NCT01256086

Relative Potency of Formoterol Novolizer® 12 µg Compared to Formoterol Aerolizer® 12 µg

Relative Potency of Formoterol Novolizer® 12 µg Compared to Formoterol Aerolizer® 12 µg in Patients With Stable Asthma Using Bronchoprovocation With Methacholine as a Bioassay Randomized, Double-blind, Four-period, Four-sequence Cross-over Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: MEDA Pharma GmbH & Co. KG · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to estimate the relative potency for bronchoprotective effect of formoterol Novolizer 12 µg (test) compared to formoterol Aerolizer 12 µg (reference).

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Formatris 24µg	12µg Formoterol Novolizer#1 + 12µg Formoterol Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
DRUG	Formatris 12µg	12µg Formoterol Novolizer#1 + Placebo Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
DRUG	Foradil P 24µg	Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + 12µg Formoterol Aerolizer #2
DRUG	Foradil P 12µg	Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + Placebo Aerolizer #2

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2010-12-08
• Last updated: 2022-02-11
• Results posted: 2012-09-12

Locations

3 sites across 1 country: United States