Start Date ICMJE | March 2011 |
| Primary Completion Date | February 2012 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE | Not Provided |
| Original Primary Outcome Measures ICMJE | Not Provided |
| Change History | Complete list of historical versions of study NCT01513837 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Rinitis y Sinusitis según la Gravedad Del Asma |
| Official Title ICMJE | PREVALENCIA, GRAVEDAD E IMPACTO DE LA RINITIS Y DE LA SINUSITIS SEGÚN EL NIVEL DE GRAVEDAD Y CONTROL DEL ASMA (PROYECTO IRIS-ASMA) |
| Brief 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. |
| 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. |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Probability Sample |
| Study Population | Hospitals in Spain and Latin America |
| Condition ICMJE | Asthma |
| Intervention ICMJE | Not Provided |
| Study Group/Cohort (s) | Not Provided |
| Publications * | Not Provided |
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|
| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Estimated Enrollment ICMJE | 450 |
| Completion Date | September 2012 |
| Primary Completion Date | February 2012 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
| Gender | Both |
| Ages | 18 Years to 70 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Spain |
| Administrative Information | |
| NCT Number ICMJE | NCT01513837 |
| Other Study ID Numbers ICMJE | SEPARALAT-1010-PII |
| Has Data Monitoring Committee | Not Provided |
| Responsible Party | José Antonio Castillo Vizuete, Sociedad Española de Neumología y Cirugía Torácica |
| Study Sponsor ICMJE | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
| Collaborators ICMJE | Sociedad Española de Neumología y Cirugía Torácica |
| Investigators ICMJE | Not Provided |
| Information Provided By | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
| Verification Date | September 2012 |
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|