Treatment of patients with eosinophilic esophagitis with mometason furoat aerosol: a randomised, placebo-controled phase II study

Phase 1

• Conditions: Eosinphilic Esophagitis; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2012-005842-39-SE
• Lead Sponsor: -sjukvården, Norra Älvsborgs Länssjukhus

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-05
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

- Age >18 years
- New diagnosed eosinophilic esophagitis according to special criteria
- Women in fertile age if pregnancy is not planned and contraceptive is used during the treatment period, 8 weeks
- Verbal and written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

- Local infection in pharynx or esophagus
- Active or latent tuberculosis in air-route
- Recent trauma or extensive surgery
- Recent extensive infection or other physical stress
- Sign of or suspected dehydration
- Earlier injury, disease or operation on adrenal gland or hypophysis
- earlier or clinical signs of adrenal gland insufficience
- Pharynx- or esophagus surgery or other trauma in esophagus which is not healed
- Planned elective surgery during treatment period
- Pregnancy, ongoing or planned
- Woman in fertile age not using contraceptive during treatment period
- Glaucoma
- Hypersensitivity to any of the ingredients
- General or local steroid treatment during the last 4 months
- Contra indication to steroid treatment (immune-deficiensy or -suppression, gastric ulcer, diabetes
- Medication affecting the mobility of the oesophagus during the treatment period
- Protone pump inhibitor treatment during or up to 2 weeks before treatment period
- Ulcus ventriculi or duodeni where healing is not verified with endoscopy
- Other reason for dysphagia ( cancer, connective tissue disorder, neurological disorder)
- Not able to give consent or completing questionnaires

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the effect of local steroid treatment with Nasonex on swallowing difficulties in patients with eosinophilic esophagitis;Secondary Objective: Evaluate patients quality of life and any side-effects;Primary end point(s): Difference in dysphagia total score on Watson Dysphagia Scale (WDS) between value after treatment and at treatment start;Timepoint(s) of evaluation of this end point: After 8 weeks treatment

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): - Evaluation of EORTC QLQ-OES18 dysphagia scale, the eating scale and choking item<br> - Evaluation of dysphagia secondary concequences of well being measured in global health and social functioning dimensions in SF-36<br> ;Timepoint(s) of evaluation of this end point: After 8 weeks treatment