Safety and Tolerability of a nasal spray in patients with Chronic allergic or nonallergic rhinitis

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12606000348550
• Date of registration: 14/08/2006
• Prospective Registration: No
• Primary sponsor: MedPointe Pharmaceuticals
• Public title: Safety and Tolerability of a nasal spray in patients with Chronic allergic or nonallergic rhinitis
• Scientific title: Active-Controlled Trial of the Safety and Tolerability of MP03-33 (Nasal Spray) in Patients with Chronic Allergic or Nonallergic Rhinitis
• Date of first enrolment: 21/07/2006
• Target sample size: 800
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12606000348550.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety;
• Phase: Phase 3

Countries of recruitment

Australia

Contacts

• Name: Dr Richard Spivey (Director)

• Name: Dr Richard Spivey (Director)

Key inclusion & exclusion criteria

Inclusion criteria: a. An established history (> 1 year) of rhinitis due to perennial allergies, non-allergic triggers or vasomotor rhinitis (VMR). Patients with a seasonal allergic component may also be included, provided that they have had significant symptoms outside the allergy seasons. b. Provide written informed consent/pediatric assent. If the patient is a minor, a parent or legal guardian must give written informed consent.c. 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.d. 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.e. 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: a. 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.b. Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose (Splenda® brand sweetener)c. Women who are pregnant or nursing.d. 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. e. Nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa or clinically significant nasal polyposis or nasal structural abnormalities.f. Patients with asthma (with the exception of mild, intermittent asthma) or other significant pulmonary disease such as Chronic Obstructive Pulmonary Disease.g. Patients with a known history of alcohol or drug abuse.h. Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor, might significantly alter the evaluation of study.i. 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.j. Study site staff, immediate relatives of study site staff, or other individuals who would have access to the clinical study protocol.

Age minimum: 12 Years
Age maximum: Not stated
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Inflammatory and Immune System - Allergies

chronic allergic or nonallergic rhinitis;
chronic allergic or nonallergic rhinitis

Intervention(s)

The objective of this study is to evaluate the safety and tolerability of MP03-33 with chronic use (two sprays morning and evening) over a 1-year period in patients with chronic allergic or nonallergic rhinitis.

Primary Outcome(s)

Direct visual examination of the nasal mucosa with specific attention to possible nasal irritation.[Performed by investigative site at office visit]

Safety and tolerability as measured by the frequency of patient reported adverse events. [At 1 year]

Secondary Outcome(s)

Adherence to therapy as measured by the daily diary card. [1yr]

Efficacy as measured by mini-Rhinitis Quality of Life Questionnaire ( mini-RQLQ).[]

Secondary ID(s)

Medpointe Pharmaceuticals: Clinical Protocol 432

Source(s) of Monetary Support

MedPointe Pharmaceuticals