A Cumulative Dose Study to Evaluate the Safety and Efficacy of Albuterol in a Dry Powder Inhaler and an HFA MDI (Hydrofluoroalkane Metered Dose Inhaler)

PHASE1CompletedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

January 31, 2010

Primary Completion Date

June 30, 2010

Study Completion Date

June 30, 2010

Conditions
Asthma
Interventions
DRUG

Albuterol dry powder inhaler

Albuterol DPI (dry powder inhaler) delivers 90mcg of albuterol in the excipient lactose with each inhalation. Albuterol will be given on two treatment days (3 to 14 days apart). On each treatment day albuterol will be given as a cumulative dose of 1440mcg as a series of inhalations using both Albuterol in a DPI (dry Powder inhaler) and albuterol in an HFA MDI (hydrofluoroalkane metered dose inhaler), ProAir. One inhaler will contain active drug and one inhaler will contain placebo.

DRUG

Albuterol HFA MDI (hydrofluoroalkane metered dose inhaler)

Albuterol HFA MDI (hydrofluoroalkane metered dose inhaler) delivers 90mcg of albuterol with each inhalation. Albuterol will be given on two treatment days (3to 14 days apart). On each treatment day albuterol will be given as a cumulative dose of 1440mcg as a series of inhalations using both Albuterol DPI (dry powder inhaler) and the comparator inhaler, albuterol HFA MDI (hydrofluoroalkane metered dose inhaler).One inhaler will contain active drug and one inhaler will contain placebo.

Trial Locations (9)

55402

Teva Clinical Study Site, Minneapolis

61761

Teva Clinical Study Site, Normal

68123

Teva Clinical Study Site, Bellevue

80230

Teva Clinical Study Site, Denver

80401

Teva Clinical Study Site, Lakewood

90025

Teva Clinical Study Site, Los Angeles

90048

Teva Clinical Study Site, Los Angeles

97035

Teva Clinical Study Site, Lake Oswego

02747

Teva Clinical Study Site, North Dartmouth

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Parexel

INDUSTRY

lead

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY