Asthma MedDRA version: 7.0 Level: LLT Classification code 10003553
Conditions
Sponsors
Fujisawa GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria in general 1. Male or female asthmatic patients between 18 to 70 years of age, inclusive 2. Patients must have a diagnosis of asthma for at least 12 months 3. Patients pre-treated with ICS for at least 3 months prior to study entry (inhaled daily ICS doses of 800 to 1600 µg budesonide, 1000 to 2000 µg beclomethasone, 500 to 1000 µg fluticasone, 800 to 1600 µg mometasone or equivalent doses of other ICS) and 4. Patients pre-treated with LABAs (formoterol or salmeterol) for at least 3 months prior to study entry or (alternative to inclusion criteria 3. and 4.) 5. Patients pre-treated with ICS and LABA in fixed combination for at least 3 months prior to study entry 6. Patients not well controlled on ICS and LABA, i.e. some asthma symptoms still occurring: - additional usage of an inhaled short-acting beta-2-agonist, or - daily asthma symptoms or - sleep disturbance 7. FEV1 = 50% to 80% of predicted 8. FEV1 reversibility of at least 12% after inhalation of two puffs of a short-acting beta-2-agonist 9. Patients on immunotherapy must have been on a stable dose for one month prior to study entry and remain on that stable dose during the conduct of the study 10. Female patients 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. 11. 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 prior to study entry. Inclusion criteria for randomisation 1. FEV1 differs not more than 15% from the value obtained at the Screening visit and FEV1 is still = 80% of predicted. 2. Patients further not well controlled on combination therapy with ICS and LABA, i.e. some asthma symptoms still occurring: - additional usage of an inhaled short-acting beta-2-agonist (at least two times per day during the last five days preceding the randomisation visit), or - daily asthma symptom score of 2 or more on at least 3 days during the last five days preceding the randomisation visit, or - sleep disturbance score of 1 or more on at least one night during the last five days preceding the randomisation visit Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patient has had a hospitalization (>24 hours) for an asthma exacerbation within six weeks prior to study entry or has ever been intubated for an asthma exacerbation 2. Patient had a respiratory infection within 2 weeks prior to the study 3. Patient has a history of tuberculosis 4. Patient has 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 (ULN) - Alkaline phosphatase > 3 times the ULN 5. Patient has a creatinine > 1.5 times the ULN 6. Patient has a hemoglobin < 9.0 g / dL, WBC count < 3000 cells / mm3 or a platelet count < 100.000 platelets / mm3 7. Patient has an advanced, severe or unstable disease of any type other than moderate to severe asthma (e.g. advanced chronic heart failure NYHA class III or IV, arrythmia, subvalvular aortic stenosis, severe hypertension, aneurysm, ischemic heart disease, AV block III, uncontrolled diabetes mellitus) 8. Patient has a significantly reduced potassium level (hypokalaemia) 9. Patient has thyrotoxicosis 10. Patient has any significant concomitant disease in the opinion of the investigator 11. Patient currently smokes or has discontinued smoking within 6 months prior to study entry or has a smoking history of greater than 10 pack-years 12. Patient has a history of alcohol abuse within the last 5 years 13. Patient has used systemic/oral corticosteroids within six weeks prior to study entry 14. Patient has used leukotriene modifiers within 4 weeks prior to study entry 15. 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 16. Patient is receiving beta-receptor blocking drugs (including eye-drops) 17. Patient is receiving any prohibited concomitant medication 18. Patient is known to be HIV positive 19. Patient had a diagnosis of hematologic or solid malignancy within five years prior to study entry unless patient has received curative therapy and is in complete remission. (Note: Patient with localized skin cancer, i.e. basal cell or squamous cell carcinoma, may participate in the study. Patient who has received adequate treatment for localized cancer may be allowed to participate in the study subject to approval by the Medical Monitor.) 20. Patient is pregnant or breast-feeding mother 21. Patient has a known hypersensitivity to macrolides, the active substances or the excipients of the study medication 22. Patient is unlikely to comply with the visits scheduled in the protocol 23. Patient has been previously enrolled in this study 24. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of inhaled tacrolimus as add-on therapy to an inhaled reference corticosteroid (ICS) in combination with a long-acting beta-2-agonist (LABA) in patients with moderate to severe persistent asthma. ICS+LABA+50 µg tacrolimus BID and ICS+LABA+100 µg tacrolimus BID will be compared (combined and separate) to ICS+LABA+placebo BID. ;Secondary Objective: To investigate efficacy and safety of the two inhaled tacrolimus doses. To obtain tacrolimus blood levels in this asthma population. ;Primary end point(s): The primary endpoint is the absolute change in patient's maximum value of FEV1 from baseline (day 1) to day 84 / end of treatment. | — |
Countries
Czech Republic, Hungary
Outcome results
None listed