EWO1 in Persistent Allergic Rhinitis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00153595
Recruitment Status : Unknown
Verified September 2005 by China Medical University Hospital.
Recruitment status was:  Recruiting
First Posted : September 12, 2005
Last Update Posted : July 25, 2007
Information provided by:
China Medical University Hospital

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).

Condition or disease Intervention/treatment Phase
Rhinitis, Allergic, Perennial Drug: EWO1 Phase 2 Phase 3

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 considerable morbidity - impaired quality of life. In the U.S., there is an estimated $2.4 billion annual medical cost associated with allergic rhinitis.

In Taiwan, household dust mites (HDM) are primary allergens causing allergic reactions including allergic rhinitis. The incidence of HDM in Taiwan can be as high as 100%. Df, Dp and Blomia tropicalis (Bt) rank among the top 3 most common household dust mites. Antihistamines remain a major therapy for treatment of allergic rhinitis. Chinese herbs have long been used to treat different allergic and immunologic diseases. YU-PING-FENG-SAN (YPFS) with a formulation that contains 3 herbs [Huangqi (HQ), baizhu (BZ), and fangfeng (FF)] has been reported as one of the effective traditional Chinese medicines for the treatment of recurrent rhinitis.

In 3 previous non-placebo controlled clinical studies in perennial rhinitis, it has been demonstrated that by adding Xingyi(XY) to a YPFS formula with CQ, BZ, and FF, additional efficacy benefits can be obtained.

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. After a 2-week placebo run-in period, patients who satisfy all of the inclusion/exclusion criteria will be randomized 1:1 to receive either EWO1, or placebo for 28 days. After the treatment-period, patients will be followed for 14 days to see if there is any rebound in rhinitis symptoms. The Primary efficacy endpoint is weekly combined symptom scores at the end of treatment. Besides, intent to treat analyses will be carried out for both efficacy and safety. A minimum of 60 patients will be randomized into this two-treatment parallel-design study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized Parallel Group, Placebo-Control Study of EW01 in Persistent Allergic Rhinitis (PAR) Patients
Study Start Date : November 2004

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00153595

Contact: Min-Chien Yu, Ph.D. 886-4-22052121 ext 5068

China Medical University Hospital Recruiting
Taichung, Taiwan, 404
Contact: Min-Chien Yu, Ph.D.    886-4-22052121 ext 5068   
Principal Investigator: Min-Chien Yu, Ph.D.         
Sponsors and Collaborators
China Medical University Hospital
Principal Investigator: Min-Chien Yu, Ph.D. China Medical University Hospital,Taiwan Identifier: NCT00153595     History of Changes
Other Study ID Numbers: DMR93-IRB-90
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: July 25, 2007
Last Verified: September 2005

Keywords provided by China Medical University Hospital:
Allergic rhinitis

Additional relevant MeSH terms:
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases