StahistRx Phase 2, Five-arm, Parallel Group, Active vs Active, Double-blind Study

Actives in each of the five study arms:

Pseudoephedrine 120 mg/Chlorpheniramine 8 mg/Atropine 0.36 mg Pseudoephedrine 120
mg/Chlorpheniramine 8 mg/Atropine 0.24 mg Pseudoephedrine 120 mg/Chlorpheniramine 8
mg/Atropine 0.12 mg Pseudoephedrine 120 mg/Chlorpheniramine 8 mg Atropine 0.24 mg

Inclusion Criteria:

1. Male and females of any ethnic group between 12 and 60 years of age.

2. History of moderate to severe SAR for at least two years; defined as having a score
of 2 or more on a 0-3 point scale

3. Documentation of sensitivity will be obtained from medical records or positive skin
testing or in vitro specific IgE test.

4. Have a TNSS score of 6 with at least an average of 2.0 in the rhinorrhea sub-score
during the placebo-run in phase.

5. Is a non-pregnant, non-lactating female who is postmenopausal, naturally or
surgically sterile, or who agree to use effective contraceptive methods throughout
the course of the study.

6. If female of childbearing potential, must agree to use listed acceptable birth
control methods...

7. If female of childbearing potential, has a negative urine human chorionic
gonadotropin (hCG) pregnancy test at screening

8. Is able to swallow whole tablets of orally administered medication

9. Is able to understand and provide signed informed consent

Exclusion Criteria:

1. Has asthma requiring corticosteroid treatment

2. Is currently undergoing chronic or intermittent use of inhaled, oral, intramuscular,
intravenous, and/or potent or super potent topical corticosteroids

3. Has taken any of the following medications in the indicated time period prior to
study enrolment:

- Intranasal, opthalmic, or systemic corticosteroids (1 month)

- Intranasal cromolyn (2 weeks)

- Intranasal or systemic decongestants (3 days)

- Intranasal or systemic antihistamines (7 days) or leukotriene inhibitors (7
days)

4. Documented evidence of acute or significant chronic sinusitis, as determined by the
individual investigator

5. Has a history of allergic reaction to or known sensitivity to the active or inactive
ingredients in the investigational products used in this study

6. Chronic use of concomitant medications (e.g., tricyclic antidepressants) that would
affect assessment of the effectiveness of the study medication

7. Rhinitis medicamentosa

8. A history of glaucoma

9. Has known or suspected pregnancy, planned pregnancy, or lactation (for female
patients)

10. Is currently receiving immunotherapy, unless at stable maintenance dose for at least
1 month.

11. Presence of a medical condition that might interfere with treatment evaluation or
require a change in therapy.

12. Plans to travel outside the study area for a substantial portion of the study period

13. Has a history in the last 2 years or current evidence of abuse of illicit drugs,
prescription medications, or alcohol that, in the opinion of the Investigator, would
interfere with adherence to study requirements.

14. Has exposure to any investigational agent within 30 days prior to study entry.

15. Has clinically significant mental illness (to be determined by the Investigator)

16. Has a condition the Investigator believes would interfere with the ability to provide
informed consent or comply with study instructions, or that might confound the
interpretation of the study results or put the patient at undue risk