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

Hanlim Pharm

Status and phase: Completed; Phase 3

Conditions: Perennial Allergic Rhinitis

Treatments: Drug: mometasone furoate plus azelastine HCl; Drug: azelastine HCl; Drug: mometasone furoate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01470053

HL_NSFX_301

Details and patient eligibility

About

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

Enrollment: 347 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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347 participants in 3 patient groups

mometasone furoate + azelastin HCl

Experimental group

Description:

opaque suspension, four times each naris per day

Treatment:

Drug: mometasone furoate plus azelastine HCl

mometasone furoate

Active Comparator group

Description:

opaque suspension, four times each naris per day

Treatment:

Drug: mometasone furoate

azelastine HCl

Active Comparator group

Description:

lucidus colorless liquid, two times each naris per day

Treatment:

Drug: azelastine HCl