Status:
UNKNOWN
EWO1 in Persistent Allergic Rhinitis Patients
Lead Sponsor:
China Medical University Hospital
Conditions:
Rhinitis, Allergic, Perennial
Eligibility:
All Genders
12+ years
Phase:
PHASE2
PHASE3
Brief 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).
Detailed Description
Allergic rhinitis is a very common medical problem affecting adults and children alike. It has been estimated that 20% to 25% of the world's population suffer from allergic rhinitis, resulting in cons...
Eligibility Criteria
Inclusion
- Male or female patients, aged 12 years and above
- AR confirmed by positive allergen (dust mite; Dp) specific IgE ≧ 2+ within 12 months of enrollment
- History of persistent moderate to severe allergic rhinitis
- One or more of the following: abnormal sleep; impairment of daily activities, sports, leisure; problems caused at work or school; and/or troublesome symptoms.
- 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)
- No initiation of immunotherapy within 6 months or no dose change in immunotherapy for 1 month
- Signed informed consent obtained prior to inclusion into the study
Exclusion
- History of recent (within 6 months) asthma
- Chronic or intermittent use of inhaled, oral, intramuscular (i.m.), intravenous (i.v.), and/or potent/superpotent topical steroids within 2 weeks
- Use of prohibited medicines within 2 weeks
- Use of long-acting antihistamines within 2 weeks
- Documented evidence of acute or significant chronic sinusitis
- Chronic use of concomitant medications that could interfere with assessment
- Known or suspected hypersensitivity to any of the herbal components in EWO1
- Rhinitis medicamentosa
- Planned travel outside the study area for a substantial portion of time during the study
- Use of another investigational product within the past 30 days
- Pregnant or lactating women; women of child-bearing potential must use adequate contraception.
- Renal dysfunction as evidenced by creatinine level of 1.5 x upper limit of normal (ULN)
- Liver dysfunction as evidenced by SGPT of \> 1.5 x ULN
- Signs and symptoms of upper respiratory infection (URI) upon admission
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00153595
Start Date
November 1 2004
Last Update
July 25 2007
Active Locations (1)
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1
China Medical University Hospital
Taichung, Taiwan, 404