Back to resultsValidation of the Rhinitis Control Scoring System (RCSS) (RCSS)
Primary Purpose
Asthma, Rhinitis
Status
Suspended
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Medication Mometasone furoate and desloratadine
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring control, symptoms
Eligibility Criteria
Inclusion Criteria:
- asthma
- seasonal allergic rhinitis
Exclusion Criteria:
- smoking
- nasal polyposis
Sites / Locations
- Institut universitaire de cardiologie et de pneumologie de Québec
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Mometasone furoate and desloratadine
Arm Description
Mometasone and desloratadine treatment
Outcomes
Primary Outcome Measures
Discriminative (internal consistency, cross sectional construct validity and reliability) and evaluative (responsiveness and longitudinal construct validity) properties of the RCSS.
Secondary Outcome Measures
The relationship between rhinitis control and asthma control.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00967967
Brief Title
Validation of the Rhinitis Control Scoring System (RCSS)
Acronym
RCSS
Official Title
Validation of a Rhinitis Control Tool : the Rhinitis Control Scoring System (RCSS)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Suspended
Why Stopped
Awaiting results from sub analysis to decide if study continuesé
Study Start Date
March 2009 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
September 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Allergic asthmatic subjects showing seasonal rhinitis symptoms will be recruited. The discriminative (internal consistency, cross sectional construct validity and reliability) and evaluative (responsiveness and longitudinal construct validity) properties of the RCSS will be evaluated as well as the relationship between rhinitis control and asthma control. RCSS will be completed at various time points during the seasonal allergic period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Rhinitis
Keywords
control, symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mometasone furoate and desloratadine
Arm Type
Other
Arm Description
Mometasone and desloratadine treatment
Intervention Type
Drug
Intervention Name(s)
Medication Mometasone furoate and desloratadine
Other Intervention Name(s)
Nasonex, Aerius
Intervention Description
One month treatment with both drugs
Primary Outcome Measure Information:
Title
Discriminative (internal consistency, cross sectional construct validity and reliability) and evaluative (responsiveness and longitudinal construct validity) properties of the RCSS.
Time Frame
March to November 2009
Secondary Outcome Measure Information:
Title
The relationship between rhinitis control and asthma control.
Time Frame
March to November 2009
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
asthma
seasonal allergic rhinitis
Exclusion Criteria:
smoking
nasal polyposis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis-Philippe Boulet, MD
Organizational Affiliation
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut universitaire de cardiologie et de pneumologie de Québec
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
26867531
Citation
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.
Results Reference
derived
Learn more about this trial
Validation of the Rhinitis Control Scoring System (RCSS)
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