Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Chiesi Farmaceutici S.p.A.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or non-pregnant female patients aged 18-65 years included.
Diagnosis of asthma according to GINA guidelines 2009 made at least 6 months prior to screening.
Patients already treated with a dose of BDP or equivalent up to 2000 µg/day.
FEV1 ≥ 60% of predicted for the patient's normal value at screening and randomisation
You may not be if
Patients treated with oral or parenteral corticosteroids in the previous 8 weeks (12 weeks for parenteral depot corticosteroids) before screening visit.
Exacerbation of asthma symptoms or hospitalization due to asthma exacerbation within the previous one month before screening until randomisation.
Lower respiratory tract infection within one month prior to screening.
Diagnosis of COPD as defined by the current GOLD 2009 (Global Initiative for Chronic Obstructive Lung Disease) Guidelines.
Significant medical history and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality indicative of a significant underlying condition, that may interfere with patient's safety, compliance, or study evaluations, according to the Investigator's opinion.
Treatment with a xanthine derivative (e.g. theophylline) formulation in the 4 weeks prior to screening.
Any enzyme inducing or inhibiting drug (from 8 weeks before screening visit)
Patients who received any investigational new drug within the last 8 weeks before the screening. The patients cannot participate in another clinical study at the same time as the present study.
Blood donation (450 mL or more)or significant blood loss less than 12 weeks before the first intake of study drug.
