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

This study has been completed.
Information provided by:
Respirics Inc. Identifier:
First received: November 29, 2007
Last updated: February 12, 2008
Last verified: February 2008
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.

Condition Intervention Phase
Allergic Asthma Drug: Albuterol sulfate Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Respirics Inc.:

Primary Outcome 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 Outcome 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 ]

Enrollment: 12
Study Start Date: November 2007
Study Completion Date: February 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Dose escalation Drug: Albuterol sulfate
Single dose dry powder by inhalation

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.

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria

  • Mild intermittent asthma (meeting GINA specifications -
  • 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
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Please refer to this study by its identifier: NCT00565591

United States, Iowa
Iowa Clinical Research Corporation
Iowa City, Iowa, United States, 52240
Sponsors and Collaborators
Respirics Inc.
Principal Investigator: Holly Brown, MD Private practise
  More Information

Responsible Party: Andre van As MD PhD, Respirics Inc. Identifier: NCT00565591     History of Changes
Other Study ID Numbers: RA1101C
Study First Received: November 29, 2007
Last Updated: February 12, 2008

Keywords provided by Respirics Inc.:
inhaler device
albuterol sulfate

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on August 17, 2017