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

NCT ID: NCT00565591

Last Updated: 2008-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2008-02-29

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.

Conditions

Allergic Asthma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Dose escalation

Group Type: PLACEBO_COMPARATOR

Albuterol sulfate

Intervention Type: DRUG

Single dose dry powder by inhalation

Interventions

Albuterol sulfate

Single dose dry powder by inhalation

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Respirics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Respirics Inc.

Principal Investigators

Holly Brown, MD

Role: PRINCIPAL_INVESTIGATOR

Private practise

Locations

Iowa Clinical Research Corporation

Iowa City, Iowa, United States

Countries

United States

Other Identifiers

RA1101C

Identifier Type: -

Identifier Source: org_study_id