E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
evaluation of efficacy of prolonged, low-dose macrolide treatment in subjects with chronic rhinosinusitis by 3 quality of life questionnairres and endoscopic findings. |
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E.2.2 | Secondary objectives of the trial |
The efficacy will also be evaluated by peak nasal inspiartory flow (PNIF) and nasal swabs. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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 (<2 weeks), nasal corticosteroids (> 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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We planned to include 120 patients. All patients visit the outpatient clinic 6 times, followed by a interview by telephone 2 weeks after the last visit |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |