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

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.

Timeline

Start

2012-11

Primary completion

2013-04

Completion

2015-10

Drugs

Indications