NCT01470053

Brief Summary

The purpose of this study is to evaluate of efficacy and safety of mometasone furoate plus azelastine HCl in patients with perennial allergic rhinitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
347

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 11, 2011

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

August 27, 2013

Status Verified

November 1, 2011

Enrollment Period

9 months

First QC Date

November 8, 2011

Last Update Submit

August 26, 2013

Conditions

Perennial Allergic Rhinitis

Keywords

mometasone furoateazelastine HClperennial allergic rhinitis

Outcome Measures

Primary Outcomes (1)

  • change from baseline in rTNSS(reflective Total Nasal Symptom Score)

    4 weeks

Secondary Outcomes (5)

  • change from baseline in AM rTNSS(AM reflective Total Nasal Symptom Score)

    4 weeks

  • change from baseline in PM rTNSS(PM reflective Total Nasal Symptom Score)

    4 weeks

  • change from baseline in iTNSS(instantaneous Total Nasal Symptom Score)

    4 weeks

  • change from baseline in AM iTNSS(AM instantaneous Total Nasal Symptom Score)

    4 weeks

  • change from baseline in PM iTNSS(PM instantaneous Total Nasal Symptom Score)

    4 weeks

Study Arms (3)

mometasone furoate + azelastin HCl

EXPERIMENTAL

opaque suspension, four times each naris per day

Drug: mometasone furoate plus azelastine HCl

mometasone furoate

ACTIVE COMPARATOR

opaque suspension, four times each naris per day

Drug: mometasone furoate

azelastine HCl

ACTIVE COMPARATOR

lucidus colorless liquid, two times each naris per day

Drug: azelastine HCl

Interventions

mometasone furoate plus azelastine HClDRUG
Also known as: Nasaflex Nasal Spray
mometasone furoate + azelastin HCl
mometasone furoateDRUG
Also known as: NASONEX NASAL SPRAY
mometasone furoate
azelastine HClDRUG
Also known as: AZEPTIN NASAL
azelastine HCl

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over 12 years of age
  • Medical history of perennial allergic rhinitis for at least two years
  • Moderate ro severe nasal symptom (during placebo run-in period AM rTNSS or PM rTNSS≥8)
  • Positive skin prick test result within the previous 12 months

You may not qualify if:

  • patients with active asthma that required therapy with inhaled or oral corticosteroids or long-term β-agonist
  • patients with severe rhinostenosis, severely deviated nasal septum or local infection on the nasal mucous membrane
  • patients with herpes zoster, glaucoma or cataract
  • patients with history of operation or damage on nasal cavity or ocular region
  • patients with drug-induced rhinitis
  • patients with history of respiratory infection which requires antibiotic therapy within the previous 14 days
  • Patients with lung disease including COPD
  • Patients with history of immunotherapy or ongoing immunotherapy
  • patients administered with super potent or potent corticosteroid
  • patients administered with intra-muscular or intra-articular steroid within the previous 3 months
  • patients administered with subcutaneous omalizumab within the previous 5 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Interventions

Mometasone Furoateazelastine

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Yang Gi Min, M.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2011

First Posted

November 11, 2011

Study Start

March 1, 2011

Primary Completion

December 1, 2011

Study Completion

November 1, 2012

Last Updated

August 27, 2013

Record last verified: 2011-11

Locations

KR(1)