A 12-week Study to Compare the Efficacy and Safety of Albuterol Spiromax® Versus a Placebo in People 12 Years and Older With Persistent Asthma

Teva Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Albuterol MDPI; Drug: Placebo MDPI

Study type: Interventional

Funder types: Industry

Identifiers

NCT01424813

ABS-AS-301

Details and patient eligibility

About

The study will measure the change in lung function in subjects with asthma after inhaling from either of two inhalers: Albuterol Spiromax® or placebo.

Enrollment: 158 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent/assent
• General good health
• Persistent asthma, with an FEV1 50-80% predicted.
• Ability to perform spirometry in an acceptable manner as per protocol guidelines.
• Ability to perform PEFR with a handheld peak flow meter.
• Demonstration of reversible bronchoconstriction as verified by a 15% or greater increase from baseline FEV1.
• Taking inhaled corticosteroids at a stable dose for at least 4 weeks prior to the Screening Visit.
• Non-smokers.
• Capable of understanding the requirements, risks, and benefits of study participation.
• Other inclusion criteria apply.

Exclusion criteria

• Participation in any investigational drug trial within the 30 days preceding the Screening Visit (SV).
• A known hypersensitivity to albuterol or any of the excipients in the formulations.
• History of severe milk protein allergy.
• History of a respiratory infection or disorder that has not resolved within the 2 weeks preceding the Screening Visit (SV).
• Currently requires treatment with β2-adrenergic receptor antagonists or non-selective β-receptor blocking agents.
• History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation.
• Any asthma exacerbation requiring oral corticosteroids within 3 months of the Screening Visit (SV). A subject must not have had any hospitalization for asthma within 6 months prior to the Screening Visit (SV).
• Historical or current evidence of any clinically significant non-asthmatic acute or chronic condition including.
• Other exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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158 participants in 2 patient groups, including a placebo group

Placebo MDPI

Placebo Comparator group

Description:

Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.

Treatment:

Drug: Placebo MDPI

Albuterol MDPI

Experimental group

Description:

Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.

Treatment:

Drug: Albuterol MDPI