chronic rhinitis
Conditions
Interventions
Trade Name: sumamed
Product Name: sumamed
Product Code: l-tb-164/ce-14/1
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral us
Sponsors
Prof V Lund
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients must have a diagnosis of moderate/ severe CRS. 2.Age > 18 and 6 weeks), and nasal douching, in the previous 12 months. 5.Patients must be > 6 weeks after the last surgical procedure on the nose and sinuses. 6.Patients who have not responded to sinus surgery 7.Sinus CT scan changes consistent with CRS, confirming diagnosis (according to recognised scoring system), performed within the previous 6 months before randomization. 8.Subjects must be willing to give informed consent and adhere to visit schedules and medication restrictions. 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: 1. Allergy to macrolides. 2. Systemic or local antibiotic treatment less than 1 month before or during the study. 3. Systemic steroid treatment less than 1 month before or during the study. 4 .Severe obstructing, bilateral nasal polyps. 5. Known cystic fibrosis, systemic vasculitic or granulomatous disease 6. AIDS or known to be HIV positive. 7. Severe septal deviation or craniofacial malformations 8. Patient is pregnant or breast feeding or at risk of pregnancy. 9. Patient has any disorder that compromises ability to give truly informed consent for participation in this study. 10. Patient is currently enrolled in other investigational drug trial(s) or is receiving other investigational agent(s). 11. History of heart disease or ECG abnormalities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: test effects of prolonged macrolide treatment;Secondary Objective: ;Primary end point(s): subjects will be treated for 3 months | — |
Countries
United Kingdom
Outcome results
None listed