A RANDOMISED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TACROLIMUS MDI AS ADD-ON THERAPY TO ICS AND LABA IN MODERATE TO SEVERE PERSISTENT ASTHMATIC PATIENTS - Tacrolimus MDI, add-on to ICS and LABA, moderate to severe persistent asthma
- Conditions
- AsthmaMedDRA version: 7.0Level: LLTClassification code 10003553
- Registration Number
- EUCTR2004-002078-45-CZ
- Lead Sponsor
- Fujisawa GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method