None listed
Conditions
Brief summary
This study will evaluate the safety (i.e. incidence and type of adverse events) and efficacy (i.e. change from baseline in the 4 symptom nasal score for the entire double-blind treatment period) of CMP administered three times daily intranasally over a four week period to people with seasonal allergic rhinitis (SAR) as compared to placebo.
Interventions
Two sprays in each nostril of CMP 0.5% Nasal spray, three times a day for four weeks.
Sponsors
Anzamune Limited, NZ
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
15 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Subjects, male or female, must be between the ages of 15 to 60 years inclusive at the time of consent. A female of childbearing potential may be enrolled, provided she has a negative pregnancy test at Screening and is routinely using adequate contraception prior to and during the trial and agrees not to attempt to become pregnant during the trial. Subjects must give written informed consent prior to participation in the study and must understand the purpose of this study and be willing to adhere to the treatment regimen and study procedures described in this protocol. Subjects must have a documented history of SAR for at least 2 years prior to the Screening Visit against pollen from the geographical area of the study site, as diagnosed by the Investigator or another physician. Subjects must have a documented sensitivity to one or more of the relevant seasonal allergens for the geographical area by an allergy skin test (prick) performed within the last 12 months of Visit 1. If this is not available it must be performed at Visit 1 At Visit 1 the subjects must have an average score of at least 1.5 in the 4 symptom nasal score. At Visit 2 the subjects must have an average score of at least 1.5 in the 4 symptom nasal score calculated from the assessments documented in the diary during the last 3 days (including the assessment in the morning before Visit 2). The subject must show symptoms of seasonal allergic rhinitis at Visit 2.
Exclusion criteria
Subjects with a known sensitivity to chitin, shellfish or any of the excipients in the study drug formulation. Subjects who have used an investigational drug within 30 days prior to screening, or who are currently participating in another clinical study. Subjects with a current or past history (within the last 12 months) of alcohol or drug abuse. Subjects with a history of asthma, with the exception of mild intermittent asthma (per the 1997 National Asthma Education and Prevention Program (NAEPP) guideline on asthma severity scale) Documented evidence of acute or significant chronic sinusitis, as determined by the investigator. Subject with perennial allergic rhinitis who has symptoms throughout the year defined as symptomatic on more than 50% of days during the last year as self reported by the subject. Subjects who have any clinically significant abnormal physical examination or laboratory results that, in the opinion of the Investigator, would put the subject at increased risk by participation in the study. Subjects who have received a vaccination within 30 days prior to the screening visit or who intend to receive a vaccination during the study. Subjects with congenital or acquired immunodeficiency including subjects known to be positive for Human Immunodeficiency Virus (HIV). Subjects on chronic anti inflammatory or immunosuppressive therapy, with chronic autoimmune or inflammatory disease or with otherwise compromised immune system. Subjects who have a medical condition which, in the opinion of the Investigator, would put the subject at increased risk by participation in the study or prevent them from completing the study, e.g. history or current confirmation of clinical abnormality of the hepatic or renal system. Subjects who have received any of the following medications, within the time frame specified prior to screening (Visit 1), or are likely to require these medications during the study. Within two years to screening: Any anti-allergy immunotherapy (desensitizing subjects with increase of allergen challenge) Within one month prior to screening: Chronic or intermittent use of inhaled, oral, intramuscular, intravenous, and/or potent or super-potent topical corticosteroids Long acting anti-histamines HIV protease inhibitors (ritonavir, indinavir, saquinavir, nelfinavir); Potent inhibitors of P450 cytochrome CYP 3A4 Within seven days prior to screening: Cetirizine, fexofenadine HCL, all other antihistamines (includes sleep and diet aids and cold preparations).
Outcome results
None listed