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 is a chronic disease of the airways characterized by attacks of breathlessness, chest tightness, wheezing and coughing. |
Astma is een chronische ziekte van de luchtwegen gekenmerkt door aanvallen van buiten adem zijn, beklemmend gevoel op de borst, piepende ademhaling en hoesten. |
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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 | 14.0 |
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 |
The evaluation of the effect of the combination of formoterol and beclometasone using a DPI device on central and peripheral airway dimensions with Computational Fluid Dynamics (CFD). |
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E.2.2 | Secondary objectives of the trial |
The assessment of the effect of the combination of formoterol and beclometasone using a DPI device on lung function (spirometry, diffusion and resistance), on Asthma Control Test (ACT™) and Asthma Control Questionnaire (ACQ) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Patients with moderate asthma as defined by the current GINA guidelines. Patients can belong to 2 categories:
Group 1 (n=15 to 20, at least 4 current smokers): Patients not well controlled (partially controlled or uncontrolled according to the GINA guidelines) when using medium daily dose of ICS or medium dose ICS + long acting inhaled 2-agonists (LABA) (given for at least 6 weeks as large-particle formulation (non-extrafine).
Group 2 (n=15 to 20, at least 4 current smokers ): Patients well controlled (according to GINA guidelines) when using medium daily dose of ICS or medium daily dose of ICS + LABA given for at least 6 weeks as large-particle formulation (non extrafine).
2. Male or female patients aged ≥18 years
3. Patients with a documented diagnosis of asthma according to the GINA guidelines13
4. Patients with a co-operative attitude and ability to be trained to correctly use Foster NextHaler DPI
5. Written informed consent obtained
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E.4 | Principal exclusion criteria |
1. Patients treated with extrafine ICS either alone or with LABA
2. Pregnant or lactating females or females at risk of pregnancy at screening and not willing to use an appropriate contraception method during the study period
3. Inability to carry out pulmonary function testing
4. History of near fatal asthma
5. Hospitalization due to asthma or symptomatic infection of the airways in the previous 8 weeks
6. Patients with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study
7. Cancer
8. Current alcohol or drug abuse
9. Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients
10. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study
11. Patients who received any investigational new drug within the last 4 weeks prior to the screening visit
12. Patients treated with any non-permitted concomitant medication
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E.5 End points |
E.5.1 | Primary end point(s) |
-Total airway resistance for the segmented airways iRtot
- Peripheral airway resistance(from 4th bifurcation on) for the segmented airways iRperph
- Total airway volume for the segmented airways iVtot
- Peripheral airway volume (from the 4th bifurcation on) for the segmented airways iVperiph
- Relative compliance for each lobe iClobe-rel
- Density of the lung parenchyma given per predifened lung zone Ldens
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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) |
Lung function parameters based on:
-spirometry
-resistance
-diffusion
asthma control based on questionnaires:
-Asthma Control Test (ACT™) and the ACQ-7 items questionnaire |
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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 | 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 | 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 | No |
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.8.3 |
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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Last follow-up visit of last subject |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |