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

This study has suspended participant recruitment.
(Awaiting results from sub analysis to decide if study continuesé)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00967967
First Posted: August 28, 2009
Last Update Posted: May 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Louis-Philippe Boulet, Laval University
  Purpose
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.

Condition Intervention
Asthma Rhinitis Drug: Medication Mometasone furoate and desloratadine

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Validation of a Rhinitis Control Tool : the Rhinitis Control Scoring System (RCSS)

Resource links provided by NLM:


Further study details as provided by Louis-Philippe Boulet, Laval University:

Primary Outcome Measures:
  • 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 Measures:
  • The relationship between rhinitis control and asthma control. [ Time Frame: March to November 2009 ]

Estimated Enrollment: 50
Study Start Date: March 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Mometasone furoate and desloratadine
Mometasone and desloratadine treatment
Drug: Medication Mometasone furoate and desloratadine
One month treatment with both drugs
Other Names:
  • Nasonex
  • Aerius

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • asthma
  • seasonal allergic rhinitis

Exclusion Criteria:

  • smoking
  • nasal polyposis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00967967


Locations
Canada, Quebec
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Laval University
Investigators
Principal Investigator: Louis-Philippe Boulet, MD Institut universitaire de cardiologie et de pneumologie de Québec
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Louis-Philippe Boulet, Professeur, Laval University
ClinicalTrials.gov Identifier: NCT00967967     History of Changes
Other Study ID Numbers: CER 20389
First Submitted: August 26, 2009
First Posted: August 28, 2009
Last Update Posted: May 27, 2013
Last Verified: May 2013

Keywords provided by Louis-Philippe Boulet, Laval University:
control
symptoms

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Mometasone Furoate
Desloratadine
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents