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OpenTrials
Completed

NCT Number: NCT01470053

Efficacy and Safety of Mometasone Furoate Plus Azelastine HCl Combination Versus Mometasone Furoate Alone or Azelastine Alone in Patients With Perennial Allergic Rhinitis

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

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

mometasone furoate plus azelastine HCl

Drug

Other names: Nasaflex Nasal Spray

Mometasone furoate

Drug

Other names: NASONEX NASAL SPRAY

azelastine Hcl

Drug

Other names: AZEPTIN NASAL

Primary outcomes

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

    Time frame: 4 weeks

Secondary outcomes

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

    Time frame: 4 weeks

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

    Time frame: 4 weeks

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

    Time frame: 4 weeks

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

    Time frame: 4 weeks

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

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Hanlim Pharm. Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind Phase Ⅲ Study of Mometasone Furoate/Azelastine Hydrochloride Combination Group and Mometasone Furoate and Azelastine Hydrochloride Group 4 Weeks After Treatment, Each Treatment Group Comparisons for Evaluation of Efficacy and Safety in Perennial Allergic Rhinitis Patient.

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Nov 11, 2011
Registry last updated
Aug 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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