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

Respirics Inc.12 enrolled

Overview

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.

This is a single blind (investigator unblinded), open label, single exposure, non-randomized, single center, outpatient, stepwise, rising dose study in male subjects with mild intermittent asthma to assess topical safety and tolerability of Albuterol Sulfate Acu-30™ DPI, compared with Placebo Acu-30™ DPI. Increasing doses of each drug will be administered in a sequential fashion in 4 steps to 3 different subjects at each step (a total of 12 subjects) with mild intermittent asthma in each step.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Allergic Asthma

Interventions

Albuterol sulfateDRUG

Single dose dry powder by inhalation

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria * 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) Exclusion Criteria: * 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

Locations (1)

Iowa Clinical Research Corporation

Iowa City, Iowa, United States

Outcomes

Primary Outcomes

To assess the safety and tolerability of Albuterol Sulfate Acu-30™ DPI compared with Placebo Acu-30™ DPI in male volunteers with mild intermittent asthma.

Time frame: 3 hours

Secondary Outcomes

To perform an exploratory assessment of the pharmacokinetics (PK) of a single dose of Albuterol Sulfate Acu-30™ in a limited population of male volunteers with mild intermittent asthma.

Time frame: 3 hours

Data from ClinicalTrials.gov

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