E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Kaikki tutkittavat henkilöt niin lääkeimplantti- kuin nenäsumuteverrokkiryhmässä sairastavat kroonista sinuiittia |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10031748 |
E.1.2 | Term | Other chronic sinusitis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10040755 |
E.1.2 | Term | Sinusitis chronic NOS |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10009137 |
E.1.2 | Term | Chronic sinusitis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008871 |
E.1.2 | Term | Chronic ethmoidal sinusitis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008877 |
E.1.2 | Term | Chronic frontal sinusitis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008998 |
E.1.2 | Term | Chronic maxillary sinusitis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009137 |
E.1.2 | Term | Chronic sinusitis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009138 |
E.1.2 | Term | Chronic sinusitis, ethmoidal |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009139 |
E.1.2 | Term | Chronic sinusitis, other |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009140 |
E.1.2 | Term | Chronic sinusitis, sphenoidal |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009141 |
E.1.2 | Term | Chronic sinusitis, unspecified |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009145 |
E.1.2 | Term | Chronic sphenoidal sinusitis |
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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 |
Prospektiivisen satunnaistetun kliinisen tutkimuksen tarkoituksena on selvittää uuden seulalokeroihin asennettavan lääkeannostelijan tehoa verrattuna samaa kortikosteroidia sisältävään nenäsuihkeeseen. |
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E.2.2 | Secondary objectives of the trial |
Määrittää mahdolliset indikaatiot uudelle hoitomuodolle. Arvioida limakalvojen parantumista ja mahdollisia haittavaikutuksia. Lisäksi haluamme selvittää voidaanko lääkestentin käytöllä vähentää nenän sivuonteloiden Fess-kirurgiaa. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Potilaat sairastavat kroonista rinosinuiittia 2. Lund-Mackay-pisteet seulalokeroissa ≥ 2 3. Nenäpolypoosin aste ≤ 2 4. Potilaiden ikä enemmän kuin 18 ja vähemmän kuin 65 vuotta
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E.4 | Principal exclusion criteria |
1. Potilaiden ikä vähemmän kuin 18 ja enemmän kuin 65 2. Aikaisemmat nenän sivuonteloiden leikkaukset 3. ASA-intoleranssi 4. Diabetes tai jokin muu vakava systeemisairaus 5. Glaukooma 6. Lund-Mackay-pisteet poskionteloissa tai otsaonteloissa >1 7. Etäisyys etummaisen seulalokeron etuseinästä kitaontelon etuseinään <20mm 8. Raskaus tutkimukseen osallistumisen hetkellä
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E.5 End points |
E.5.1 | Primary end point(s) |
Tutkimushypoteesimme on, että seulalokeroihin triamsinoloniasetonidia vapauttava lääkestentti on tehokkaampi kuin triamsinoloniasetonidi-pitoinen nenäsumute hoidettaessa kroonista seulalokerostojen tulehdusta. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
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 | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
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
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |