A Pilot Study In Adults And Adolescents With Irritant (Non-Allergic) Rhinitis

Inclusion Criteria

• Informed consent: Subject is willing and able to provide consent to participate in the study. For subjects who are under 18 years of age, an appropriately signed and dated assent must be obtained from the parents or guardian.
• Outpatient: Subject is treatable on an outpatient basis.
• Age: 12 years of age or older at Visit 2.
• Gender: Male or eligible female

To be eligible for entry into the study, females of childbearing potential must commit to the consistent and correct use of an acceptable method of birth control, as defined by the following:

• Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject
• Implants of levonorgestrel
• Injectable progestogen
• Oral contraceptive (either combined estrogen/progestin or progestin only)
• Any intrauterine device (IUD) with a documented failure rate of less than 1% per year, or
• Females of childbearing potential who are not sexually active must commit to complete abstinence from intercourse for two weeks before exposure to the study drug, throughout the clinical trial, and for a period after the trial to account for elimination of the drug (minimum of six days).
• Double barrier method - spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or a spermicide and female diaphragm).

Female subjects should not be enrolled if they plan to become pregnant during the time of study participation. A urine pregnancy test will be performed at the screening visit (Visit 1), the randomisation visit (Visit 2) and at the final visit (Visit 6 or Early Withdrawal).

• Clinical history: Diagnosis or evidence of air pollution triggers as the predominant irritant trigger for their rhinitis symptoms to include ALL of the following:
• A two year clinical history of irritant (non-allergic) rhinitis triggered predominantly by air pollution exposure (written or verbal confirmation) in the opinion of the investigator and evidence of symptoms such as rhinorrhea, nasal congestion and postnasal drip relating to concentration of air particulates, air quality and levels of exposure.
• Based on the trigger questionnaire, subjects must indicate that air pollution is the predominant trigger that makes their rhinitis symptoms worse completed at Visit 1.
• Negative skin test (by prick method) response to seasonal allergens (including tree, grass and weed pollens) and perennial allergens (including animal dander, house dust mites, cockroach and mould) relevant to the geographical area completed at Visit 1.

A negative response for allergen skin prick testing is defined as a wheal <3 mm than the diluent control.

• Positive response to a histamine skin test (prick method) completed at Visit 1. A positive response for histamine skin prick testing is defined as a wheal ≥3 mm larger than the diluent control.
• Normal sinus radiograph (Waters view) to rule out sinusitis (presence of mucosal thickening of ≥6 mm at the point of maximal thickening or an air fluid level or opacification). The sinus radiograph will be scheduled at Visit 1.
• Ability to comply with study procedures: Subject understands and is willing, able and likely to comply with study procedures and restrictions.
• Literate: Subject must be able to read, comprehend, and record information in English or native language.

Randomization Criteria

• Average of the last 8, reflective, total nasal symptom score (rTNSS) assessments (4 morning [AM] assessments, 4 evening [PM] assessments) over the four 24-hour periods prior to randomisation must be greater than/equal to 4.5.
• Average of the last 8 reflective nasal symptom assessments for congestion (4 AM assessments, 4 PM assessments) over the four 24-hour periods prior to randomisation must be greater than/equal to 2.
• A subject must have completed 80% of assessments on the screening symptom diary card.

Exclusion Criteria

• Significant concomitant medical conditions, defined as but not l