A Study in Subjects With Perennial Allergic Rhinitis
Phase 2
Completed
- Conditions
- Perennial Allergic Rhinitis
- Registration Number
- NCT00210015
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study was to determine the efficacy and safety of the study drug compared to placebo for the treatment of subjects with perennial allergic rhinitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Not specified
- Target Recruitment
- 630
Inclusion Criteria
- Have a documented history of allergy to perennial allergens and demonstrated sensitivity by the results of prick or intradermal skin testing.
- Have a self-reported history of at least mild, intermittent rhinorrhea and nasal blockage/stuffiness due to allergies.
- Have not started or had a change in immunotherapy regimen.
Exclusion Criteria
- Have a physical obstruction in the nose.
- Will likely have an acute increase in severity of allergic rhinitis due to seasonal aeroallergens during the trial.
- Have acute or chronic sinusitis or had previous sinus surgery resulting in a significant change in the sinus or nasal anatomy.
- Have rhinitis medicamentosa or any other acute or chronic condition that could confound evaluations of nasal symptoms.
- Have asthma of sufficient severity to require use of excluded medications.
- Have taken any medications excluded as listed in the protocol.
- Have a clinically significant acute or chronic disease or clinically significant laboratory abnormality.
- Are a current smoker, recent smoker or past smoker as defined in the protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method total nasal symptom score
- Secondary Outcome Measures
Name Time Method global assessment of perennial allergic rhinitis symptoms laboratory tests physical and anterior nasal exams vital signs adverse events change from baseline in quality of life assessments ECG average total nasal symptom scores over various timepoints average individual symptom scores instantaneous assessment of symptoms