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

NCT00783432 | Completed Phase 3 Results

• 1 other identifier: MP432
• Study Type: interventional
• Target: 862
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Number of Participants Reporting Adverse Events

  An AE can be any unfavorable and unintended sign,symptom, or disease temporally associated with the use of this investigational product, whether or not considered related to the investigational product. An AE is any untoward medical occurrence in a subject which does not necessarily have a causal relationship with this treatment.

  12 months

• Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.

  Examination of head and neck(scale: 0, 1+=Mild, 2+=Moderate, 3++Severe) for mucosal edema, nasal discharge, mucosal erythema, mucosal bleeding, mucosal ulcerations, crusting of mucosa, conjunctiva, tympanic membranes, lymph nodes of head and neck. Direct visual nasal examination (scale: None, Grade 2, Grade 3, and Grade 4) for epistaxis,ulceration and pain.

  baseline and 12 months/ET

Secondary Outcomes (1)

• Adult Mini-Rhinoconjuctivitis Quality of Life Questionnaire. Change From Baseline in RQLQ Score at Months 1,3,6,9 and 12/or Early Termination.

  baseline, months 1,3,6,9 and 12/or early termination

Study Arms (2)

1

EXPERIMENTAL

Astepro Nasal Spray (0.1% azelastine hydrochloride)

Drug: Astepro Nasal Spray (0.1% azelastine hydrochloride)

2

ACTIVE COMPARATOR

Astelin Nasal Spray (0.1% azelastine hydrochloride)

Drug: Astelin Nasal Spray (0.1% azelastine hydrochloride)

Interventions

Astepro Nasal Spray (0.1% azelastine hydrochloride) DRUG

548 mcg (2 sprays per nostril) twice a day

1

Astelin Nasal Spray (0.1% azelastine hydrochloride) DRUG

548 mcg (2 sprays per nostril) twice a day

2

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose (Splenda® brand sweetener)
• Women who are pregnant or nursing
• 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.
• Nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis,rhinitis medicamentosa or clinically significant nasal polyposis or nasal structural abnormalities
• Patients with asthma (with the exception of mild, intermittent asthma) or other significant pulmonary disease such as Chronic Obstructive Pulmonary Disease
• 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, might significantly alter the evaluation of study
• 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
• Study site staff, immediate relatives of study site staff, or other individuals who would have access to the clinical study protocol

Sponsors & Collaborators

• Meda Pharmaceuticals: lead

Study Sites (1)

Meda Clinical Trials Contact Center

Somerset, New Jersey, 08873, United States

Location

MeSH Terms

Interventions

azelastine

Results Point of Contact

• Title: William Wheeler, PhD
• Organization: Meda Pharmaceuticals

wwheeler@medapharma.us

732-564-2351

Study Officials

• Lewis M. Fredane, MD

  Meda Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 30, 2008
• First Posted: October 31, 2008
• Study Start: July 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: October 6, 2009
• Results First Posted: October 2, 2009

Record last verified: 2009-10

Locations

US (1)