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 |
Asthma with recurrent exacerbations |
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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 |
Do the number and duration of asthma exacerbations diminish with the regular use of a bacterial lysate? |
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E.2.2 | Secondary objectives of the trial |
- Do the number and duration of infectious asthma exacerbations diminish with the regular use of a bacterial lysate? - Do the number of clinical and laboratory proven respiratory tract infections (RTI) diminish with the regular use of a bacterial lysate? - Does regular bacterial lysate treatment improves health (pulmonary function, quality of life) - Does medication use and health care utility diminish with regular lysate treatrment? - How do the respiratory and gut microbial colonization dynamics change with the regular use of a bacterial lysate? - How do the airway– and blood immunological markers (T-cell dynamics; cytokine production, ILC2-activity) change with the regular use of a bacterial lysate?
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with proven asthma (airway responsiveness proven by reversibility and histamine PC20 < 8 mg/ml)) who have recurrent airway signs and symptoms despite optimal maintenance medication (medium/high dose inhalation corticosteroid and long-acting β2-agonist; GINA 4).
Specific inclusion criteria - ≥ 2 documented asthma exacerbations in the past winter season (see definition below) - and Asthma Control Questionnaire (ACQ) > 1.5 despite maintenance medication
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E.4 | Principal exclusion criteria |
- Other relevant respiratory conditions, e.g. OSAS, bronchiectasis - Systemic immunological diseases - Current smoking or past smoking > 10 pack years - Other untreated co-morbidity, such as gastro-esophageal reflux disease, ENT problems, psychological disorders - Non-compliance to current medication or inhalation technique - Communication difficulties - Pregnancy or planned pregnancy within 2 years
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E.5 End points |
E.5.1 | Primary end point(s) |
Total asthma exacerbations within 18 months after initiation of intervention |
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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) |
- Number of suspected infectious asthma exacerbations (asthma exacerbation + symptoms of respiratory tract infection + proven new respiratory viral or bacterial pathogen) - Duration of asthma exacerbations - Time to first asthma exacerbation - Number of respiratory tract infections - Change in viral and bacterial colonization - Days free from asthma symptoms - Change in pulmonary function (spirometry parameters) from baseline - Use of oral corticosteroids, β2-agonist treatment and antibiotics - Change in sputum- and blood inflammatory markers (cytokines, chemokines, lymfocyte populations) - Change in airway & gut microbiome - Quality of life/ACQ - Number of outpatient doctor’s visits and hospitalisation - Cost-effectiveness - Number of adverse and serious adverse events
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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 | Yes |
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 | 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.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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 | Yes |
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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |