E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic rhinosinusitis with nasal polyposis |
|
E.1.1.1 | Medical condition in easily understood language |
Chronic nasal obstruction |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] |
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 |
Determine the safety of this method of BTA injection in the area of the sphenopalatine ganglion by detecting adverse events |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the effect of the treatment |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Informed and written consent
2. Chronic rhinosinusitis with nasal polyposis defined in EPOS criteria
3. Person from 18 to 70 years old
4. Failed prophylactic treatments with local nasal steroids
|
|
E.4 | Principal exclusion criteria |
1. Heart or lung disease or any kind of systematic or local disease or illness that may significantly increase the risk of complications for the procedure related to injection
2. Psychiatric illness that hinders participation in the study
3. Known pregnancy or breast feeding
4. Inadequate use of contraceptives
5. Abuse of medications, narcotics or alcohol
6. Anomalies which hinder or impede the used method of injection
7. Allergy or any other hypersensitivity reactions against marcain, lidocaine, xylocain or adrenalin
8. Allergy or any other hypersensitivity reactions against botulinum toxin type A, Botox or any of it's constituents or any other related medication
9. Treatment with medication that can interact with botulinum toxin type A
10. Suspicion of allergy to be one of the main causes of polyposis
11. Suspicion of Samters triade |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Adverse events related both to botox and the surgical procedure |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
For the follow-up period of three months |
|
E.5.2 | Secondary end point(s) |
1. changes in symptoms assessed by VAS
2. changes in quality of life evaluated using SNOT-22
3. changes in nasal geometry assessed by acoustic rhinometry
4. changes in nasal airflow measured with PNIF
5. changes in polyps assessed by MRI and CT |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
For the follow-up period of three months |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |