NCT00967967

Brief Summary

Many patients suffering from allergic rhinitis do not recognize or perceive their symptoms. Instruments have been developed to assess quality of life in rhinitis, asthma or both, but there is a need to develop validated tools or methods to assess rhinitis control among rhinitis and/or asthmatic patients. The aim of this study is to assess the discriminative and evaluative properties of the RCSS in asthmatic patients with allergic rhinitis.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Mar 2009

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
suspended

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, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2009

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

May 27, 2013

Status Verified

May 1, 2013

Enrollment Period

5.3 years

First QC Date

August 26, 2009

Last Update Submit

May 24, 2013

Conditions

Keywords

controlsymptoms

Outcome Measures

Primary Outcomes (1)

  • Discriminative (internal consistency, cross sectional construct validity and reliability) and evaluative (responsiveness and longitudinal construct validity) properties of the RCSS.

    March to November 2009

Secondary Outcomes (1)

  • The relationship between rhinitis control and asthma control.

    March to November 2009

Study Arms (1)

Mometasone furoate and desloratadine

OTHER

Mometasone and desloratadine treatment

Drug: Medication Mometasone furoate and desloratadine

Interventions

One month treatment with both drugs

Also known as: Nasonex, Aerius
Mometasone furoate and desloratadine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • asthma
  • seasonal allergic rhinitis

You may not qualify if:

  • smoking
  • nasal polyposis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (1)

  • Boulay ME, Boulet LP. The Rhinitis Control Scoring System: Development and validation. Am J Rhinol Allergy. 2016 Jan-Feb;30(1):54-9. doi: 10.2500/ajra.2016.30.4260.

MeSH Terms

Conditions

AsthmaRhinitis

Interventions

desloratadineMometasone Furoate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Louis-Philippe Boulet, MD

    Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professeur

Study Record Dates

First Submitted

August 26, 2009

First Posted

August 28, 2009

Study Start

March 1, 2009

Primary Completion

June 1, 2014

Study Completion

September 1, 2014

Last Updated

May 27, 2013

Record last verified: 2013-05

Locations