Subglottic stenosis: Idiopatic, autoimmune, traumatic.
Conditions
Interventions
Trade Name: Kenacort-T
Product Name: Kenacort-T
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: TRIAMCINOLONE ACETONIDE
CAS Number: 76-25-5
Concentration unit: mg/ml milligram(s)/m
Sponsors
Region Örebro Län
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. = 18 - = 70 years old with subglottic stenosis ( ICD diagnose code J38.6, J38.7, J39.8, J95.5, J95.8) that will be treated surgically. 2. Able and willing to leave a written consent. 3. Able and willing to comply with protocol procedures. 4. Have a symtomatic subglottic stenosis 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 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Stenosis caused by a malignant tumor, external preassure on the trachea (eg enlarged thyroid), post radiation effect in the mucous membrande and glotttic or supraglottic involvement. 2. Stenosis that does not respond to endoscopic surgery: deformed cartilage, either in cricoid cartilage and/or trachea. These types of subglottic stenosis are successfully treated with open surgery. 3. Women who are pregnant or nursing when surgery is schedule and during ongoing treatment with steroid injections. In case of uncertainty a pregnancy test is done. Women of childbearing potential not using contraception. 4. Individuals with confirmed or suspected cognitive failure caused by acute or chronical conditions, such as neuro psychiatric illness (eg dementia, retardation etc), patients under intensive care with lowered conciousness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this trial is to investigate whether a series of kenacort injektions after conventional endoscopic treatment for subglottic stenosis prolongs the interval between the treatments.;Secondary Objective: To confirm that a series of steroid injections is safe regardless of the effect on the stenosis.;Primary end point(s): The primary endpoint is the number of months the patient is asymptomatic from their stenosis. The asymptomatic period starts on the day of endoscopic procedure. It ends at 2 years after the endoscopic intervention (dilatation) or when the patient gets a relapse of the stenosis. The patient is encouraged to make a contact with the outpatient's clinic in the ENT department at the University Hospital of Örebro if he/she experiences a deterioration in breathing or voice. A spirometry is done, the patient answers the Dyspnea Index questionnaire and an appointment is made to an ENT-specialist with experience in airway problems who is unaware whether the patient has been treated with saline or triamcinolone acetonide. If the patient is not found to have a relapse of stenosis, he/she continues with the planned controls. Otherwise if a significant relapse is found that is clinically important then the patient is planned to undergo a new endoscopic dilatation, the asymptomatic period as well as the patient's participation in the study ends.;Timepoint(s) of evaluation of this end point: 1 month, 6 months, 1 year and 2 years after the endoscopic dilatation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Occurrence of side effects and adverse events.;Timepoint(s) of evaluation of this end point: 1 month, 6 months, 1 year and 2 years after the endoscopic dilatation | — |
Countries
Sweden
Contacts
Public ContactÖron- näs- och halskliniken
Region Örebro län
Outcome results
None listed