Rhinitis, Allergic, PerennialPhase 2/3NCT00153595
EWO1 in Persistent Allergic Rhinitis Patients
A Phase 2/3 study testing EWO1 in people with Rhinitis, Allergic, Perennial, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Rhinitis, Allergic, Perennial
- What is being tested?
- EWO1
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2004to not given
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, 404
Min-Chien Yu, Ph.D., 886-4-22052121 ext. 5068, yu7777c@yahoo.com.tw
Min-Chien Yu, Ph.D.
About this study
Official title: A Double-Blind, Randomized Parallel Group, Placebo-Control Study of EW01 in Persistent Allergic Rhinitis (PAR) Patients
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).
Read the 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.
- Conditions
- Rhinitis, Allergic, Perennial
- Being tested
- EWO1
- Keywords
- Allergic rhinitis, EWO1
- Medical subject headings
- Rhinitis, Allergic, Perennial, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EWO1Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, Allergic, PerennialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Min-Chien Yu, Ph.D., Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153595
- Sponsor's protocol ID
- DMR93-IRB-90
- Other IDs
- DOH93-TD-I-1-1-1-006
- Status last verified
- Sep 2005
- First submitted
- 8 Sep 2005
- Last updated
- 25 Jul 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized Parallel Group, Placebo-Control Study of EW01 in Persistent Allergic Rhinitis (PAR) Patients
- ClinicalTrials.gov ID
- NCT00153595
- Acronym / sponsor ID
- DMR93-IRB-90
- Conditions
- Rhinitis, Allergic, Perennial
- Keywords
- Allergic rhinitis, EWO1
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Nov 2004
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EWO1 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min-Chien Yu, Ph.D. principal investigator
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing EWO1 in people with Rhinitis, Allergic, Perennial, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min-Chien Yu, Ph.D. (886-4-22052121 ext. 5068, yu7777c@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2007.