E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.0 |
E.1.2 | Level | llt |
E.1.2 | Classification code | 10003555 |
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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 investigate the efficacy of different doses of formoterol fumarate (4.5 µg bid and 9 µg bid) administered by a dry powder inhaler (Ultrahaler™) in comparison to placebo in patients with asthma |
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E.2.2 | Secondary objectives of the trial |
To study the safety and tolerability of formoterol fumarate administered by a dry powder inhaler |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
· written informed consent · outpatient of either sex · good health with the exception of asthma · age 18 to 65 years inclusive · history of persistent bronchial asthma (as defined by GINA 2004) for at least 6 months · pretreatment with rescue medication only during the last 4 weeks prior to B0 · FEV1 ≥ 70 % of predicted when measured at least 6 hours after last use of short-acting beta agonists
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E.4 | Principal exclusion criteria |
Diseases and health status: · clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation · concomitant severe diseases or diseases which are contraindications for the use of LABAs (e.g. diagnosis or history of significant cardiovascular diseases (amongst others coronary insufficiency, aortic stenosis, hypertrophic myopathy, congestive heart failure, prior myocardial infarction, myocardial impairment, cardiac dysrhythmia), insulin-dependent diabetes mellitus, uncontrolled hypertension, hyperthyroidism, thyrotoxicosis, phaeochromocytoma, hypokalaemia, prolonged QTc interval (male > 430 ms, female > 450 ms), family history of Long QTc syndrome, or tachyarrhythmia) · suffering from COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function · current smoking or cessation of smoking within the last 6 months · previous smoking with a smoking history of ≥ 10 cigarette pack-years · more than one in-patient hospitalization or emergency care visit due to asthma exacerbations in the past year before B0.
Medications: · use of inhaled corticosteroids or non-steroidal controller medication within 4 weeks before entry into the baseline period, · use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 3 times during the last 6 months · use of other drugs not allowed as defined in the protocol · washout times of drugs defined in the protocol cannot be adhered to · known or suspected hypersensitivity to formoterol or lactose monohydrate · intolerance to salbutamol or to excipients of the MDI · beginning of immunotherapy during the patient´s participation in the study, or having begun an immunotherapy less than 3 months prior to enrolment, or alternation in regimen of an immunotherapy during the study period
Common criteria: · pregnancy · intention to become pregnant during the course of the study · breast feeding · lack of safe contraception: lack of safe contraception is defined as follows:Female patients of childbearing potential, not using and not will-ing to continue using a medically reliable method of contracep-tion for the entire study duration, such as oral, injectable, or im-plantable contraceptives, or intrauterine contraceptive devices, unless they are surgically sterilized/hysterectomized or post-menopausal > 1 year or who are not using any other method considered sufficiently reliable by the investigator in individual cases.· participation in another study within the 30 days preceding and during the present study · previous enrolment into the current study · enrolment of the investigator, his/her family members, employees, and other dependent persons · known or suspected non-compliance, alcohol or drug abuse · inability to follow the procedures of the study, e.g. due to language problems, psychological disorders · reversal of sleep pattern (e.g. night shift workers). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy variables:
Primary: · time-averaged AUC 0-12h of FEV1 after 1 week of treatment
Secondary: · trough FEV1 · peak FEV1 · proportion of responders as determined from serial FEV1 measurements · time to response as determined from serial FEV1 measurements
Safety variables: · AEs · physical examination · vital signs (BP, HR) · ECG · laboratory work-up |
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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 | Yes |
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 | 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 | No |
E.8.1.6 | Cross over | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
Two different daily doses of Formoterol fumarate (9.0 µg and 18.0 µg) vs Placebo |
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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 | 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
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |