Back to resultsStudy Mild Intermittent Asthma to Assess the Topical Safety and Tolerability of Albuterol Sulfate Acu-30™ DPI
Primary Purpose
Allergic Asthma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Albuterol sulfate
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Asthma focused on measuring asthma, inhaler device, albuterol sulfate
Eligibility 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
Sites / Locations
- Iowa Clinical Research Corporation
Arms of the Study
Arm 1
Arm Type
Placebo Comparator
Arm Label
Dose escalation
Arm Description
Outcomes
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00565591
Brief Title
Study Mild Intermittent Asthma to Assess the Topical Safety and Tolerability of Albuterol Sulfate Acu-30™ DPI
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Respirics Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Asthma
Keywords
asthma, inhaler device, albuterol sulfate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose escalation
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Albuterol sulfate
Intervention Description
Single dose dry powder by inhalation
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holly Brown, MD
Organizational Affiliation
Private practise
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iowa Clinical Research Corporation
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52240
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study Mild Intermittent Asthma to Assess the Topical Safety and Tolerability of Albuterol Sulfate Acu-30™ DPI
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