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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Clenil® Modulite® via AeroChamber Plus™

Clenil® Modulite® administered via AeroChamber Plus™ spacer

Group Type EXPERIMENTAL

Clenil® Modulite® via AeroChamber Plus™

Intervention Type DRUG

Clenil® Modulite® 250 µg via AeroChamber Plus™ spacer during 14 days

Clenil® Modulite® via Volumatic™

Clenil® Modulite® administered via Volumatic™ spacer

Group Type ACTIVE_COMPARATOR

Clenil® Modulite® via Volumatic™ spacer

Intervention Type DRUG

Clenil® Modulite® 250 µg via Volumatic™ spacer during 14 days

Clenil® Modulite® via AeroChamber Plus™ plus charcoal block

Clenil® Modulite® administered via AeroChamber Plus™ spacer plus charcoal block

Group Type EXPERIMENTAL

Clenil® Modulite® via AeroChamber Plus™ plus charcoal block

Intervention Type DRUG

Clenil® Modulite® via AeroChamber Plus™ spacer during 14 days (plus charcoal block at Day 14)

Clenil® Modulite® via Volumatic™ plus charcoal block

Clenil® Modulite® administered via Volumatic™ spacer plus charcoal block

Group Type ACTIVE_COMPARATOR

Clenil® Modulite® administered via Volumatic™ spacer plus charcoal block

Intervention Type DRUG

Clenil® Modulite® administered via Volumatic™ spacer during 14 days (plus charcoal block at day 14)

Interventions

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Clenil® Modulite® via AeroChamber Plus™

Clenil® Modulite® 250 µg via AeroChamber Plus™ spacer during 14 days

Intervention Type DRUG

Clenil® Modulite® via Volumatic™ spacer

Clenil® Modulite® 250 µg via Volumatic™ spacer during 14 days

Intervention Type DRUG

Clenil® Modulite® via AeroChamber Plus™ plus charcoal block

Clenil® Modulite® via AeroChamber Plus™ spacer during 14 days (plus charcoal block at Day 14)

Intervention Type DRUG

Clenil® Modulite® administered via Volumatic™ spacer plus charcoal block

Clenil® Modulite® administered via Volumatic™ spacer during 14 days (plus charcoal block at day 14)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No