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 | 20.0 |
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 demonstrate a reduction in the use of systemic corticosteroids with fevipiprant, compared with placebo. |
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E.2.2 | Secondary objectives of the trial |
1. To evaluate the effect of fevipiprant in terms of difference in daytime and night-time symptom scores using an electronic diary
2. To evaluate the effect of fevipiprant with respect to change from baseline in Asthma Control Questionnaire (ACQ-5) total score
3. To evaluate the effect of fevipiprant with respect to change from baseline in Asthma Related Quality of Life Questionnaire (AQLQ+12) total score
4. To evaluate the effect of fevipiprant in terms of proportion of patients requiring ≥ 7.5mg systemic corticosteroid dose in mg per day continuously for at least 30 days
5. To evaluate the effect of fevipiprant in terms of proportion of patients with no systemic corticosteroid use
6. To evaluate the effect of fevipiprant in terms of time to first prescription of biologic therapy from first dose of study treatment received |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Patients with a diagnosis of asthma for a period of at least 3 months prior to Screening Visit with current asthma severity step 4 or 5 (GINA 2018)
• Currently on treatment with medium or high dose ICS/LABA +/- other controller (i.e.LAMA, LTRA etc. as per GINA) for a minimum of 6 weeks prior to Screening Visit
• At screening, patients with FEV1 of ≤80% of the predicted normal value for the patient, after withholding bronchodilators at Screening Visit and beginning of Run-In Visit .
• An increase of ≥12% and ≥200 ml in FEV1 approximately 10 to 15 minutes after administration of 400 mcg of salbutamol/albuterol prior to randomization (documented historical reversibility is accepted).
• Demonstration of inadequate control of asthma based on an ACQ-5 score ≥1.5 at Screening Visit and Treatment Day 1 Visit
• Documented history of at least 1 asthma exacerbation within 1 year prior to enrolment |
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E.4 | Principal exclusion criteria |
• Asthma exacerbation, within 6 weeks prior to enrolment (screening) that required SCS, hospitalization, or emergency room visit.
• Chronic/ maintenance use of OCS for asthma ( total OCS use days greater than 6 months; continuously or intermittently) within the last year
• Prior use of biologics that has potential to interfere/ affect asthma disease progression, in the previous 6 months from run-in period.
• Any contra-indications of SCS use e.g. diabetes, narrow angle glaucoma, or any other as defined by the treating physician
• Pregnant or nursing (lactating) women
• Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer |
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E.5 End points |
E.5.1 | Primary end point(s) |
Total systemic corticosteroid dose use |
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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) |
- Change from baseline in daytime and night-time symptoms using an electronic diary. The diary consists of 5 questions regarding daytime and nocturnal asthma symptom
- Change from baseline in Asthma Control Questionnaire total score. The ACQ-5 consists of 5 questions on a 7-point scale (0=no impairment, 6=maximum impairment).
- Change from baseline in Asthma Related Quality of Life Questionnaire total score. AQLQ+12 consists of 32 questions each scaled from 1 to 7, where 1 indicates maximal impairment and 7 indicates no impairment
- Proportion of patients requiring ≥ 7.5mg systemic corticosteroid dose in mg per day continuously for at least 30 days
- Proportion of patients with no systemic corticosteroid use
- Time to first prescription of biologic therapy from first dose of study treatment received |
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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 | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 22 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 94 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Belgium |
Bulgaria |
Chile |
Colombia |
Costa Rica |
Czech Republic |
France |
Germany |
Greece |
Hungary |
Peru |
Philippines |
Russian Federation |
Slovakia |
South Africa |
Spain |
Thailand |
Turkey |
United Kingdom |
United States |
Vietnam |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 11 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 10 |