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

To Compare the Bronchoprotective Effects of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate Using Methacholine Bronchoprovocation Challenge Testing in Stable Mild Asthma Patients.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02624505

Enrollment

110

Registered

2015-12-08

Start date

2015-12-31

Completion date

2016-11-30

Last updated

2019-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchial Asthma

Brief summary

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.

Detailed 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.

Interventions

DRUG90 mcg Reference Product

Drug: 90 mcg Reference Product

DRUG180 mcg Reference Product

Drug: 180 mcg of Reference Product

DRUG90 mcg Test Product

Drug: 90 mcg of Test Product

DRUGPlacebo

Placebo Product

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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).

Design outcomes

Primary

Measure	Time frame
Provocative Concentration of Methacholine Causing 20 % Fall (PC20) in FEV1(Forced Expiratory Volume in 1 second)	1 day

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026