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 |
The primary objective of this study is to evaluate whether there is a reduction in airway hyper-responsiveness (assessed by PC20 methacholine) attained as a result of using a treatment strategy of aiming for ‘Total control’ compared to a treatment based on maintaining the treatment level at which ‘Well-controlled’ asthma was achieved.
|
|
E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
A subject will be eligible for inclusion in the run-in period only if all of the following inclusion criteria apply: • Male or female subjects > 18 years • Subjects with a documented history of asthma for a period of at least 6 months • Subjects with a PC20 methacholine < 8 mg/ml at Visit 1 • Subjects with a FEV1 % predicted > 70% at Visit 1 • Subjects who have received fluticasone proprionate at a dose of 100 mcg bd to 250 mcg bd or equivalent with or without a long acting beta2-agonist for at least 4 weeks before the start of the run-in period, at a constant dose.
• Subjects who are able to use a Mini Wright peakflow meter • Subjects who are able to use a DISKUS™ inhaler • Subjects who are able to perform reproducible lung function tests at Visit 1 (variation FEV1 < 5% between the two best measurements) • Subjects who are able to comply with therapy • Subjects who are able to understand and complete an electronic DRC. • Subjects able to use VENTOLIN™ on an ‘as required for symptoms’ basis • Subjects who have given written informed consent to participate in the study prior to study participation • A female is eligible to enter and participate in the study if she is: a. of non-child-bearing potential; OR b. of child-bearing potential but has a negative urinary pregnancy test at screening (and when specified in Appendix 1) and agrees to take contraceptive precautions (including abstinence) which are adequate to prevent pregnancy during the study.
A subject will be eligible for inclusion in this study only if all of the following inclusion criteria for the treatment period are met at randomization: • Subjects with a control status of ‘Well-controlled’ asthma excluding subjects with a control status of ‘Total control’ during the last 8 weeks of the run-in period • Subject with a FEV1 % predicted > 70% • Subjects must have recorded data on > 80% of daily entries into their eDRC throughout the run-in period • If subject is of child bearing potential, a negative pregnancy urine test must be performed.
|
|
E.4 | Principal exclusion criteria |
A subject will not be eligible for inclusion in this study if any of the following criteria are met: • Subjects who have been hospitalised for their asthma within 4 weeks of Visit 1 • Subjects who had an acute upper respiratory tract infection within 4 weeks or a lower respiratory tract infection within 4 weeks prior to Visit 1 • Subjects who received oral, parental or depot corticosteroids within 4 weeks prior to Visit 1 • Subjects who have a known respiratory disorder other than asthma and/or systemic/thoracic abnormalities which influence normal lung function • Subjects who have received any investigational drugs within 4 weeks of Visit 1 • Subjects with a known or suspected hypersensitivity to inhaled steroids, β2-agonists or lactose • Subjects who use any medication that significantly inhibits the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketoconazole • Subjects who concurrently participate in another clinical study • Subjects who have previously been randomised in this study • Smoking history: Subjects who have more than 5 pack years • Subjects who currently smoke
Subjects will be excluded from participating in the treatment period of the study if the following, in addition to the exclusion criteria for entry into the run-period, occurred during the run-in period: • Any change in their run-in asthma medication • Non-compliance with the completion of the eDRC
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of this study is: Mean change in PC20 methacholine (as a measure of airway hyper-responsiveness) following 24 weeks of treatment
|
|
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 | Information not present in EudraCT |
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 | 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) | 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 | 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) | Yes |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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 | 4 |
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 | 4 |