A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Perennial Allergies

Meda Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Perennial Allergic Rhinitis

Treatments: Drug: 0.1% azelastine hydrochloride; Drug: Placebo; Drug: 0.15% azelastine hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00712920

MP434

Details and patient eligibility

About

The purpose of this study is to determine if two allergy medications are more effective than placebo.

Enrollment: 581 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female patients 12 years of age and older
• Must be in generally good health
• Must meet minimum symptom requirements, as specified in protocol
• Must be willing and able to provide informed consent and participate in all study procedures
• 2-year history of PAR
• Positive skin test to cockroach, dust mite, mold or cat/dog dander

Exclusion criteria

• On nasal examination, presence of any nasal mucosal erosion, nasal ulceration or nasal septal perforation at the screening or randomization visit
• Nasal diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, significant polyposis or nasal structural abnormalities
• Nasal surgery or sinus surgery within the previous year
• The use of any investigational drug within 30 days
• Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose
• Women who are pregnant or nursing
• Women of child-bearing potential who are not abstinent and not practicing a medically acceptable method of contraception
• Respiratory tract infection within 2 weeks of screening
• Respiratory tract infections requiring oral antibiotic treatment within 2 weeks of screening
• Patients with asthma with the exception of mild, intermittent
• Significant pulmonary disease including COPD
• Patients with arrhythmia
• Patients with a known history of alcohol or drug abuse
• Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor may significantly alter the absorption, distribution, metabolism or excretion of study drug.
• Clinically relevant abnormal physical findings within one week of randomization
• Overnight abscences from home for more than 3 nights
• Employees of the research center or private practice and family members are excluded
• Patients who received prohibited medications within specified timepoints in protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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581 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

2

Experimental group

Description:

0.15% azelastine hydrochloride 1644 mcg/2 sprays per nostril 2 times a day for 4 weeks

Treatment:

Drug: 0.15% azelastine hydrochloride

3

Experimental group

Description:

0.1% azelastine hydrochloride 1096 mcg/2 sprays per nostril 2 times a day for 4 weeks

Treatment:

Drug: 0.1% azelastine hydrochloride