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 | 14.1 |
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 determine the efficacy of 3 different doses of AZD5069 compared with placebo on the rate of severe asthma exacerbations over 6 months in adults with uncontrolled persistent asthma, despite treatment with medium to high dose inhaled corticosteroids (≥fluticasone 500 µg or the equivalent daily) and long acting β2 agonists. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the effect of AZD5069 compared with placebo on:
1. the rate and total number of days of asthma-specific hospital admissions/Intensive Care Unit admissions
2. the total number of days on oral corticosteroids due to a worsening of asthma symptoms
3. pulmonary function
4. asthma symptoms, use of rescue medication, and asthma control derived from the eDiary
5. asthma control using the Asthma Control Questionnaire (5-item Version) and the health-related quality of life using the Asthma Quality of Life Questionnaire (Standardised Version)
6.To describe the pharmacokinetics of AZD5069
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Men and women aged 18 years and above. Females of childbearing potential must use a highly effective contraceptive method during the study.
2. Diagnosis of asthma for at least 12 months (GINA 2011)
3. Uncontrolled persistent asthma, despite treatment with medium to high dose ICS and LABA, and with a history of exacerbations during the last year
4. Morning prebronchodilator FEV1 of ≥30% and ≤85% predicted normal at enrolment
5. Daily use of medium or high dose ICS (≥fluticasone 500 µg or the equivalent daily) |
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E.4 | Principal exclusion criteria |
1. Any clinically significant disease or disorder (including any chronic lower respiratory disease other than asthma) that may put the patient at risk or influence study results
2. Patients with recurrent, latent, or chronic infections
3. Active tuberculosis or latent tuberculosis without completion of an appropriate course of treatment or prophylactic treatment
4. Significant lower respiratory tract infection not resolved within 30 days prior to enrolment
5. Current smoker or smoking history of more than 20 pack years |
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E.5 End points |
E.5.1 | Primary end point(s) |
Rate of severe asthma exacerbations during 6 months |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
From start of treatment up to 6 months |
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E.5.2 | Secondary end point(s) |
Rate of asthma-specific hospital admission/Intensive Care Unit admissions during 6 months.
Total number of days of asthma-specific hospital admission/Intensive Care Unit admissions.
Total number of days on oral corticosteroids, due to a worsening of asthma symptoms.
Change from baseline to 2 weeks measurement of pre-bronchodilator FEV1
Change from baseline to 1 month measurement of pre-bronchodilator FEV1
Change from baseline to 2 months measurement of pre-bronchodilator FEV1
Change from baseline to 3 months measurement of pre-bronchodilator FEV1
Change from baseline to 4 months measurement of pre-bronchodilator FEV1
Change from baseline to 6 months measurement of pre-bronchodilator FEV1
Change from baseline to 2 weeks measurement of post-bronchodilator FEV1 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
From start of treatment up to 6 months
From start of treatment up to 6 months
From start of treatment up to 6 months
Baseline (Day 0) and 2 weeks after Day 0
Baseline (Day 0) and 1 month after Day 0
Baseline (Day 0) and 2 months after Day 0
Baseline (Day 0) and 3 months after Day 0
Baseline (Day 0) and 4 months after Day 0
Baseline (Day 0) and 6 months after Day 0
Baseline (Day 0) and 2 weeks after Day 0 |
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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 | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
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 | 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 | 4 |
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 | 19 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 107 |
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 |
Bulgaria |
Canada |
Colombia |
Czech Republic |
Germany |
Hungary |
Mexico |
Poland |
Romania |
Russian Federation |
Slovakia |
South Africa |
Ukraine |
United Kingdom |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |