Bronchoprovocation Study to Evaluate the Pharmacodynamics of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base

Amneal Pharmaceuticals

Status and phase: Unknown; Phase 3

Conditions: Asthma

Treatments: Drug: 90 mcg Test Product; Drug: Placebo; Drug: 180 mcg Reference Product; Drug: 90 mcg Reference Product

Study type: Interventional

Funder types: Industry

Identifiers

NCT03549897

AI-ABL-001

Details and patient eligibility

About

This randomized, single-dose, double-blind, double-dummy, four-period, four-sequence, four-treatment, placebo and active controlled, comparative, multiple-center, crossover-design bronchoprovocation study has been designed to evaluate the pharmacodynamic equivalence of albuterol sulfate HFA inhalation aerosol, eq 90 mcg base (Amneal Ireland Limited) to PROAIR® HFA (albuterol sulfate) Inhalation Aerosol, eq 90 mcg base (Teva Respiratory, LLC) in patients with stable mild asthma.

Enrollment: 100 estimated 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.
• FEV1 ≥ 80% of predicted.
• Airway responsiveness to methacholine demonstrated by a pre-albuterol-dose (baseline) PC20 ≤ 8 mg/mL.
• Nonsmokers for at least six months 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

• Evidence of upper or lower respiratory tract infection (e.g., pneumonia, bronchitis, sinusitis) within six weeks prior to the study.
• History of seasonal asthma exacerbations, in which case the subject 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, including ECG with evidence of ischemic heart disease.
• Treatment in an emergency room or hospitalization for acute asthmatic symptoms or need for daily oral corticosteroids within past three months.
• Known intolerance or hypersensitivity to any component of the albuterol MDI.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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100 participants in 4 patient groups, including a placebo group

Placebo Product

Placebo Comparator group

Description:

One actuation each from two different placebo Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols

Treatment:

Drug: Placebo

90 mcg Reference Product

Active Comparator group

Description:

One actuation each from the Reference inhalation aerosol and the placebo Reference inhalation aerosol and one actuation each from two different placebo Test inhalation aerosols

Treatment:

Drug: 90 mcg Reference Product

180 mcg Reference Product

Active Comparator group

Description:

One actuation each from two different Reference inhalation aerosol and one actuation each from two different placebo Test inhalation aerosols

Treatment:

Drug: 180 mcg Reference Product

90 mcg Test Product

Experimental group

Description:

One actuation each from the Test inhalation aerosol and the placebo Test inhalation aerosol and one actuation each from two different placebo Reference inhalation aerosols

Treatment:

Drug: 90 mcg Test Product