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A Pharmacokinetic/Pharmacodynamic Inhaler Comparison Study in Healthy Volunteers

NCT02403713 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2015-09-28

No results posted yet for this study

Summary

A 2-group healthy volunteer study to compare a breath actuated inhaler (BAI) and a pressurised metered dose inhaler (pMDI) with and without spacer.

Conditions

Interventions

DRUG

Fluticasone/formoterol BAI

Fluticasone/formoterol 125/5 µg breath actuated inhaler (BAI) (250/10 µg total dose)

DRUG

Formoterol

Formoterol

DRUG

Fluticasone/formoterol PMDI without spacer

Fluticasone/Formoteral 125/5µg pMDI without spacer

DRUG

Fluticasone/formoterol PMDI with spacer

Fluticasone/Formoteral 125/5µg pMDI with spacer

DRUG

Fluticasone/formoterol PMDI without spacer low dose

Fluticasone/Formoteral 125/5µg pMDI without spacer, low dose

Sponsors & Collaborators

  • Mundipharma Research Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2014-10-31
Completion
2015-09-30

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 NCT02403713 on ClinicalTrials.gov