drugset / Trial / NCT02403713

A Pharmacokinetic/Pharmacodynamic Inhaler Comparison Study in Healthy Volunteers

NCT02403713

Phase 1 Completed 125 enrolled Mundipharma Research Limited
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2014-08
Primary completion
2014-10
Completion
2015-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluticasone Other / unclassified 125 ug Inhaled
Subject Fluticasone Other / unclassified 250 ug Inhaled
Comparator Formoterol Other / unclassified 5 ug Inhaled
Comparator Formoterol Other / unclassified 10 ug Inhaled
Comparator Formoterol Other / unclassified 12 ug Inhaled

Indications