Validation of the Rhinitis Control Scoring System (RCSS)

This study has suspended participant recruitment.
(Awaiting results from sub analysis to decide if study continuesé)
Sponsor:
Information provided by (Responsible Party):
Louis-Philippe Boulet, Laval University
ClinicalTrials.gov Identifier:
NCT00967967
First received: August 26, 2009
Last updated: May 24, 2013
Last verified: May 2013
  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: 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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The relationship between rhinitis control and asthma control. [ Time Frame: March to November 2009 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • asthma
  • seasonal allergic rhinitis

Exclusion Criteria:

  • smoking
  • nasal polyposis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Louis-Philippe Boulet, Professeur, Laval University
ClinicalTrials.gov Identifier: NCT00967967     History of Changes
Other Study ID Numbers: CER 20389
Study First Received: August 26, 2009
Last Updated: May 24, 2013
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Laval University:
control
symptoms

Additional relevant MeSH terms:
Asthma
Rhinitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Mometasone furoate
Desloratadine
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on August 18, 2014