Study Mild Intermittent Asthma to Assess the Topical Safety and Tolerability of Albuterol Sulfate Acu-30™ DPI
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
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Nov 2007
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 29, 2007
CompletedFirst Posted
Study publicly available on registry
November 30, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedFebruary 15, 2008
February 1, 2008
2 months
November 29, 2007
February 12, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 hours
Secondary Outcomes (1)
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.
3 hours
Study Arms (1)
Dose escalation
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Respirics Inc.lead
Study Sites (1)
Iowa Clinical Research Corporation
Iowa City, Iowa, 52240, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Holly Brown, MD
Private practise
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 29, 2007
First Posted
November 30, 2007
Study Start
November 1, 2007
Primary Completion
January 1, 2008
Study Completion
February 1, 2008
Last Updated
February 15, 2008
Record last verified: 2008-02