Pharmacodynamic Bioequivalence of Metered Dose Inhalers of Albuterol Sulfate in Patients With Stable Mild Asthma

Lupin

Status and phase: Completed; Phase 3

Conditions: Mild Persistent Asthma

Treatments: Drug: placebo ProAir HFA; Drug: placebo Lupin albuterol HFA MDI; Other: methacholine chloride; Drug: Lupin albuterol HFA MDI; Drug: ProAir HFA

Study type: Interventional

Funder types: Industry

Identifiers

NCT02584257

AS-MDI-301

Details and patient eligibility

About

The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product, using bronchoprovocation (methacholine challenge testing) in adult patients with stable mild asthma.

Full description

A Multicenter, Double-Blind, Double-Dummy, Placebo-Controlled, 5-Treatment, Randomized, Crossover Study to Demonstrate the Pharmacodynamic Bioequivalence of Test and Reference Metered Dose Inhalers containing Albuterol Sulfate using Bronchoprovocation in Adult Patients with Stable Mild Asthma

Enrollment: 217 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and non-pregnant female subjects (18-65 years of age)
• Stable mild asthmatics based on National Asthma Education and Prevention Program (NAEPP) guidelines.
• Forced Expiratory Volume in 1 second ( FEV1) ≥ 80% of predicted. Airway responsiveness to methacholine demonstrated by a pre-albuterol dose (baseline) PC20 ≤ 8 mg/ml.
• Nonsmokers for at least 1 year prior to the study and a maximum smoking history of five pack-years (the equivalent of one pack per day for five years).
• Written informed consent.

Exclusion criteria

• Conditions which could alter airway reactivity to methacholine (e.g., pneumonia, upper respiratory tract infection, lower respiratory tract, viral bronchitis and/or sinobronchitis) within six weeks preceding the screening visit.
• History of seasonal asthma exacerbations, in which case the patient should be studied outside of the relevant allergen season.
• History of cystic fibrosis, bronchiectasis or other respiratory diseases.
• History of cardiovascular, renal, neurologic, liver or endocrine dysfunction, or chronic condition that could put the safety of the patient at risk during the study or affect the efficacy and safety analyses during the study.
• Treatment in an emergency room, urgent care center, or hospitalization for acute asthmatic symptoms within the past 6 months or need for daily oral corticosteroids within past 3 months.
• Known intolerance or hypersensitivity to any component of the albuterol metered dose inhaler (MDI).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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217 participants in 5 patient groups, including a placebo group

Placebo dose

Placebo Comparator group

Description:

Placebo dose: 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols and one actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols

Treatment:

Other: methacholine chloride

Drug: placebo ProAir HFA

Drug: placebo Lupin albuterol HFA MDI

90 mcg ProAir HFA

Active Comparator group

Description:

90 mcg of ProAir HFA: 1 actuation each from ProAir HFA inhalation aerosol and the placebo ProAir HFA inhalation aerosol and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols

Treatment:

Drug: ProAir HFA

Other: methacholine chloride

Drug: placebo ProAir HFA

Drug: placebo Lupin albuterol HFA MDI

180 mcg ProAir HFA

Active Comparator group

Description:

180 mcg of ProAir HFA: 1 actuation each from 2 different ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols

Treatment:

Drug: ProAir HFA

Other: methacholine chloride

Drug: placebo Lupin albuterol HFA MDI

90 mcg Lupin albuterol HFA MDI

Experimental group

Description:

90 mcg of Lupin albuterol HFA MDI product: 1 actuation each from the Lupin albuterol HFA MDI inhalation aerosol and the placebo Lupin albuterol HFA MDI inhalation aerosol and 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols

Treatment:

Other: methacholine chloride

Drug: placebo ProAir HFA

Drug: placebo Lupin albuterol HFA MDI

Drug: Lupin albuterol HFA MDI

180 mcg Lupin albuterol HFA MDI

Experimental group

Description:

180 mcg of Lupin albuterol HFA MDI: 1 actuation each from 2 different Lupin albuterol HFA MDI inhalation aerosols and 1 actuation each from 2 different placebo ProAir HFA product inhalation aerosols

Treatment:

Other: methacholine chloride

Drug: placebo ProAir HFA

Drug: Lupin albuterol HFA MDI