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

NCT01256086 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2022-02-11

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • ClinResearch, GmbH

    collaborator OTHER

  • Trio Clinical Research, LLC, Raleigh, USA

    collaborator UNKNOWN

  • NuCara Pharmacy, Waterloo, USA

    collaborator UNKNOWN

  • Prof. Hochhaus, Gainesville, USA

    collaborator UNKNOWN

  • MEDA Pharma GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Leslie Hendeles, Professor · University of Florida, Gainesville, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States

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 NCT01256086 on ClinicalTrials.gov