Efficacy of Inhaled Albuterol Spiromax® in Subjects With Persistent Asthma With Steady State Pharmacokinetics

Teva Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Placebo MDPI; Drug: Albuterol MDPI

Study type: Interventional

Funder types: Industry

Identifiers

NCT01747629

ABS-AS-304

Details and patient eligibility

About

The primary objective of this study is to evaluate the efficacy of Albuterol Spiromax® versus placebo in subjects with persistent asthma.

Enrollment: 160 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent/assent
• At least 12 years of age at screening
• General good health
• Persistent asthma for ≥3 months, with an FEV1 50-80% predicted and ≥15% reversibility
• Taking inhaled corticosteroids at a stable dose (≤ equivalent of 500mcg of fluticasone propionate/day) for at least 4 weeks prior to the Screening Visit.
• Ability to perform spirometry in an acceptable manner as per protocol guidelines
• Other inclusion criteria apply

Exclusion criteria

• A known hypersensitivity to albuterol or any of the excipients in the formulations.
• History of a respiratory infection or disorder that has not resolved within 1 week preceding the Screening Visit (SV).
• 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 SV. A subject must not have had any hospitalization for asthma within 6 months prior to the SV.
• Hospitalization due to asthma exacerbation 2 or more times in the past year
• Initiation of immunotherapy or dose escalation during the study period
• Other exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 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