NCT00153595

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

July 25, 2007

Status Verified

September 1, 2005

First QC Date

September 8, 2005

Last Update Submit

July 23, 2007

Conditions

Rhinitis, Allergic, Perennial

Keywords

Allergic rhinitisEWO1

Interventions

EWO1DRUG

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

RECRUITING

MeSH Terms

Conditions

Rhinitis, Allergic, PerennialRhinitis, Allergic

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Min-Chien Yu, Ph.D.

    China Medical University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Min-Chien Yu, Ph.D.

CONTACT

886-4-22052121yu7777c@yahoo.com.tw

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

November 1, 2004

Last Updated

July 25, 2007

Record last verified: 2005-09

Locations

TW(1)