Asthma
Conditions
Keywords
Asthma, PK, Adults
Brief 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.
Interventions
DRUGClenil® Modulite® via AeroChamber Plus™
Clenil® Modulite® 250 µg via AeroChamber Plus™ spacer during 14 days
DRUGClenil® Modulite® via Volumatic™ spacer
Clenil® Modulite® 250 µg via Volumatic™ spacer during 14 days
DRUGClenil® Modulite® via AeroChamber Plus™ plus charcoal block
Clenil® Modulite® via AeroChamber Plus™ spacer during 14 days (plus charcoal block at Day 14)
DRUGClenil® Modulite® administered via Volumatic™ spacer plus charcoal block
Clenil® Modulite® administered via Volumatic™ spacer during 14 days (plus charcoal block at day 14)
Sponsors
Chiesi Farmaceutici S.p.A.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systemic exposure to B17MP (active metabolite of BDP) at steady state after repeated dose of Clenil® Modulite® | 0-12 hours | Plasma AUC0-12h,ss for B17MP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| evaluation of the pharmacokinetic profile of BDP | 0-12 hours | AUC and Cmax for BDP |
| Vital signs assessment | from screening (week -1) to week 8 | Heart rate and Blood pressure assessment |
| haematology and blood chemistry assessment | at screening (week - 1) and week 8 | haematology and blood chemistry assessment |
| Number of patients with Adverse events | during the 11 weeks of study | Adverse events |
| FEV1 predose assessment | from screening (week-1) to week 8 | FEV1 predose assessment as lung function parameter |
Countries
United Kingdom
Outcome results
None listed