Study to Evaluate the Safety and Tolerability of a Nasal Spray in Patients With Chronic Allergic or Nonallergic Rhinitis

NCT ID: NCT00783432

Last Updated: 2009-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 862 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2007-12-31

Brief Summary

The purpose of this study is to determine if Astepro Nasal Spray (0.1% azelastine hydrochloride) is as safe as Astelin Nasal Spray (0.1% azelastine hydrochloride)

Conditions

Chronic Allergic Rhinitis; Nonallergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Astepro Nasal Spray (0.1% azelastine hydrochloride)

Group Type: EXPERIMENTAL

Astepro Nasal Spray (0.1% azelastine hydrochloride)

Intervention Type: DRUG

548 mcg (2 sprays per nostril) twice a day

2

Astelin Nasal Spray (0.1% azelastine hydrochloride)

Group Type: ACTIVE_COMPARATOR

Astelin Nasal Spray (0.1% azelastine hydrochloride)

Intervention Type: DRUG

548 mcg (2 sprays per nostril) twice a day

Interventions

Astepro Nasal Spray (0.1% azelastine hydrochloride)

548 mcg (2 sprays per nostril) twice a day

Intervention Type: DRUG

Astelin Nasal Spray (0.1% azelastine hydrochloride)

548 mcg (2 sprays per nostril) twice a day

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male and female patients 12 years of age and older with an established history (> 1 year) of rhinitis due to perennial allergies, non-allergic triggers or vasomotor rhinitis (VMR).

2. Provide written informed consent/pediatric assent. If the patient is a minor, a parent or legal guardian must give written informed consent

3. Willing and able to comply with the study requirements, including daily use of medication for a one year period, even if symptoms are not bothersome.

4. General good health and free of any disease or concomitant treatment that could interfere with the interpretation of the study results as determined by the investigator or the sponsor's medical officer

5. Patients receiving immunotherapy (antigen desensitization) must be on a stable maintenance regimen for at least 30 days before the first study visit (adjustments to regimen following a brief period of missed injections does not preclude participation)

Exclusion Criteria

1. The use of any investigational drug within 30 days prior to screening. No other investigational products are permitted for use during the conduct of this study

2. Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose (Splenda® brand sweetener)

3. Women who are pregnant or nursing

4. Women of childbearing potential who are not abstinent and not practicing a medically acceptable method of contraception. Female patients must practice an acceptable contraceptive technique for 30 days before randomization and agree to continue its use during treatment and for 30 days after the last dose of study drug. Oral, intrauterine, implantable, injectable contraceptives, or a double barrier form of contraception are acceptable and the medication including dose, device or method must have been stable for at least 30 days before the first dose of study drug.

5. Nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis,rhinitis medicamentosa or clinically significant nasal polyposis or nasal structural abnormalities

6. Patients with asthma (with the exception of mild, intermittent asthma) or other significant pulmonary disease such as Chronic Obstructive Pulmonary Disease

7. Patients with a known history of alcohol or drug abuse

8. Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor, might significantly alter the evaluation of study

9. Clinically relevant abnormal history and/or physical findings which, in the opinion of the investigator or sponsor, would interfere with the objectives of the study or that may preclude compliance with the study procedures

10. Study site staff, immediate relatives of study site staff, or other individuals who would have access to the clinical study protocol

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meda Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Vice President, Medical and Scientific Affairs

Principal Investigators

Lewis M. Fredane, MD

Role: STUDY_DIRECTOR

Meda Pharmaceuticals

Locations

Meda Clinical Trials Contact Center

Somerset, New Jersey, United States

Countries

United States

Other Identifiers

MP432

Identifier Type: -

Identifier Source: org_study_id