Omnaris Versus Levocetirizine Phase 4 Study

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01430260
• Other study ID #: HANDOK2010.07
• Status: Completed
• Phase: Phase 4
• First received: September 6, 2011
• Last updated: September 5, 2012
• Start date: January 2011
• Est. completion date: July 2012

Study information

• Verified date: September 2012
• Source: Handok Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 349
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 ß-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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis

Intervention

Drug:
• Ciclesonide
200 ? once daily
• Levocetirizine
5mg once daily
• Ciclesonide & Levocetirizine
Omnaris (ciclesonide) 200 ? once daily Levocetirizine 5mg once daily

Locations

Country	Name	City	State
Korea, Republic of	handok pharmaceuticals co. LTD	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Handok Pharmaceuticals Co., Ltd.	Takeda

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rTNSS	change from baseline in the average of AM and PM patient assessed reflective TNSS	2 weeks	No
Secondary	rTOSS	Reflective total ocular symptom sores	2 weeks	No
Secondary	TNSS	Patient assessed individual TNSS	2 weeks	No
Secondary	PANS	Physician-assessed overall nasal signs and symptoms severity (PANS)	2 weeks	No
Secondary	RQLQ	Rhinoconjunctivitis quality of life questionnaire (RQLQ)	2 weeks	No