Table 3 Proposed Consensus Criteria for an Efficacy Study of Therapy for Nonallergic Rhinopathy (Referred to in This Table as NAR)

Inclusion: Subjects should meet all criteria listed below:

   1. Diagnosis of non-allergic rhinopathy (NAR) as defined to include all of the following:

a. Two year clinical history of NAR symptoms, including nasal congestion, nasal discharge, and post-nasal drip

b. Chronic, perennial nature of symptoms with fluctuation/exacerbation related to one or more triggers including: cold air, changes in climate (temperature, humidity, barometric pressure), strong smells (such as perfume, cooking smells, flowers, chemical odors), exposure to environmental tobacco smoke, changes in sexual hormones levels, exposure to pollutants and chemicals (e.g. volatile organics), abnormal nasal response to exercise or alcohol ingestion.

c. Negative skin prick tests to seasonal allergens (e.g., trees, grass, weed, etc) and perennial allergens (e.g., animal dander, house dust mite, cockroach, etc). Negative test defined as a wheal < 3 mm larger than the diluent control or negative serum specific IgE antibody levels.

d. Positive response to histamine skin prick test. Positive test defined as wheal ≥ 3 mm larger than the diluent control.

e. Normal sinus radiograph (Waters view or CT) to rule out sinusitis

   2. Nasal cytology negative for eosinophils to rule out NARES (less than 5% of total cells)

   3. Informed consent: Appropriately signed and dated informed consent for study subjects ages 18 years and older. For study subjects ages less than 18 years, informed consent signed by parents or care providers

   4. Subjects are able, willing, and likely to comply with study procedures and restrictions

   5. Subjects can be treated on outpatient basis

   6. Age 12 years or older

   7. Female of childbearing potential must commit to using acceptable method of birth control [method may vary depending on marketing status and teratogenicity potential]

   8. Subjects literate enough to read, understand, and record information in native language (or language that will be used in the study procedure)

Exclusion: Subjects will not be eligible for inclusion if any of the following criteria is met:

   1. Significant concomitant medical condition defined as but not limited to:

a. History or current evidence of clinically significant disease of any body system that in the opinion of the investigator would put the safety of the study subjects at risk through participation in the study, or would confound the interpretation of the study results.

b. Significant anatomical nasal disease such as physical obstruction of the nose, substantial deviated nasal septum, or nasal septal perforation that could affect the deposition of intranasal study drug and interfere with interpretation of medication outcomes. Rhinitis medicamentosa

c. Common cold or any bacterial or viral infection of the upper respiratory tract for 14 days prior to screening period

d. Documented acute or chronic sinusitis, as determined by Waters view or CT scan

e. Physical impairment that would affect subject's participation in the study

f. History of psychiatric disease, intellectual deficiency, poor motivation, substance abuse, alcohol abuse, cocaine use, or other conditions that would limit the validity of the informed consent, or confound the interpretation of the study

g. Use of intranasal, inhaled, oral, intravenous, intramuscular, ocular, or dermatologic corticosteroid for 30 days prior to screening period

   2. Use of other drugs for allergic diseases in the timeframe of the screening period

a. Intranasal or ocular cromolyn within 14 days

b. OTC or prescription antihistamines by any route, including topical within 14 days

c. Oral or nasal decongestants within 3 days

d. Oral, nasal, or inhaled anticholinergics within 3 days

e. Antileukotrienes within 3 days

f. Any immunosuppressants for 6 months

g. Cough and cold lozenges or throat sprays within 3 days

   3. Patients likely to use any drugs listed in items 2 above during treatment period

   4. Use of drugs likely to affect NAR or its symptoms, such as, but not limited to, tricyclic antidepressants, long-acting beta-agonists, any intranasally administered medication

   5. Chronic use of drugs that can cause rhinitis or rhinitis type symptoms, such as, but not limited to, ACE inhibitors, reserpine, guanethidine, methyldopa, hydralazine, beta-blockers, alpha-adreneceptor antagonists, phentolamine, chlorpromazine, aspirin, NSAIDs

   6. Use of botanical agents or dietary supplements

   7. Allergen immunotherapy

   8. Breastfeeding females

   9. Positive or inconclusive pregnancy test for females

   10. Any affiliation with study investigator or investigational site

   11. Tobacco use within one year of the study participation or a total of 10 pack years of use in the past.

   12. Use of any investigational or experimental medicine within 30 days

   13. Clinically significant abnormality in any clinical laboratory parameter, ECG, urinalysis, or physical examination finding

   14. Drug specific exclusion criteria, [for example, for nasal corticosteroids, these would include candida infection of the nose or upper airway, ocular herpes simpex, glaucoma, cataract, shingles, chicken pox, measles, adrenal insufficiency, etc.]