NCT01430260

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
349

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

September 6, 2012

Status Verified

September 1, 2012

Enrollment Period

1.5 years

First QC Date

September 6, 2011

Last Update Submit

September 5, 2012

Conditions

Allergic Rhinitis

Keywords

efficacyciclesonidelevocetirizineallergic rhinitis

Outcome Measures

Primary Outcomes (1)

  • rTNSS

    change from baseline in the average of AM and PM patient assessed reflective TNSS

    2 weeks

Secondary Outcomes (4)

  • rTOSS

    2 weeks

  • TNSS

    2 weeks

  • PANS

    2 weeks

  • RQLQ

    2 weeks

Study Arms (3)

ciclesonide nasal spray

EXPERIMENTAL

ciclesonide nasal spray, alone

Drug: Ciclesonide

Levocetirizine

ACTIVE COMPARATOR

Levocetirizine, alone

Drug: Levocetirizine

Ciclesonide nasal spray & Levocetirizine

ACTIVE COMPARATOR

Ciclesonide nasal spray \& Levocetirizine in combination

Drug: Ciclesonide & Levocetirizine

Interventions

CiclesonideDRUG

200 ㎍ once daily

Also known as: Omnaris
ciclesonide nasal spray
LevocetirizineDRUG

5mg once daily

Also known as: XYZAL
Levocetirizine
Ciclesonide & LevocetirizineDRUG

* Omnaris (ciclesonide) 200 ㎍ once daily * Levocetirizine 5mg once daily

Also known as: Omnaris nasal spray, XYZAL
Ciclesonide nasal spray & Levocetirizine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

handok pharmaceuticals co. LTD

Seoul, Seoul, 135-755, South Korea

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

ciclesonidelevocetirizine

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Moonhwa Park, Doctor

    Handok Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2011

First Posted

September 8, 2011

Study Start

January 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

September 6, 2012

Record last verified: 2012-09

Locations

KR(1)