NCT01430260CompletedPhase 4
A Multi-center, Open, Randomized, Three-arm, Parallel-group, Phase IV Study to Compare the Efficacy of Ciclesonide Nasal Spray and Levocetirizine, Alone and in Combination for the Patient With Allergic Rhinitis
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Handok Inc.
- Enrollment
- 349
- Locations
- 1
- Primary Endpoint
- rTNSS
Study Overview
Brief Summary
This i a comparison of the efficacy ciclesonide nasal spray and levocetirizine, alone and in combination.
Detailed Description
randomized, open-label, three arm, parallel group, multi-center study
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Allergic rhinitis patients aged ≥ 18 years (with a history of AR of 1 years or longer)
- •Moderate to severe patient according to ARIA guideline
- •To have a demonstrated positive skin prick test or other serologic tests to at least 1 allergen.
- •Subjects who complete the subject diary(S) at least 70%.
Exclusion Criteria
- •Nasal pathology, including nasal polyps, clinically relevant respiratory tract malformations, recent nasal biopsy (within 60 days), nasal trauma, nasal surgery, atrophic rhinitis, rhinitis medicamentosa (within 60 days), asthma requiring corticosteroid treatment
- •Hypersensitivity to corticosteroid and/or hydroxyzine
- •Hypersensitivity to galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption
- •A history of respiratory tract infection or disorder within 2 weeks of the screening visit or had a respiratory tract infection during baseline
- •Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of β-agonists
- •Treated with systemic corticosteroids (within 8 weeks of study initiation) or topical corticosteroids (> 1% hydrocortisone, within 4 weeks of study initiation) or antibiotics (within 2 weeks of first visit)
Arms & Interventions
ciclesonide nasal spray
Experimental
ciclesonide nasal spray, alone
Intervention: Ciclesonide (Drug)
Levocetirizine
Active Comparator
Levocetirizine, alone
Intervention: Levocetirizine (Drug)
Ciclesonide nasal spray & Levocetirizine
Active Comparator
Ciclesonide nasal spray & Levocetirizine in combination
Intervention: Ciclesonide & Levocetirizine (Drug)
Outcomes
Primary Outcomes
rTNSS
Time Frame: 2 weeks
change from baseline in the average of AM and PM patient assessed reflective TNSS
Secondary Outcomes
- rTOSS(2 weeks)
- TNSS(2 weeks)
- PANS(2 weeks)
- RQLQ(2 weeks)
Investigators
Study Sites (1)
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