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A Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects With Asthma

NCT01656811 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2012-08-03

No results posted yet for this study

Summary

Multicenter, randomized, double-blind, placebo- and active-controlled, Phase II, parallel-group study of up to four weeks in duration. The study consisted of a screening visit followed by a one-week single blind placebo period. At next visit, each subject was randomized to one of four treatment groups: 90 mcg levalbuterol, 180 mcg levalbuterol, 180 mcg racemic albuterol, or placebo. All study medication was administered as 2 actuations 4 times a day for 21 days.

Conditions

Interventions

DRUG

levalbuterol 90 mcg

90 mcg levalbuterol delivered via MDI 2 actuations of 45 mcg QID

DRUG

levalbuterol 180 mcg

180 mcg levalbuterol delivered via MDI 2 actuations of 90 mcg QID

DRUG

racemic albuterol 180 mcg

180 mcg racemic albuterol delivered via MDI 2 actuations of 90 mcg QID

DRUG

Placebo

Placebo 2 actuations QID

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Principal Investigators

  • Xopenex Medical Director, MD · Sumitomo Pharma America, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2001-10-31
Primary Completion
2002-07-31
Completion
2002-07-31

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Drugs
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 NCT01656811 on ClinicalTrials.gov