E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
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 |
The aim of this study is to investigate the effect of supplementation of a single intramuscular dose of 80 mg triamcinolone on the level of MPT-induced dynamic hyperinflation, in adult asthma patients with demonstrated dynamic hyperinflation (Part 1) |
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E.2.2 | Secondary objectives of the trial |
Part 2: To investigate the relationship between MPT-induced dynamic hyperinflation and respiratory symptoms and limitations in daily activities as assessed in different questionnaires Part 3: To investigate the relationship between MPT-induced dynamic hyperinflation and eosinophilic inflammation in peripheral blood. Part 4: To evaluate the agreement between level of dynamic hyperinflation induced by MPT versus CPET. Part 5: To evaluate the difference between levels of MPT-induced dynamic hyperinflation pre vs post bronchodilation in relationship to symptoms, blood eosinophils and triamcinolone-induced changes in dynamic hyperinflation Part 6: To investigate whether specific immunophenotypic characteristics (i.a. expression/activity of type 2 innate lymphoid cells (ILC2)) are associated with (small) airway inflammation and dynamic hyperinflation.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Adults with symptoms compatible with asthma or COPD - Non-smoking, (≤10 packyears) - BMI ≤30 - ICS (≥500 mcg fluticasone equivalent) or daily oral corticosteroids combined with LABA or other controller for at least 6 months. - Stable disease, no exacerbations in last 4 weeks - FEV1/FVC ≤80% of predicted - MPT induced dynamic hyperinflation: Δ IC ≥-10% - CPET induced dynamic hyperinflation: Δ IC ≥-10%
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E.4 | Principal exclusion criteria |
- Concurrent respiratory diseases - Clinically significant cardiovascular disease - Pregnant or breastfeeding women - History of hypertension, diabetes mellitus, menorrhagia, psychiatric diseases, idiopathic thrombocytopenic purpura, ulcus ventriculi, ulcus duodeni, infectious disease, infection after administration of live or live, attenuated vaccines. - Hypersensitivity to any components of triamcinolon acetonide
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E.5 End points |
E.5.1 | Primary end point(s) |
Part 1: The change in MPT-induced dynamic hyperinflation before and 2 weeks after triamcinolone administration. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Part 2: The association between level of MPT-induced dynamic hyperinflation and severity and quality of specific respiratory symptoms as assessed in different respiratory questionnaires (SGRQ, CCQ, ACQ). Part 3: The association between level of MPT-induced dynamic hyperinflation and level of blood eosinophils.. Part 4: The agreement between CPET-induced dynamic hyperinflation and MPT-induced dynamic hyperinflation. Part 5: The difference between levels of MPT-induced dynamic hyperinflation before and after bronchodilation Part 6: The association between the level of specific immunophenotypic parameters (i.a. type 2 innate lymphoid cells) and level of dynamic hyperinflation.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.5 | Efficacy | No |
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) | 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.8.2.4 | Number of treatment arms in the trial | 2 |
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
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The end of the trial is defined as the last patient's 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 |