Clinical trial NCT02584257: Pharmacodynamic Bioequivalence of Metered Dose Inhalers of Albuterol Sulfate in Patients With Stable Mild Asthma
Official title: Comparison of the Pharmacodynamic Profile of Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate Using Bronchoprovocation in Adult Patients With Stable Mild Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mild Persistent Asthma
Lead sponsor: Lupin Ltd.
Sponsor class: INDUSTRY
First posted: 2015-10-22
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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: 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

Eligibility criteria: 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).

Primary outcomes:
measure: Post-dose PC20 Concentration After Receiving Differing Doses of Test, Reference, or Placebo
timeFrame: Post-dose at Visits 2-6 of the study, a total of approximately 4 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: Investigational Research Center Site #110
state: California
city: Mission Viejo
country: United States
facility: Investigational Research Center Site #114
state: California
city: Rolling Hills Estates
country: United States
facility: Investigational Research Center Site #113
state: California
city: San Diego
country: United States
facility: Investigational Research Center Site #112
state: California
city: San Jose
country: United States
facility: Investigational Research Center Site #116
state: California
city: Tallahassee
country: United States
facility: Investigational Research Center Site #106
state: Florida
city: Baltimore
country: United States
facility: Investigational Research Center Site #109
state: Maryland
city: Bethesda
country: United States
facility: Investigational Research Center Site #105
state: Maryland
city: North Dartmouth
country: United States
facility: Investigational Research Center Site #103
state: Massachusetts
city: Saint Louis
country: United States
facility: Investigational Research Center Site #108
state: Missouri
city: Bellevue
country: United States
facility: Investigational Research Center Site #115
state: Nebraska
city: Skillman
country: United States
facility: Investigational Research Center Site #104
state: New Jersey
city: Raleigh
country: United States
facility: Investigational Research Center Site #102
state: North Carolina
city: Cincinnati
country: United States
facility: Investigational Research Center Site #111
state: Ohio
city: Tulsa
country: United States
facility: Investigational Research Center Site #118
state: Oklahoma
city: Medford
country: United States
facility: Investigational Research Center Site #101
state: Oregon
city: Portland
country: United States
facility: Investigational Research Center Site #107
state: Oregon
Study officials:
References: