Patients with allergy-induced, non-infectious diseases of the nasal mucosa (e. g. hay fever) and the sinuses. MedDRA version: 12.1 Level: LLT Classification code 10052106 Term: Rhinosinusitis
Conditions
Interventions
Trade Name: Dexa-SIOZWO mit Dexamethason-21-acetat Nasensalbe
Pharmaceutical Form: Nasal ointment
INN or Proposed INN: Dexamethasone-21-acetate
CAS Number: 1177-87-3
Concentration unit: % percent
Conc
Sponsors
Febena Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female adult patients in the range of 18 to 65 years. Females with childbearing potential can only participate when it is made sure that no pregnancy exists, and a safe hormonal contraception is used. Patients with allergy-induced, non-infectious diseases of the nasal mucosa (e. g. hay fever) and the sinuses. Patients who, after the nature of the trial has been explained to them, have freely given informed consent in writing. Patients have to understand the nature of the study. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Previous or concomitant intake of corticosteroids or NSAIDs (also Aspirin) • Females who are pregnant, or who are breast-feeding. • Patients with fever of 38.5 º C and more. • Patients with known hypersensitivity to related drugs and chemicals. • Patients with a history of a wasting disease/cancer, autoimmune diseases, connective tissue diseases, psoriasis or major allergies (except allergic rhinitis). • Patients with serious anatomical deformations of the nose and sinuses. • Patients who participated in another clinical study within the last 30 days. • Patients with nasal polyposis. • Diseases, which hinder the application of the diagnostic methods or which are expected to overlap with well-being disturbances of interest. • Persons with pacemakers because of possible interactions with electrophysiological measurements. • Depressive patients. • Concomitant treatment with anti-depressive drugs. • Patients being unwilling or unable to provide informed consent, to communicate well with the investigator, or to participate satisfactorily during the entire trial period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary parameter is the baseline adjusted AUC of a combined symptom-medication-score (Total Combined Score) which is generated from the patient-rated Total Symptom Score (TSS) and the Rescue Medication Score (RMS) on days 5 to 9. The TSS (Total Symptom Score) will be evaluated by the sum of symptom scores for: anterior and/or posterior nasal discharge nasal obstruction facial pain/pressure sensation/headache smell dysfunction measured by a 4-point rating scale (from 0 = absent to 3 =severe). The Rescue Medication Score (RMS) records the consumption of rescue medication (Paracetamol-tablets, 500 mg and Xylometazolin nasal spray). ;Secondary Objective: • Change in single symptom scores as nasal discharge, nasal obstruction, facial pain/pressure sensation/headache and smell dysfunction • To evaluate change in health-related quality of life with the Rhino-QoL-Questionnaire • Time till first intake of rescue medication • Consumption of rescue medication • Adverse events • Efficacy and tolerability, rated by the investigator and the patient (measured by verbal rating scales) • Blood pressure and pulse rate;Primary end point(s): The null hypothesis of therapeutic identity (H0) in this trial is that there is no difference between the two treatment groups in terms TCS over the time course of the study compared to baseline. The primary endpoint of this study is the total combined score (TCS), taking into account the baseline-adjusted TSS and the daily RMS. For the TSS and the RMS, the daily values as determined by the patients in their diary are accumulated over the days 5 to 9. The mean daily scores during that period are calculated for both parameters per patient. Then, these 2 means of the scores are combined by the O´Brien-Läuter method: For each score the data are standardized (i. e. by z score transformations), and then added for each patient. | — |
Countries
Germany
Outcome results
None listed