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

Sponsor:	Respirics Inc.
Information provided by:	Respirics Inc.
ClinicalTrials.gov Identifier:	NCT00565591

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 I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) 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:

MedlinePlus related topics: Asthma

Drug Information available for: Albuterol Levalbuterol hydrochloride Albuterol sulfate Levalbuterol tartrate

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:	18 Years to 45 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	Andre van As MD PhD, Respirics Inc.
ClinicalTrials.gov Identifier:	NCT00565591 History of Changes
Other Study ID Numbers:	RA1101C
Study First Received:	November 29, 2007
Last Updated:	February 12, 2008
Health Authority:	United States: Food and Drug Administration

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
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs

Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on February 09, 2012