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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00565591
First Posted: November 30, 2007
Last Update Posted: February 15, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Respirics Inc.
  Purpose
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.
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00565591


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

Responsible Party: Andre van As MD PhD, Respirics Inc.
ClinicalTrials.gov Identifier: NCT00565591     History of Changes
Other Study ID Numbers: RA1101C
First Submitted: November 29, 2007
First Posted: November 30, 2007
Last Update Posted: February 15, 2008
Last Verified: February 2008

Keywords provided by Respirics Inc.:
asthma
inhaler device
albuterol sulfate

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
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