MedTrace Logo

Pharmacokinetic Clinical Study of CHF1535 NEXT DPI® Versus CHF1535 pMDI

NCT01349257 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-07-31

No results posted yet for this study

Summary

The aim of this clinical study is to compare the lung exposure of the contents of the trial drug after administration of the fixed combination between beclomethasone and formoterol delivered via the new Chiesi dry powder inhaler in comparison to the beclomethasone and formoterol delivered via the pressurised metered dose inhaler (pMDI) using a spacer device. To determine lung exposure, the treatments are administered with charcoal block.

Conditions

Interventions

DRUG

BDP/Formoterol

One single day treatment of CHF 1535 100/6 NEXT DPI®: CHF 1535 dry powder for inhalation (fixed combination of beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg per actuation) administered via the NEXT DPI® dry powder inhaler with charcoal block.

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Dave Singh, MD · Medicines Evaluation Unit Ltd, Manchester, United Kingdom

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United Kingdom

Study Locations

More Related Trials

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 NCT01349257 on ClinicalTrials.gov