NCT01513837

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 20, 2012

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

September 10, 2012

Status Verified

September 1, 2012

Enrollment Period

11 months

First QC Date

January 17, 2012

Last Update Submit

September 7, 2012

Conditions

Asthma

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hospitals in Spain and Latin America

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sociedad Española de Neumología y Cirugía Torácica (SEPAR)

Barcelona, Catalonia, 08029, Spain

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 17, 2012

First Posted

January 20, 2012

Study Start

March 1, 2011

Primary Completion

February 1, 2012

Study Completion

September 1, 2012

Last Updated

September 10, 2012

Record last verified: 2012-09

Locations

ES(1)