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

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.

Full Title of Study: “A Stepwise, Rising Dose Study of Male Subjects With Mild Intermittent Asthma to Assess the Topical Safety and Tolerability of Albuterol Sulfate Acu-30™ DPI Compared With Placebo Acu-30™ DPI”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: January 2008

Detailed Description

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.

Interventions

  • Drug: Albuterol sulfate
    • Single dose dry powder by inhalation

Arms, Groups and Cohorts

  • Placebo Comparator: Dose escalation

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Respirics Inc.
  • Provider of Information About this Clinical Study
    • Andre van As MD PhD, Respirics Inc.
  • Overall Official(s)
    • Holly Brown, MD, Principal Investigator, Private practise

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