| Eligibility |
Inclusion Criteria:
- Must be >=18 years of age, of either gender & of any race.
- Must have had a diagnosis of asthma for at least 6 months, characterized by recurrent
episode of wheezing, breathlessness, chest tightness & coughing.
- Baseline FEV1 must be >=55% and <=85% of predicted at the Screening Visit, when all
restricted medications have been withheld for the specified intervals.
- Must demonstrate evidence of an increase in absolute FEV1 of >=12%, with an absolute
volume increase of at least 200 mL, after reversibility testing at the Screening Visit
or documented in the patients chart reversibility up to 1 year previous to inclusion.
- Must be free of any clinically significant disease (other than asthma), that would
interfere with study evaluations.
- Must be willing to give written informed consent and be able to adhere to dose & visit
schedules.
- Must agree to inform their own usual treating physician about their participation in
the study.
- Non-pregnant women of childbearing potential must be using a medically acceptable,
adequate form of birth control. This includes: 1) hormonal contraceptive as prescribed
by a physician (eg, oral combined, hormonal implant, depot injectable); 2) medically
prescribed IUD; 3) condom in combination with a spermicide; 4) Monogamous relationship
with a male partner who has had a vasectomy or is using a condom plus spermicide
during the study. They must have started this birth control method at least 3 months
prior to Screening (with the exception of condom in combination with a spermicide), &
must agree to continue its use for the duration of the study. Women of childbearing
potential who are not currently sexually active must agree and consent to using a
double-barrier method should they become sexually active during the course of this
study. Women who are surgically sterilized or are at least 1 year postmenopausal are
considered not to be of childbearing potential. However, all female subjects must have
a urine pregnancy test obtained at screening, prior to initiation of treatment, & at
the end of the trial, which must be negative.
- Subjects who did not use the following medication prior to inclusion:
- Beta 2 agonist short-acting (inhaled, oral)(12 Hours)
- Beta 2 agonist long-acting (inhaled)(48 Hours)
- Ipratropium bromide (12 hours)
- Cromolyn sodium, nedocromil (7 days)
- Astemizole (3 months)
- Cetotifeno (3 months)
- Another investigational drug (1 month)
- Theophyline (2 weeks)
- Antihistamines (7 days)
- Anticholinergics (7 days)
- Leukotriene modifiers (2 weeks)
- Oral decongestant long-acting (72 hours)
- Oral decongestant short-acting (24 hours)
- Oral corticosteroids (1 month)
- Injected corticosteroids (3 months)
- Inhaled corticosteroids (24 hours)
- Baseline portable Peak Expiratory Flow at the Screening Visit must be >50% of
predicted. The best value out of 3 must be considered.
Exclusion Criteria:
- Women who are pregnant, breast-feeding, or are pre-menarcheal.
- Have used any investigational drug within the last 30 days or who have ever been
treated with any investigational antibody for asthma or rhinitis.
- Are receiving escalating doses of immunotherapy, oral immunotherapy or short course
(rush) immunotherapy.
- No subject participating in this study may participate in this same study at another
investigational site or in any other investigational study at the same time.
- Must not be randomized into the study more than once.
- Subjects with the following clinical conditions/demography:
- Allergic to corticosteroids or beta-agonists.
- Required hospitalization for asthma control within the previous 3 months.
- Required ventilator support for respiratory failure secondary to their asthma
within the last 5 years.
- Treated in the ER (for a severe asthma exacerbation), or admitted to the hospital
for management of airway obstruction, on 2 or more occasions within the last 6
months.
- Clinical evidence of emphysema, chronic bronchitis, bronchiectasis, or cystic
fibrosis.
- Significant history of renal, hepatic, cardiovascular, metabolic, neurologic,
hematological, respiratory, gastrointestinal, cerebrovascular, or other
significant medical illness or disorder which, in the judgment of the
investigator, could have interfered with the study, or required treatment which
might have interfered with the study.
- Requiring the use of >12 puffs per day of Salbutamol on any 2 consecutive days
between study visits.
- Experienced upper or lower respiratory tract infection within the previous 2
weeks prior to enrollment.
- Clinically relevant abnormal baseline vital sign.
- Clinically significant abnormalities on chest x-ray at the Screening Visit or
within the previous 6 months.
- Evidence of clinically significant oropharyngeal candidiasis.
- Smokers, or ex-smokers who are smoking or have smoked at least 20 years/pack or
subjects who are smoking in the last 6 months.
- Known to be HIV positive.
- Known to be illicit drug abusers.
- HPA axis disturbances.
- Showing any clinical condition considered to be severe.
- Severe airflow obstruction showing to be life-threatening.
- Baseline FEV1 <55% of the predicted normal.
- Uncontrolled hypertension.
- Suspected pneumonia, pneumothorax, pneumomediastinum, pulmonary TB, alpha-1
anti-trypsin deficiency, lung mycosis or pulmonary cystic fibrosis.
- History of thoracic surgery or any previous malignancy of the lung,
- Significant heart disease,
- Receiving beta-adrenergic blocking agents.
- Presenting baseline portable peak expiratory flow at the Screening Visit <=50% of
predicted. The best value out of 3 must be considered.
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