E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pulmonary Fibrosis categorized as UIP or NSIP |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Influence of inhaled Aviptadil on CCL18 serum concentrations in patients with pulmonary fibrosis |
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E.2.2 | Secondary objectives of the trial |
Influence of inhaled Aviptadil on TNF-α concentration in BAL- cell culture supernatant Influence of inhaled Aviptadil on pulmonary compliance. Influence of inhaled Aviptadil on volumes of bodyplethysmography (residual volume, vital capacity, total lung capacity) Influence of inhaled Aviptadil on the quality of life as recorded in appropriate questionnaire forms (SF36, St. George’s Respiratory Questionnaire) 6-minutes walking test
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Diagnosis: clinically active pulmonary fibrosis, based on clinical history, and lung biopsy, consistent with a histologic pattern of UIP or NSIP or a mixture of both. In addtion, the diagnosis IPF/UIP will also be accepted on the basis of the diagnostic criteria of the ATS/ERS consensus statement. Aged above 18 years Written consent Highly effective contraception in female patients of childbearing age Negative pregnancy test
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E.4 | Principal exclusion criteria |
Lack of consent Pregnancy and lactation Presumed non-cooperativeness Malignant diseases in anamnesis Legal incapacity Parallel participation in another clinical trial or participation in any other trial within the previous 30 days Clinical instability in form of general symptoms of fibrosis such as fever (≥ 38oC), fatigue or weakness or hypoxemia under oxygen supplementation (≤ 60 mmHg oxygen, international standards exclude patients with ≤55mmHg). Respiratory insufficiency identified by hypoxemia (PaO2 ≤ 50 mmHg breathing room air) and/or reduction of vital capacity to less or equal of 40% predicted Allergy or hypersensitivity against Aviptadil or any other compound present in the aerosol to be inhaled
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E.5 End points |
E.5.1 | Primary end point(s) |
Decrease of the plasma concentration of CCL-18 in patients with Pulmonary Fibrosis |
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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 | 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 | 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 | Yes |
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
| 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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |