CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 44 enrolled
Drug / intervention
Formatris 24µg +3 moredrug
Likely dose
Formatris 24µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01256086
NCT01256086Phase 2Completed
CompareCT.gov

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

MEDA Pharma GmbH & Co. KG·interventional·Posted Dec 8, 2010·Updated Feb 11, 2022

In Brief

A Phase 2 clinical trial evaluating Formatris 24µg, Formatris 12µg, and 2 other interventions for Asthma. Completed, enrolled 44 participants across 3 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
CollaboratorsClinResearch, GmbH, Trio Clinical Research, LLC, Raleigh, USA, NuCara Pharmacy, Waterloo, USA, Prof. Hochhaus, Gainesville, USA

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 8, 2010
Enrollment StartDec 1, 2010
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 15.6 years ago

Interventions

Formatris 24µgdrug

12µg Formoterol Novolizer#1 + 12µg Formoterol Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2

Formatris 12µgdrug

12µg Formoterol Novolizer#1 + Placebo Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2

Foradil P 24µgdrug

Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + 12µg Formoterol Aerolizer #2

Foradil P 12µgdrug

Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + Placebo Aerolizer #2