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Dose-Response of Salmeterol in Children

NCT01907334 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2014-10-07

Study results available
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Summary

To examine whether a breathing test (methacholine challenge using impulse oscillometry) can be used to tell the difference between two different doses of an inhaled drug, salmeterol, delivered by Advair in children with asthma

Conditions

Interventions

DRUG

Advair Diskus100/50 µg

Advair Diskus 100/50 µg

DRUG

Flovent Diskus 100 µg

Flovent Diskus 100 µg

DRUG

Methacholine Chloride

Methacholine Chloride in quadrupling concentrations from 0.25 to 64 mg/mL will be given based upon subject's baseline response.

DRUG

Albuterol

Albuterol will be administered at the end of each methacholine challenge.

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
SINGLE
Model
CROSSOVER

Eligibility

Min Age
4 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-05-31
Completion
2014-07-31

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 NCT01907334 on ClinicalTrials.gov