A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Seasonal Allergies

Completed · Phase 3 · Has a placebo group

Conditions studied: Seasonal Allergic Rhinitis

In brief

The Purpose of this study is to evaluate the safety and efficacy of MP03-36 (0.15% azelastine hydrochloride)at dosages of 2 sprays per nostril once daily and 2 sprays per nostril twice daily in patients with seasonal allergic rhinitis.

Key facts

Study ID

NCT01368445

Run by

Meda Pharmaceuticals

People needed

617

Starts

2006-08-01

Expected to finish

2008-04-01

Last updated by the study team

2011-10-06

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female patients 12 years of age and older
• Provide written informed consent/pediatric assent. If the patient is a minor, a parent or legal guardian must give written informed consent
• Screening Visit: Have a 12-hour reflective total nasal symptoms score ( TNSS) of at least 8 out of a possible 12 and a congestion score of 2 or 3 on Day -7
• Randomization Visit: Have a 12-hour reflective total nasal symptoms score (TNSS) (AM or PM) of at least 8 on 3 separate assessments (one of which was within 2 days of Day 1, and can include the morning of Day 1) during the Lead-in Period. In addition, an AM or PM nasal congestion score of 2 or 3 must have been recorded on 3 separate assessments (one of which was within 2 days of Day 1, and can include the morning of Day 1).
• Must have taken at least 10 doses of study medication during the lead-in period
• Randomization Visit: An instantaneous (TNSS) of ≥ 8 before beginning the onset of action assessment on Day 1
• Willing and able to comply with the study requirements
• At least a 2-year history of seasonal allergic rhinitis (SAR) during the fall pollen allergy season
• The presence of IgE-mediated hypersensitivity to local fall pollen confirmed by a positive response to either skin prick or intradermal testing within the last year. A positive response is defined as a wheal diameter of at least 3 mm larger than the control for the skin prick test or at least 7 mm larger than the control for the intradermal test.
• 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 injections (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). Patients who are on maintenance doses of sublingual immunotherapy may be considered for the trial on a case-by-case basis after discussion with the sponsor's medical monitor or designee.

You may not qualify if…

• The use of any investigational drug within 30 days prior to Day -7. No 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
• Respiratory tract infections within two weeks prior to Day -7
• Respiratory Infections requiring oral antibiotic treatment two weeks prior to Day -7
• Other nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa or clinically significant polyposis or nasal structural abnormalities
• Patients with asthma (with the exception of mild, intermittent asthma)
• Patients with significant 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 absorption, distribution, metabolism, or excretion of study drug
• Clinically relevant abnormal physical findings within 1 week of randomization which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures
• Planned travel outside the study area during the study period
• Family members and employees should be excluded
• Patients who received prohibited medications within specified timepoints in the protocol.

Where it is running

• AABI Associates Medical Group — Fountain Valley, California, United States
• West Coast Clinical Trials — Long Beach, California, United States
• Allergy Research Foundation — Los Angeles, California, United States
• Southern California Research — Mission Viejo, California, United States
• Allergy Medical Group — Roseville, California, United States
• Allergy Associates Medical Group — San Diego, California, United States
• Allergy and Asthma Associates of CA — San Jose, California, United States
• The William Storms Allergy Clinic — Colorado Springs, Colorado, United States
• Colorado Allergy and Asthma Centers, PC — Denver, Colorado, United States
• Coastal Allergy and Asthma P.C. — Savannah, Georgia, United States
• Kansas City Allergy and Asthma — Overland Park, Kansas, United States
• Institute for Asthma and Allergy, P.C. — Wheaton, Maryland, United States
• Northeast Medical Research Associates, Inc. — North Dartmouth, Massachusetts, United States
• Clinical Research Institute — Minneapolis, Minnesota, United States
• The Asthma and Allergy Center, PC — Papillion, Nebraska, United States
• Atlantic Allergy, Asthma & Immunology — Ocean City, New Jersey, United States
• Princeton Center for Clinical Research — Skillman, New Jersey, United States
• Allergy and Asthma Institue of Rochester — Rochester, New York, United States
• North Carolina Clinical Research — Raleigh, North Carolina, United States
• Clinical Research Center — Cincinnati, Ohio, United States
• Oklahoma Institute of Allergy and Asthma — Edmond, Oklahoma, United States
• Allergy and Asthma Consultants of NJ-PA, P.C — Collegeville, Pennsylvania, United States
• Valley Clinical Research Center — Easton, Pennsylvania, United States
• Allergy and Clinical Immunology Associates — Pittsburgh, Pennsylvania, United States
• Allergy Asthma Associates Research Dept. — Austin, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.