Validation of the Rhinitis Control Scoring System (RCSS) | NCT00967967

Studies
Validation of the Rhinitis Control Scoring System (RCSS)

NCT00967967

Sponsor

Laval University

Status

Suspended

Last Update Posted

May 27, 2013Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Asthma
Rhinitis

Interventions

Medication Mometasone furoate and desloratadine

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Awaiting results from sub analysis to decide if study continuesé

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Jun 2014Estimated

Completion Date

Sep 2014Estimated

First Submitted Date

Aug 26, 2009

First Submission Date that Met QC Criteria

Aug 27, 2009

First Posted Date

Aug 28, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2013

Last Update Posted Date

May 27, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mometasone furoate and desloratadine	Other	Mometasone and desloratadine treatment	Drug: Medication Mometasone furoate and desloratadine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Medication Mometasone furoate and desloratadine	Drug	One month treatment with both drugs	Mometasone furoate and desloratadine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
The relationship between rhinitis control and asthma control.		March to November 2009

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

asthma
seasonal allergic rhinitis

Exclusion Criteria:

smoking
nasal polyposis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Louis-Philippe Boulet, MD	Institut universitaire de cardiologie et de pneumologie de Québec, University Laval	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut universitaire de cardiologie et de pneumologie de Québec		Québec	Quebec	G1V 4G5	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26867531	Derived	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.

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

ID	Term
C121345	desloratadine
D000068656	Mometasone Furoate

ID	Term
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473

ID	Term
D001249	Asthma
D012220	Rhinitis