Eosinphilic Esophagitis
Conditions
Interventions
Trade Name: Nasonex
Pharmaceutical Form: Oromucosal spray
Pharmaceutical form of the placebo: Suspension and solution for spray
Route of administration
Sponsors
NU-sjukvården, Norra Älvsborgs Länssjukhus
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Evaluation of EORTC QLQ-OES18 dysphagia scale, the eating scale and choking item - Evaluation of dysphagia secondary concequences of well being measured in "global health and social functioning dimensions" in SF-36 ;Timepoint(s) of evaluation of this end point: After 8 weeks treatment | — |
Countries
Sweden
Contacts
Public ContactMogens Bove
Mogens Bove
Outcome results
None listed