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

Study Overview
=================
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.

Official Title
-----------------
Pilot, Open-Label, Randomized, Repeated Dose, 4-Way Cross-Over, Clinical Pharmacology Study of Beclomethasone Dipropionate (Clenil® Modulite®) 250 µg HFA pMDI Using the Aerochamber Plus™ Spacer Device Versus the Volumatic™ Spacer Device Without or With Charcoal Block in Asthmatic Adults Patients

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* 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


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clenil® Modulite® via AeroChamber Plus™<br>Clenil® Modulite® administered via AeroChamber Plus™ spacer | Drug: Clenil® Modulite® via AeroChamber Plus™<br>* Clenil® Modulite® 250 µg via AeroChamber Plus™ spacer during 14 days<br>|
| Active Comparator: Clenil® Modulite® via Volumatic™<br>Clenil® Modulite® administered via Volumatic™ spacer | Drug: Clenil® Modulite® via Volumatic™ spacer<br>* Clenil® Modulite® 250 µg via Volumatic™ spacer during 14 days<br>|
| Experimental: Clenil® Modulite® via AeroChamber Plus™ plus charcoal block<br>Clenil® Modulite® administered via AeroChamber Plus™ spacer plus charcoal block | Drug: Clenil® Modulite® via AeroChamber Plus™ plus charcoal block<br>* Clenil® Modulite® via AeroChamber Plus™ spacer during 14 days (plus charcoal block at Day 14)<br>|
| Active Comparator: Clenil® Modulite® via Volumatic™ plus charcoal block<br>Clenil® Modulite® administered via Volumatic™ spacer plus charcoal block | Drug: Clenil® Modulite® administered via Volumatic™ spacer plus charcoal block<br>* Clenil® Modulite® administered via Volumatic™ spacer during 14 days (plus charcoal block at day 14)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic exposure to B17MP (active metabolite of BDP) at steady state after repeated dose of Clenil® Modulite® | Plasma AUC0-12h,ss for B17MP | 0-12 hours | 
| Systemic exposure to B17MP (active metabolite of BDP) at steady state after repeated dose of Clenil® Modulite® | Plasma Cmax,ss for B17MP | 0-12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of the pharmacokinetic profile of BDP | AUC and Cmax for BDP | 0-12 hours | 
| Vital signs assessment | Heart rate and Blood pressure assessment | from screening (week -1) to week 8 | 
| haematology and blood chemistry assessment | haematology and blood chemistry assessment | at screening (week - 1) and week 8 | 
| Number of patients with Adverse events | Adverse events | during the 11 weeks of study | 
| FEV1 predose assessment | FEV1 predose assessment as lung function parameter | from screening (week-1) to week 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, PK, Adults