Omnaris Versus Levocetirizine Phase 4 Study

Handok

Status and phase: Completed; Phase 4

Conditions: Allergic Rhinitis

Treatments: Drug: Ciclesonide & Levocetirizine; Drug: Ciclesonide; Drug: Levocetirizine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01430260

HANDOK2010.07

Details and patient eligibility

About

This i a comparison of the efficacy ciclesonide nasal spray and levocetirizine, alone and in combination.

Full description

randomized, open-label, three arm, parallel group, multi-center study

Enrollment: 349 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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349 participants in 3 patient groups

ciclesonide nasal spray

Experimental group

Description:

ciclesonide nasal spray, alone

Treatment:

Drug: Ciclesonide

Levocetirizine

Active Comparator group

Description:

Levocetirizine, alone

Treatment:

Drug: Levocetirizine

Ciclesonide nasal spray & Levocetirizine

Active Comparator group

Description:

Ciclesonide nasal spray \& Levocetirizine in combination

Treatment:

Drug: Ciclesonide & Levocetirizine