Chronic rhinosinusitis
Conditions
Interventions
Trade Name: Sumamed
Product Name: Sumamed
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
prof W.J. Fokkens, academic medical center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects must have a diagnosis of moderate/ severe CRS (as described above in the definition). 2. Age = 18 and = 70 years. 3. Patient must show absence of response to standard treatment regimes like short courses of antimicrobials ( 6 weeks), and nasal douching, in the previous 12 months or FESS (infundibulotomy, ethmoidectomy). 4. Subjects must be > 6 weeks after the last surgical procedure on the nose and sinuses. 5. Sinus CT scan score = 5 at the worst side (partial resp. total opafication) according to the Lund & Mackay scoring system, performed within the previous 6 months before randomization. If subjects have undergone infundibulotomy and the infundibulum is open at the worst site, a score of = 3 is required. 6. Subjects must be willing to give Informed Consent and adhere to visit schedules and medication restrictions. 7. Adequate contraceptive precautions in subjects when child-bearing-potential. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity 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. Subjects who use rifabutin, cyclosporine, digoxin, ergot derivates, lovastatin, warfarin, astemizole, alfentanyl, hexobarbital, and phenytoin or any other drugs suspected to interact with macrolide antibiotics. 5. Subjects administering homeopathica to nose or paranasal sinuses. 6. Severe obstructing, bilateral nasal polyps under middle turbinate. 7. Subjects in whom the infection can be explained by the following reasons: i. Cystic fibrosis ii. Congenital mucociliary problems eg. Primary Ciliary Dyskinesia 8. Known systemic vasculitic and granulomatous disease. 9. AIDS or known to be HIV positive. 10. Very severe septal deviation (septum reaching concha inferior or lateral nasal wall). 11. Craniofacial malformations. 12. Abnormalities requiring other modality of therapy (obstructive polyps, tumors, infection of dental origin). 13. Impaired hepatic function or hepatic disease. 14. Subject of child-bearing-potential not using adequate contraceptive precautions. 15. Subject is pregnant or breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The efficacy will also be evaluated by peak nasal inspiartory flow (PNIF) and nasal swabs.;Primary end point(s): Primary endpoint •Comparison of SNOT-22 score before and after treatment. Secondary endpoints •Comparison of VAS symptom score before and after treatment •Comparison of SF-36 QOL score before and after treatment •Comparison of nasal endoscopic findings before and after treatment ;Main Objective: evaluation of efficacy of prolonged, low-dose macrolide treatment in subjects with chronic rhinosinusitis by 3 quality of life questionnairres and endoscopic findings. | — |
Countries
Finland
Outcome results
None listed