EWO1 in Persistent Allergic Rhinitis Patients

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this double-blind, randomized, parallel group, placebo-controlled study is to assess the efficacy and safety of EWO1 in patients with moderate to severe perennial allergic rhinitis (AR).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China Medical University Hospital

Criteria

Inclusion Criteria:

1. Male or female patients, aged 12 years and above

2. AR confirmed by positive allergen (dust mite; Dp) specific IgE ≧ 2+ within 12 months of enrollment

3. History of persistent moderate to severe allergic rhinitis

4. One or more of the following: abnormal sleep; impairment of daily activities, sports, leisure; problems caused at work or school; and/or troublesome symptoms.

5. Total nasal symptom scores (nasal rhinorrhea, nasal congestion, nasal itching, sneezing and post-nasal drip) ≧ 5 at baseline period (scale 0 : none; 1 : mild; 2 : moderate; 3 : severe)

6. No initiation of immunotherapy within 6 months or no dose change in immunotherapy for 1 month

7. Signed informed consent obtained prior to inclusion into the study

Exclusion Criteria:

1. History of recent (within 6 months) asthma

2. Chronic or intermittent use of inhaled, oral, intramuscular (i.m.), intravenous (i.v.), and/or potent/superpotent topical steroids within 2 weeks

3. Use of prohibited medicines within 2 weeks

4. Use of long-acting antihistamines within 2 weeks

5. Documented evidence of acute or significant chronic sinusitis

6. Chronic use of concomitant medications that could interfere with assessment

7. Known or suspected hypersensitivity to any of the herbal components in EWO1

8. Rhinitis medicamentosa

9. Planned travel outside the study area for a substantial portion of time during the study

10. Use of another investigational product within the past 30 days

11. Pregnant or lactating women; women of child-bearing potential must use adequate contraception.

12. Renal dysfunction as evidenced by creatinine level of 1.5 x upper limit of normal (ULN)

13. Liver dysfunction as evidenced by SGPT of > 1.5 x ULN

14. Signs and symptoms of upper respiratory infection (URI) upon admission