| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated | | Moderate persistent asthma | |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 7.0 | | E.1.2 | Level | LLT | | E.1.2 | Classification code | 10003555 | |
| 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 demonstrate a statistically significant trend across the tacrolimus doses and to determine the efficacy as well as safety and tolerability of four different doses of tacrolimus inhalation aerosol in comparison to placebo and an inhaled corticosteroid in patients with moderate persistent asthma. | |
| E.2.2 | Secondary objectives of the trial | | To obtain information of tacrolimus blood level range (to be measured at day 1, at week 6 and week 12 ). | |
| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria | 1)Male or female patients between 18 and 70 years of age
2)Patients must have a diagnosis of moderate persistent asthma for at least 6 months
3)Steroid naïve patients or patients without steroids for at least 6 weeks prior to study entry must have an FEV1 60 - 80 % of the predicted value
4)Patients must have a reversibility of greater than 15 % and at least a 0.200 liter increase in their FEV1 within 15 to 30 minutes of receiving two puffs of a short acting ß2-agonist at the screening visit
5)Patients must use a short acting ß2-agonist more than two times per day for at least four days per week due to asthma symptoms
6)Female patient of child bearing potential must have a negative serum pregnancy test prior to enrolment and must agree to practice effective birth control during the study.
7)Patient is capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent to participate in the study.
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| E.4 | Principal exclusion criteria | 1)Inhaled, oral or topical corticosteroids within six weeks prior to study entry
2)Respiratory infections within 2 weeks prior to study entry
3)History of tuberculosis
4)Hospitalization (> 24 hours) for an asthma exacerbation within 90 days prior to study entry or has ever been intubated for an asthma exacerbation
5)Moderate to severe liver disease as defined by one or more of the following at Screening:
-Aspartate transaminase (AST) or alanine transaminase (ALT) > 2 times the upper limit of normal range
-Alkaline phosphatase > 3 times the ULN
6)Creatinine > 1.5 times the ULN
7)Hemoglobin < 9.0 mg/dl, WBC < 3000 cells/mm3 or a platelet count < 100.000/mm3
8)Intake of a long-acting ß2-agonist (e.g. salmeterol or formoterol) within 48 hours prior to study entry
9)Patient currently smokes or has discontinued smoking within 6 months prior to the study entry or has a smoking history of ≥ 10 pack years *)
10)Patient has used leukotriene modifiers within 2 weeks prior to study entry
11)Patient has used monoclonal antibodies for the treatment of asthma, methotrexate, gold salts, cyclosporine, tacrolimus (topical or systemic) or azathioprine within 3 months prior to study entry
12)Patient has a decompensated heart failure (NYHA class III and IV)
13)Patient is receiving beta-receptor blocking drugs (including eye-drops)
14)Patient is taking any prohibited concomitant medication (see section 7.3)
15)Patient is known to be HIV positive
16)Patient is pregnant or breast-feeding
17)Female patient capable of childbearing without effective contraception
18)Patient is unlikely to comply with the visits scheduled in the protocol
19)Patient is participating or has participated in another investigational drug trial or is receiving or has received an investigational drug within the last 30 days before entry into this study
20)Patient has a known hypersensitivity to the active substances or the excipients of the study medication
*): Definition of one pack year: Smoking of 20 cigarettes daily for one year or 10 cigarettes daily for two years etc
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| E.5 End points |
| E.5.1 | Primary end point(s) | | The primary efficacy endpoint will be the patient´s treatment success measured as absolute change in patient´s maximum value of FEV1 from baseline to week 12/end of study. | |
| 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 | 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) | 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 | 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) | Yes |
| E.8.2.2 | Placebo | Yes |
| 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 | 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 | | The end of the trial is defined as the last visit of the last patient undergoing the trial. | |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | |
| E.8.9.1 | In the Member State concerned months | 10 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 10 |
