Treatment of Eosinophilic Esophagitis With Mometason Furoat Aerosol: a Randomised, Placebo-controled Phase II Study for Evaluation of Treatment Effect on Group Level Including Symtom Questionnaires
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Watson Dysphagia Scale Score (WDS)
研究概览
简要总结
Background:
Eosinophilic esophagitis ( EoE ) is a disease entity which has been properly recognized only within the past two decades.(1) A prevalence of nearly 1% means that almost 20,000 people in the Region of Western Sweden may be affected.(2 ) The main symptom is swallowing difficulty and food may be stuck, which typically require acute hospital care with operational action under general anesthesia.( 3,4 ) The standard treatment today is local treatment with steroids by mouth several times a day for a few weeks.( 5 ) In adults and large teenagers, there is only one randomized study which has shown that budesonide has a significant effect exaggerating that of placebo. However, the main end-point in this study was the degree of tissue inflammation.(6) In a separate study using validated questionnaires , we have shown that patients with EoE have distinct organ-specific symptoms and a lowered quality of life . These symptoms nearly disappeared, after treatment with mometasone furoate. However, as that study was not randomized or placebo controlled no causal conclusions could be drawn regarding the treatment effect, but the method of validated questionnaires proved sensitive to changes in symptomatology.(7) Purpose The primary purpose of this study is to evaluate the effect of local steroid treatment with mometasone furoate on swallowing problems in patients with EoE . Secondarily, to evaluate the effect on patient quality of life and the presence of side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years
- •Newly diagnosed cases with diagnostic criteria for EoE (ie at least 15 eosinophils per high power field (Magnification 10 times 40 = x400) in any field of view in any esophageal biopsy and concurrent symptoms of esophageal dysfunction mainly dysphagia.
- •Women of childbearing age may participate provided that the pregnancy is not planned , and that contraceptive use during therapy. The investigator will arrange a free pregnancy test must be performed within 1 week before treatment and be negative.
- •Participation requires oral and written informed and signed consent form (see patient information and consent forms).
排除标准
- •Local infection of the pharynx or esophagus , such as fungal, bacterial or viral infection
- •Active or latent tuberculosis in respiratory tract
- •Recent history of major trauma or major surgery
- •Recent significant infection or other physical stress
- •Signs or suspicion of dehydration
- •History of injury, illness or surgery in the adrenals or pituitary
- •Pharynx or esophagussurgery or other trauma in the esophagus (incl. foreign body with a sharp object ) where healing has not taken place. (in case of doubt to be assessed by esophago - gastroscopy.
- •Planned elective surgery during treatment
- •Pregnancy, ongoing or planned
- •Women of childbearing potential not using preventives during the study period
- •Hypersensitivity to any component in the treatments
- •Systemic or local steroid treatment last 4 months
- •Contraindication to steroid therapy ( immune deficiency or suppression , stomach ulcers, diabetes)
- •Medications that affect oesophageal motility (cisapride, erythromycin ) during the treatment period .
- •PPIs during or up to 2 weeks before the treatment period
- •Other cause of dysphagia (cancer, connective tissue disease , neurological disease )
- •Volunteer who can not consent to the study or complete a questionnaire
研究组 & 干预措施
Mometasone furoat
Mometasone furoate monohydrate. 4 spray doses à 50 micrograms by mouth to be swallowed 4 times daily after meals (9) with no eating or drinking allowed 30 minutes after intake. Duration of treatment is 8 weeks.
干预措施: Mometasone furoate (Drug)
Placebo spray
Placebo. 4 spray doses à 50 micrograms by mouth to be swallowed 4 times daily after meals (9) with no eating or drinking allowed 30 minutes after intake. Duration of treatment is 8 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Watson Dysphagia Scale Score (WDS)
时间窗: Two months
Difference in WDS score during treatment in active as compared to placebo group.
次要结局
- The EORTC QLQ-OES18 dysphagia scale, the eating scale and choking item(Two months)
研究者
Mogens Bove
Associate Professor
Vastra Gotaland Region