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

Allergic Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00565591
• Other study ID #: RA1101C
• Status: Completed
• Phase: Phase 1
• First received: November 29, 2007
• Last updated: February 12, 2008
• Start date: November 2007
• Est. completion date: February 2008

Study information

• Verified date: February 2008
• Source: Respirics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Asthma
• Asthma

Intervention

Drug:
• Albuterol sulfate
Single dose dry powder by inhalation

Locations

Country	Name	City	State
United States	Iowa Clinical Research Corporation	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Respirics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes