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| 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: | Treatment, Non-Randomized, Single Blind (Subject), Placebo Control, Single Group Assignment, Safety Study |
| 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 |
| 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 |
|---|---|
| Dose escalation: Placebo Comparator |
Drug: Albuterol sulfate
Single dose dry powder by inhalation
|
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 |
Inclusion Criteria
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Respirics Inc. ( Andre van As MD PhD ) |
| Study ID Numbers: | RA1101C |
| Study First Received: | November 29, 2007 |
| Last Updated: | February 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00565591 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
asthma inhaler device albuterol sulfate |
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Respiratory System Agents Neurotransmitter Agents Bronchial Diseases Adrenergic Agents Molecular Mechanisms of Pharmacological Action Albuterol Physiological Effects of Drugs Reproductive Control Agents Adrenergic Agonists Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Tocolytic Agents |
Therapeutic Uses Immune System Diseases Adrenergic beta-Agonists Asthma Anti-Asthmatic Agents Pharmacologic Actions Autonomic Agents Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |