Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Meda Pharmaceuticals
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
Clareo Health | A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Seasonal Allergies
