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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10003553 |
E.1.2 | Term | Asthma |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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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 |
To describe the correlation between increase in ASM content of Na+, K+ pumps and reduction in airway hyperresponsiveness to mannitol after six weeks of daily inhalation of glucocorticoid, in patients with asthma and to describe differences in ASM content of Na+, K+ pumps among healthy subjects and patients with non-eosinophilic asthma (NEA) or eosinophilic asthma (EA) respectively. Primary endpoint:
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Asthma as defined by GINA (www.ginasthma.org) o Eosinophilic asthma: Fractional exhaled nitric oxide (FeNO) > 25 ppb (marker of eosinophilic airway inflammation) o Non-eosinophilic asthma: Fractional exhaled nitric oxide (FeNO) < 25 ppb • An FEV1 value of ≥70% of expected • Airway hyperresponsiveness to mannitol (PD15 ≤ 315 mg) • Not treated with oral or inhaled steroids (past 3 months) • Age 18-64 years
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E.4 | Principal exclusion criteria |
• Smoking (current smokers or a maximum of 10 pack years) • Competing respiratory diseases • Lower respiratory tract infection within the past 4 weeks • Medical history with significant comorbidity (ASA>2) • Pregnant or breastfeeding • Failure to comply with study protocol
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E.5 End points |
E.5.1 | Primary end point(s) |
• Change in airway hyperresponsiveness (mannitol challenge) per change in Na+, K+ pumps content in airway smooth muscle. |
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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) |
Secondary objectives: • Change in Na+, K+ pump content in airway smooth muscle and in skeletal muscle (ρmol ouabain per g wet weight) in patients with NEA vs. (EA). • Change in airway hyperresponsiveness (PD15 to mannitol) in NEA vs. EA. Exploratory objectives: • Change in asthma control score vs in Na+, K+ pumps content in airway smooth muscle • Change in lung function (FEV1) vs in Na+, K+ pumps content in airway smooth muscle • Change in asthma control score in NEA vs. EA • Change in lung function (FEV1) in NEA vs. EA |
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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 | Yes |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
comparative design, with two treatment arms + a group of healthy volunteers not receiving medicine |
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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
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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 | |