| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated | |
| 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 | | To determine the proportion of asthma subjects achieving Total control of their asthma in 7 weeks out of the last 8 consecutive weeks of treatment period 2 when given Seretide Diskus 50/250 mcg b.i.d with compliance enhancement training compared to those given medication alone. | |
| E.2.2 | Secondary objectives of the trial | •To determine the proportion of subjects who achieved Total control after treat-ment period 1.
•To determine the time (weeks) to first ’total control week’ within treatment period 2 dependent on absence or presence of compliance enhancement.
•To determine whether there is a difference in the level of quality of life after treatment period 2 dependent on absence or presence of compliance enhancement.
•To determine whether there is a difference in the level of compliance with medi-cation dependent on absence or presence of compliance enhancement.
•To determine improvement in lung function and symptoms.
•To compare asthma severity pre-baseline of the subjects achieving Total control at the end of the study in each treatment group.
| |
| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria | 1) Male or female subjects 18 years of age or above
2) Diagnosed with persistent asthma
3) Treated as an outpatient
4) Treated with up to or equal to 250 mcg fluticasone or up to or equal to 320 mcg budesonide (ex actuator, corresponding to 400 mcg budesonide labelled) b.i.d pre-study (or equivalent for other inhaled corticosteroids) or treated with less than or equal to 50 mcg salmeterol b.i.d pre-study or less than or equal to 9 mcg formoterol (ex actuator, corresponding to 12 mcg labelled formoterol) b.i.d pre-study and/or treated with short acting bronchodilator
5) Non- or ex-smoker (ex-smoker defined as not having smoked during the last year)6) Subjects must give full written, dated, and signed informed consent
7) Female subjects must be post-menopausal, surgically sterile, or using effective contraception (Pearl index > 99).
8) Subject able to comply with the use of the AM2 and the AQLQ in the local language
Inclusion criterion for entry into treatment period 2
9) During treatment period 1, subjects must have failed to achieve the criteria for Total control
| |
| E.4 | Principal exclusion criteria | Exclusion criteria valid for the entire study period
1) Known or suspected Chronic Obstructive Pulmonary Disease (COPD)
2) Pregnant or lactating
3) Participating investigator, employee of an investigator, or family member of any of the aforementioned
4) Smoking history: Pack-years: 10 years or above
5) Have known clinical or laboratory evidence of a serious uncontrolled systemic disease
6) Known hypersensitivity to any substance contained in investigational product or p.r.n medication
7) Participation in a clinical trial with study drug
Exclusion criteria for specifically entry into run-in period
8) Treatment with oral corticosteroid within 2 months prior to screening visit
9) Upper or lower respiratory tract infection (microbiologically verified) within 1 month prior to screening visit
10) Acute asthma exacerbation requiring hospitalisation or emergency room treatment within 3 months prior to the screening visit
11) Participation in a clinical trial with study drug within 1 month prior to screening visit
Exclusion criteria specifically for entry into treatment period 1
12) Changes in asthma medication during the run-in period
13) Treatment with systemic corticosteroids during the run-in period
14) Respiratory tract infection (microbiologically verified) during the run-in period
15) More than one week of Total control prior to baseline visit
Exclusion criteria specifically for entry into treatment period 2
16) Changes in asthma medication during the treatment period 1 as listed in protocol section 8.2.
17) Respiratory infection (microbiologically verified) during treatment period 1
18) Total control achieved during treatment period 1
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| E.5 End points |
| E.5.1 | Primary end point(s) | The proportion (%) of subjects who achieve ‘Total control’ in 7 out of the last 8 consecutive weeks in treatment period 2 with Seretide Diskus 50/250 mcg fixed dosing and compliance enhancement compared with Seretide Diskus 50/250 mcg fixed dosing without compliance enhancement.
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| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | Information not present in EudraCT |
| E.6.2 | Prophylaxis | Information not present in EudraCT |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Information not present in EudraCT |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Information not present in EudraCT |
| E.6.7 | Pharmacodynamic | Information not present in EudraCT |
| E.6.8 | Bioequivalence | Information not present in EudraCT |
| E.6.9 | Dose response | Information not present in EudraCT |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT |
| E.6.11 | Pharmacogenomic | Information not present in EudraCT |
| E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
| E.6.13 | Others | Yes |
| E.6.13.1 | Other scope of the trial description | |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
| E.7.1.1 | First administration to humans | Information not present in EudraCT |
| E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
| E.7.1.3 | Other | Information not present in EudraCT |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
| E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
| E.7.4 | Therapeutic use (Phase IV) | Yes |
| E.8 Design of the trial |
| E.8.1 | Controlled | No |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description | |
| 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 | Yes |
| E.8.2.3.1 | Comparator description | | Compliance enhancement training (asthma education) | |
| 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.8.5 | 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 | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| 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 | |
| E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
| 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 | |
| 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 | 9 |
| E.8.9.1 | In the Member State concerned days | |
| 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 | 9 |
