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

Cipla

Status and phase: Completed; Phase 3

Conditions: Bronchial Asthma

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02624505

U-SS-M-AS312

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

This study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product in terms of FEV1 measured at different time-points, using bronchoprovocation (methacholine challenge testing) in adult patients with stable mild asthma.

Enrollment: 110 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)
• 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.
• Stable mild asthmatics based on National Asthma Education and Prevention Program (NAEPP) guidelines.
• Nonsmokers for at least 6 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

• Conditions which could alter airway reactivity to methacholine (e.g., pneumonia, upper respiratory tract infection, viral bronchitis and/or sinobronchitis) within six weeks prior to the screening visit.
• History of seasonal asthma exacerbations, in which case the patient should be studied outside of the relevant allergen season.
• History of a clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia.
• History of cystic fibrosis, bronchiectasis or other respiratory diseases other than Asthma
• Historical or current evidence of significant hematologic, hepatic, neurologic, psychiatric, renal, or other diseases
• Known intolerance or hypersensitivity 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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110 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:

Drug : 90 mcg Reference Product 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:

Drug: 180 mcg Reference Product One actuation each from two different Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols

Treatment:

Drug: 180 mcg Reference Product

90 mcg Test Product

Experimental group

Description:

Drug: 90 mcg Test Product 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