| Eligibility |
Inclusion Criteria:
1. Male or female subjects (=12 years of age) of non-childbearing or of childbearing
potential committed to consistent and correct use of an acceptable method of birth
control.
2. Patients diagnosed with asthma, as defined by the National Asthma Education and
Prevention Program (NAEPP), at least 12 weeks months prior to screening (Visit 1).
3. Pre-bronchodilator FEV1 of =45% and =85% of the predicted value (for age =18 years),
or =65% and =90% predicted normal value (for ages 12 to 17 years) during the screening
visit and on the first day of treatment.
4. Currently non-smoking; had not used tobacco products (i.e., cigarettes, cigars, pipe
tobacco) within the past year, and had = 10 pack-years of historical use.
5. =12% and 200 mL reversibility of FEV1 within 30 minutes following 400 mcg salbutamol
(4 puffs) inhalation (pMDI). This may be demonstrated at the Screening Visit or this
test may be repeated on a different day if the patient fails the first attempt anytime
in the period leading up to the day of randomization; If reversibility is not
demonstrated up to the day of randomization then patients may be permitted to enter
the study with historical evidence of reversibility that was performed within 2 years
prior to Screening visit (Visit 1).
6. Patients should be on stable doses of their chronic asthma treatment regimen and
should have well-controlled asthma for at least 4 weeks prior to enrolment.
7. Patients who are able to discontinue their asthma medications (inhaled corticosteroids
and long-acting ß agonists) during the run-in period and for the remainder of the
study, according to investigator's judgement.
8. Patients who are able to replace current short-acting ß agonists (SABAs) with
salbutamol inhaler for use as needed for the duration of the study (subjects should be
able to withhold all inhaled SABAs for at least 6 hours prior to lung function
assessments on study visits).
9. Patients who are able to continue treatment with theophylline or montelukast without a
significant adjustment of dosage, formulation, dosing interval for the duration of the
study, and judged able by the investigator to withhold them for the specified minimum
time intervals prior to each patient visit: 1) montelukast 36 hours 2) short-acting
forms of theophylline 12 hours, 3) twice-a-day controlled-release forms of
theophylline 24 hours, 4) once-a-day controlled-release forms of theophylline 36
hours.
10. Patients who are able to understand the requirements of the clinical trial and to
agree to return for the required follow-up visits.
11. Willing to provide voluntary written informed consent and data protection declaration
(and in the case of a minor their parent/guardian was able to give) before any
clinical trial related procedure is performed.
Exclusion Criteria:
1. Life-threatening asthma, defined as a history of asthma episode(s) requiring
intubation, and/or associated with hypercapnia; respiratory arrest or hypoxic
seizures, asthma related syncopal episode(s), or hospitalizations within the past
year.
2. Significant respiratory disease other than asthma (COPD, interstitial lung disease,
chronic bronchitis, emphysema, etc.).
3. Evidence or history of clinically significant disease or abnormality including
congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery
disease, myocardial infarction, or cardiac dysrhythmia. In addition, historical or
current evidence of significant hematologic, hepatic neurologic, psychiatric, renal,
or other diseases that in the opinion of the investigator, would put the patient at
risk through study participation, or would affect the study analyses if the disease
exacerbated during the study.
4. Hypersensitivity to any sympathomimetic drug (e.g. salbutamol) or any inhaled,
intranasal, or systemic corticosteroid therapy.
5. History of hypersensitivity to lactose.
6. Patients receiving ß-blockers, anti-arrhythmics, polycyclic antidepressants and/or
monoamine oxidase inhibitors within 4 weeks prior to the screening.
7. Asthma exacerbation (i.e. acute or sub-acute worsening in symptoms and lung function
from the patient's usual status) or symptoms or signs of viral or bacterial, upper or
lower respiratory tract infection or sinus or middle ear infection within 4 weeks
prior to the screening visit or during the run-in period.
8. Use of oral or parenteral corticosteroids within 12 weeks prior to Screening visit
(Visit 1)
9. Factors (e.g., infirmity, disability or geographic location) that the investigator
felt would likely limit the patient's compliance with the study protocol or scheduled
clinic visits.
10. Female Subjects who are pregnant or breastfeeding.
11. Women of child-bearing age that are not surgically incapable of pregnancy and are not
willing to use an acceptable method of birth control.
12. Current participation or not yet completed period of at least 30 days since ending
other investigational device or drug trial(s).
13. Unwillingness or inability to comply with the clinical trial procedures;
14. Unwillingness to consent to storage, saving and transmission of pseudonymous medical
data for clinical trial reasons;
15. Who are legally incapacitated;
16. Who are legally detained in an official institute
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