NCT01252758

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

A Phase II Study to Assess the Efficacy and Safety of a Single Inhaled Dose of Albuterol Sulfate Dry Powder Via the Trivair Deposition System Versus Albuterol Sulfate HFA pMDI in Patients With Intermittent or Persistent Mild Asthma

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Acerus Pharmaceuticals Corporation · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

• Asthma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-04-01
• Completion: 2015-10-01
• First posted: 2010-12-03
• Last updated: 2018-03-13