EWO1 in Persistent Allergic Rhinitis Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by China Medical University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT00153595
First received: September 8, 2005
Last updated: July 23, 2007
Last verified: September 2005
  Purpose

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 Intervention Phase
Rhinitis, Allergic, Perennial
Drug: EWO1
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized Parallel Group, Placebo-Control Study of EW01 in Persistent Allergic Rhinitis (PAR) Patients

Further study details as provided by China Medical University Hospital:

Estimated Enrollment: 60
Study Start Date: November 2004
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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00153595

Contacts
Contact: Min-Chien Yu, Ph.D. 886-4-22052121 ext 5068 yu7777c@yahoo.com.tw

Locations
Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan, 404
Contact: Min-Chien Yu, Ph.D.    886-4-22052121 ext 5068    yu7777c@yahoo.com.tw   
Principal Investigator: Min-Chien Yu, Ph.D.         
Sponsors and Collaborators
China Medical University Hospital
Investigators
Principal Investigator: Min-Chien Yu, Ph.D. China Medical University Hospital, Taiwan
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00153595     History of Changes
Other Study ID Numbers: DMR93-IRB-90, DOH93-TD-I-1-1-1-006
Study First Received: September 8, 2005
Last Updated: July 23, 2007
Health Authority: Taiwan: Department of Health

Keywords provided by China Medical University Hospital:
Allergic rhinitis
EWO1

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

ClinicalTrials.gov processed this record on July 09, 2014