A Dose-ranging Study to Evaluate Albuterol and Hydrofluoroalkane in Subjects Ages 12 and Older With Persistent Asthma

Teva Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: ProAir® HFA; Drug: Albuterol Spiromax®; Other: Placebo Inhaler

Study type: Interventional

Funder types: Industry

Identifiers

NCT01058863

ABS-AS-201

Details and patient eligibility

About

This study is examining how well a dry powder inhaler (DPI) of albuterol medication works to help adult and adolescent subjects 12 years of age and older with persistent asthma to improve lung function.

Enrollment: 72 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must provide written informed consent,
• Be between 12 years of age and older,
• Male or Female, females of non-child bearing potential or using reliable contraception
• Asthma for at least 6 months, FEV1 (forced expiratory volume in 1 second) between 50-80% of predicted value, and reversibility greater than or equal to 15% following 180 mcg albuterol
• Stable low dose of Inhaled Corticosteroids
• Non-smoker, 12 months smoking-free and <=10-pack years history
• Otherwise healthy
• Other criteria apply

Exclusion criteria

• Pregnant
• Allergic to albuterol or severe milk protein allergy
• Must not be on another trial for 30days.
• Other criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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72 participants in 5 patient groups, including a placebo group

Albuterol Spiromax® 90 mcg

Experimental group

Description:

A single dose of albuterol 90 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler. Placebo inhalers used to maintain the blind.

Treatment:

Other: Placebo Inhaler

Drug: Albuterol Spiromax®

Albuterol Spiromax® 180 mcg

Experimental group

Description:

A single dose of albuterol 180 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler (2 inhalations). Placebo inhalers used to maintain the blind.

Treatment:

Other: Placebo Inhaler

Drug: Albuterol Spiromax®

ProAir® HFA 90 mcg

Active Comparator group

Description:

A single dose of albuterol 90 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.

Treatment:

Other: Placebo Inhaler

Drug: ProAir® HFA

ProAir® HFA 180 mcg

Active Comparator group

Description:

A single dose of albuterol 180 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler (2 inhalations). Placebo inhalers used to maintain the blind.

Treatment:

Other: Placebo Inhaler

Drug: ProAir® HFA

Placebo Inhaler

Placebo Comparator group

Description:

Placebo delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler, and with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.

Treatment:

Other: Placebo Inhaler