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

Study Identifier:
CCD-1008-PR-0049
ClinicalTrials.gov Identifier:
NCT01370031
EudraCT Identifier:
2010-022615-19
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Asthma
Study Drug
  • Drug: Clenil® Modulite® via AeroChamber Plus™
  • Drug: Clenil® Modulite® via Volumatic™ spacer
  • Drug: Clenil® Modulite® via AeroChamber Plus™ plus charcoal block
  • Drug: Clenil® Modulite® administered via Volumatic™ spacer plus charcoal block
Date
Apr 2011 - Jun 2011
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 65 Years
Requirements Information
Inclusion and Exclusion 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.
Healthy Volunteers
No

Protocol Summary

The purpose of this study is to evaluate, at steady-state, the systemic exposure and the lung deposition of B17MP (active metabolite of BDP) as AUC0-12h,ss and Cmax,ss, after inhalation of BDP (Clenil® Modulite®) with the AeroChamber Plus™ spacer device or with the Volumatic™ spacer device without or with charcoal block.

Study Locations

Location
Status
Location
Medicines Evaluation Unit, Wythenshawe Hospital
Manchester, United Kingdom
Status
N/A