NCT01189396

Escalating and Cumulative-Dose Study of Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety of A006

A Randomized, Double- or Evaluator-blinded, Active- and Placebo-controlled, Cumulative-dose, Dose-escalating, Three-arm, Cross-over Study, in 24 Asthma Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Amphastar Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The main objective is to evaluate the bronchodilatory efficacy, safety and pharmacokinetic profiles of A006 (Albuterol Dry Powder Inhaler (DPI)), in comparison with those of an active control, Proventil-HFA (Albuterol Metered Dose Inhaler (MDI)), and a Placebo DPI in escalating and cumulative-doses up to 1440 mcg, eight (8) times of the proposed clinical dose.

Conditions

• Asthma
• Bronchospasm
• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	A006	Albuterol DPI with 180 mcg Albuterol/inhalation
DRUG	Placebo DPI	Placebo DPI with 0 mcg Albuterol/inhalation
DRUG	Proventil-HFA	Albuterol MDI with 90 mcg Albuterol/inhalation

Timeline

• Start date: 2010-07-01
• Primary completion: 2010-12-01
• Completion: 2011-01-01
• First posted: 2010-08-26
• Last updated: 2017-07-02

Locations

4 sites across 1 country: United States