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Dose Finding Study of Albuterol Sulfate in Patients With Intermittent or Persistent Mild Asthma

NCT01252758 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2018-03-13

No results posted yet for this study

Summary

The drug product albuterol sulfate DPI, TBS-7, is a single dose inhalation product of albuterol sulfate containing 240 ug albuterol sulphate (200 ug of albuterol) and inhalation grade lactose in a new dry powder delivery system called the Trivair deposition system.

Three different doses of albuterol sulfate DPI, TBS-7, will be administered in this dose ranging clinical trial: an optimal dose, 80% of the optimal dose and 50% of the optimal dose and will be compared with placebo and an active comparator.

Conditions

Interventions

DRUG

albuterol sufate DPI (TBS-7) dose 1

DRUG

albuterol sufate DPI (TBS-7) dose 2

DRUG

albuterol sufate DPI (TBS-7) dose 3

OTHER

Placebo

DRUG

Albuterol

DRUG

Albuterol

Sponsors & Collaborators

  • Acerus Pharmaceuticals Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2013-04-30
Completion
2015-10-31

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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 NCT01252758 on ClinicalTrials.gov