Pilot Pharmacokinetic Clenil Study With AeroChamber Plus™ or Volumatic™ Spacer Devices

Launched by CHIESI FARMACEUTICI S.P.A. · Jun 8, 2011

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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.