NCT02879929

Brief Summary

Nasal symptoms are the main elements that lead to a therapeutic decision and allow for evaluating treatment effects or natural evolution. Despite availability of several questionnaires with good measurement qualities, no systematic assessment takes into account the specific physical and psychosocial consequences of each of the six main nasal symptoms, independently of the disease. The study proposed to measure these symptoms with the use of a selfreport questionnaire and to test the validity of the questionnaire in a large representative sample of patients attending outpatient rhinologic clinics.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
759

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2005

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

October 1, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
9.7 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 26, 2016

Completed
Last Updated

August 16, 2017

Status Verified

August 1, 2017

Enrollment Period

1.2 years

First QC Date

August 19, 2016

Last Update Submit

August 13, 2017

Conditions

RhinitisNasal Polyps

Keywords

chronic nasal dysfunctionQuality of lifemeasurementself-reporting questionnairedevelopmentvalidation

Outcome Measures

Primary Outcomes (1)

  • Development of the DyNaChron questionnaire for chronic nasal dysfunction

    to develop a self-report questionnaire to assess nose and sinus functional symptoms together with their consequences for physical and psychosocial areas

    6 months

Secondary Outcomes (1)

  • Validation of the DyNaChron questionnaire for chronic nasal dysfunction

    10 months

Eligibility Criteria

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

Patients were consecutively recruited in 16 centers in rhinology outpatient clinics all over France.

You may qualify if:

  • be older than 18 years
  • have nasal or sinus dysfunction for more than 3 months
  • be able to understand and read theFrench language.

You may not qualify if:

  • nasal or sinus tumor or Rendu-Osler disease,
  • patients were under immediate post-operative care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Kacha S, Guillemin F, Jankowski R. Development and validity of the DyNaChron questionnaire for chronic nasal dysfunction. Eur Arch Otorhinolaryngol. 2012 Jan;269(1):143-53. doi: 10.1007/s00405-011-1690-z. Epub 2011 Jul 8.

    PMID: 21739093RESULT

MeSH Terms

Conditions

RhinitisNasal Polyps

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PU-PH

Study Record Dates

First Submitted

August 19, 2016

First Posted

August 26, 2016

Study Start

October 1, 2005

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

August 16, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share