RecruitingPhase 3ACTRN12606000348550

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

Active-Controlled Trial of the Safety and Tolerability of MP03-33 (Nasal Spray) in Patients with Chronic Allergic or Nonallergic Rhinitis


Sponsor

MedPointe Pharmaceuticals

Enrollment

800 participants

Start Date

Jul 21, 2006

Study Type

Interventional

Conditions

Summary

The objective of this study is to evaluate the long-term safety and tolerability of MP03-33, a nasal spray,over a 1-year period in patients with chronic allergic or nonallergic rhinitis. Commercially available azelastine hydrochloride nasal spray will serve as an active control.


Eligibility

Sex: Both males and femalesMin Age: 12 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a new nasal spray called MP03-33 over a full year to see if it is safe and well-tolerated in people who have long-term nasal allergy symptoms or non-allergic runny nose and congestion. These symptoms can be caused by dust mites, pet dander, or other triggers that affect people year-round. An existing approved nasal spray (azelastine) will be used as a comparison. Participants will use the spray daily for 12 months, and their safety will be monitored throughout. You may be eligible if: - You are 12 years of age or older - You have had nasal allergy symptoms or non-allergic rhinitis for more than 1 year - Your symptoms occur year-round (not only during a specific pollen season) - You are in generally good health - You are able and willing to use the nasal spray every day for 12 months You may NOT be eligible if: - You are pregnant or breastfeeding - You are a woman of childbearing age who is not using reliable contraception - You are allergic to azelastine or to sorbitol or sucralose - You have nasal polyps, chronic sinusitis, or a significant structural problem in your nose - You have moderate to severe asthma or a major lung condition - You have a history of alcohol or drug abuse Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 nonallergi

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.


Locations(1)

Australia

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ACTRN12606000348550