Study Mild Intermittent Asthma to Assess the Topical Safety and Tolerability of Albuterol Sulfate Acu-30™ DPI

Completed · Phase 1

Conditions studied: Allergic Asthma

In brief

This open label single blind study will determine the safety of albuterol sulfate dry powder in a novel inhaler by observing for the potential occurrence of reflex bronchial constriction after inhalation of increasing doses of the compound.

Key facts

Study ID

NCT00565591

Run by

Respirics Inc.

People needed

12

Starts

2007-11-01

Expected to finish

2008-02-01

Last updated by the study team

2008-02-15

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Mild intermittent asthma (meeting GINA specifications - www.ginasthma.com)
• Medically normal subjects with no significant abnormal findings
• No tobacco (nicotine products) use for at least 2 years before the study starts
• Normal (or abnormal and clinically insignificant) laboratory values at screening (potassium or glucose levels)
• No significant medical or surgical conditions (COPD, cystic fibrosis, severe allergic rhinitis)

You may not qualify if…

• Past or present history of experiencing any allergic reaction to the medications/formulations administered in this study, or in the opinion of the Principal Investigator, suggests an increased potential for an adverse hypersensitivity
• Subject with abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Principal Investigator

Where it is running

• Iowa Clinical Research Corporation — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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