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

Completed · Phase 3 · Has a placebo group

Conditions studied: Mild Persistent Asthma

In brief

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.

Key facts

Study ID

NCT02584257

Run by

Lupin, Inc.

People needed

217

Starts

2016-04-01

Expected to finish

2016-09-01

Last updated by the study team

2020-12-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Investigational Research Center Site #110 — Huntington Beach, California, United States
• Investigational Research Center Site #114 — Mission Viejo, California, United States
• Investigational Research Center Site #113 — Rolling Hills Estates, California, United States
• Investigational Research Center Site #112 — San Diego, California, United States
• Investigational Research Center Site #116 — San Jose, California, United States
• Investigational Research Center Site #106 — Tallahassee, Florida, United States
• Investigational Research Center Site #109 — Baltimore, Maryland, United States
• Investigational Research Center Site #105 — Bethesda, Maryland, United States
• Investigational Research Center Site #103 — North Dartmouth, Massachusetts, United States
• Investigational Research Center Site #108 — St Louis, Missouri, United States
• Investigational Research Center Site #115 — Bellevue, Nebraska, United States
• Investigational Research Center Site #104 — Skillman, New Jersey, United States
• Investigational Research Center Site #102 — Raleigh, North Carolina, United States
• Investigational Research Center Site #111 — Cincinnati, Ohio, United States
• Investigational Research Center Site #118 — Tulsa, Oklahoma, United States
• Investigational Research Center Site #101 — Medford, Oregon, United States
• Investigational Research Center Site #107 — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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