Eosinophilic EsophagitisPhase 3NCT01702701
Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone
A Phase 3 study testing Montelukast and Fluticasone in people with Eosinophilic Esophagitis and Dysphagia, run by Medical College of Wisconsin at 2 sites in United States.
Trial summary
This study will compare response to treatment of Eosinophilic Esophagitis with montelukast vs standard therapy fluticasone. Investigators hypothesize that montelukast is equally effective in treating symptoms and histology of EoE when compared to fluticasone. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eosinophilic Esophagitis, Dysphagia
- What is being tested?
- Montelukast and Fluticasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2012to 20 Jul 2017
- Phase
- Phase 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with a confirmed diagnosis of EoE on biopsy
- with >15 eos per HPF
- ages >18
- Both male and Female.
- Not pregnant
Who cannot join
- pregnancy
- patients receiving ongoing medical therapy for EoE
- patients who underwent dilation in the last 12 weeks with improvement in symptoms
- LA grade B or worse erosive esophagitis.
- age < 18
- nursing mothers
- use of prohibited concomitant medications : budesonide-oral compounded liquid, fluticasone or montelukast.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
GI Associates
Milwaukee, Wisconsin, 53226
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
This study will compare response to treatment of Eosinophilic Esophagitis with montelukast vs standard therapy fluticasone. Investigators hypothesize that montelukast is equally effective in treating symptoms and histology of EoE when compared to fluticasone. The study will be conducted at multiple sites with Medical College of Wisconsin as the coordinating site. After identification and recruitment all patients will be randomized (provider blinded) to one of two medications: montelukast 10mg po qday vs fluticasone 440mcg po bid. Patients will also complete a pretreatment, 6 week therapy and 12 week therapy questionaire. They will then undergo a repeat endoscopy to evaluate endoscopic and histologic response.
Read the detailed description
Eosinophilic esophagitis is an allergic condition of the esophagus with an incidence that is on the rise, and has limited treatment options. Current gold standard of treatment is with topical steroids (swallowed fluticasone). There is preliminary data that oral montelukast may prove to be effective in inducing and maintaining symptomatic along with histologic remission of this disease. Investigators will be comparing the effectiveness of singulair to swallowed fluticasone in inducing and maintaining histologic and symptomatic remission of eosinophilic esophagitis.
- Conditions
- Eosinophilic Esophagitis, Dysphagia
- Being tested
- Montelukast, Fluticasone
- Medical subject headings
- Eosinophilic Esophagitis, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
Also called Singulair
montelukast 10mg po pill q day for 12 weeks
FluticasoneDrug
Also called Flovent
fluticasone 440mcg po q bid x 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Montelukast | Active comparator | patients will receive 10 mg po montelukast daily for 12 weeks. Receives: Drug: Montelukast |
| Fluticasone | Active comparator | patients will receive 440mcg fluticasone po bid for 12 weeks Receives: Drug: Fluticasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Dysphagia symptom score
Measured: 3 month
Secondary outcomes (1)
Improvement in esophageal histology counts of eosinophils/hpf
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2012 (estimated)
- Study startJan 2012
- Primary completion20 Jul 2017
- Study completion20 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Walter Hogan, MD, Principal investigator, Medical College of WisconsinNikhil Shastri, MD, Study director, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01702701
- Sponsor's protocol ID
- MCWEoEMVF
- Status last verified
- Jan 2016
- First submitted
- 4 Oct 2012
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone
- ClinicalTrials.gov ID
- NCT01702701
- Acronym / sponsor ID
- MCWEoEMVF
- Conditions
- Eosinophilic Esophagitis, Dysphagia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- 20 Jul 2017 (actual)
- Study completion
- 20 Jul 2017 (actual)
- First posted
- 8 Oct 2012 (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.
This study will compare response to treatment of Eosinophilic Esophagitis with montelukast vs standard therapy fluticasone. Investigators hypothesize that montelukast is equally effective in treating symptoms and histology of EoE when compared to fluticasone. The study will be conducted at multiple sites with Medical College of Wisconsin as the coordinating site. After identification and recruitment all patients will be randomized (provider blinded) to one of two medications: montelukast 10mg po qday vs fluticasone 440mcg po bid. Patients will also complete a pretreatment, 6 week therapy and 12 week therapy questionaire. They will then undergo a repeat endoscopy to evaluate endoscopic and histologic response.
Detailed description
Eosinophilic esophagitis is an allergic condition of the esophagus with an incidence that is on the rise, and has limited treatment options. Current gold standard of treatment is with topical steroids (swallowed fluticasone). There is preliminary data that oral montelukast may prove to be effective in inducing and maintaining symptomatic along with histologic remission of this disease. Investigators will be comparing the effectiveness of singulair to swallowed fluticasone in inducing and maintaining histologic and symptomatic remission of eosinophilic esophagitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Montelukast | Active comparator | Drug: Montelukastpatients will receive 10 mg po montelukast daily for 12 weeks. |
| Fluticasone | Active comparator | Drug: Fluticasonepatients will receive 440mcg fluticasone po bid for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with a confirmed diagnosis of EoE on biopsy
- with >15 eos per HPF
- ages >18
- Both male and Female.
- Not pregnant
Key exclusion criteria (7 listed)
- pregnancy
- patients receiving ongoing medical therapy for EoE
- patients who underwent dilation in the last 12 weeks with improvement in symptoms
- LA grade B or worse erosive esophagitis.
- age < 18
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 |
|---|---|---|
| MontelukastAlso: Singulairmontelukast 10mg po pill q day for 12 weeks | Drug | Montelukast |
| FluticasoneAlso: Floventfluticasone 440mcg po q bid x 12 weeks | Drug | Fluticasone |
Primary outcome
Improvement in Dysphagia symptom score
Time frame: 3 month
1 secondary outcome
Improvement in esophageal histology counts of eosinophils/hpf
Time frame: 3 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
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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.
Walter Hogan, MD principal investigator
Medical College of Wisconsin
Nikhil Shastri, MD study director
Medical College of Wisconsin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Montelukast and Fluticasone in people with Eosinophilic Esophagitis and Dysphagia, run by Medical College of Wisconsin at 2 sites in United States.
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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 phase mean?
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Dysphagia symptom score (time frame: 3 month). It is what the study was designed to measure, not a finding.
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 28 Aug 2019.