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

NCT01370031 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-03-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Clenil® Modulite® via AeroChamber Plus™

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

DRUG

Clenil® Modulite® via Volumatic™ spacer

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

DRUG

Clenil® Modulite® via AeroChamber Plus™ plus charcoal block

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

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)

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Dave Singh, MD · Medicine Evaluation Unit, Manchester, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01370031 on ClinicalTrials.gov