Dose-response of Inhaled Formoterol Using Methacholine Challenge as a Bioassay

NCT00643578 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2011-12-05

Study results available
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Summary

The purpose of this study is to find out whether a difference between two doses of formoterol can be detected by methacholine challenge.

Conditions

Interventions

DRUG

formoterol

a single dose of 24 mcg of formoterol delivered by dry powder inhaler (Twisthaler)

DRUG

formoterol

a single dose of 12 mcg of formoterol delivered by dry powder inhaler (Twisthaler)

DEVICE

Dry Powder Inhaler (Twisthaler)

subjects inhaled deeply and forcefully and held their breath for 10 seconds for each dose

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    collaborator INDUSTRY
  • University of Florida

    lead OTHER

Principal Investigators

  • Leslie Hendeles, PharmD · University of Florida

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • United States

Study Locations

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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 NCT00643578 on ClinicalTrials.gov