The objective of this study is to evaluate the pharmacodynamic (PD) bioequivalence (BE) of albuterol inhalers, test formulation: Albuterol Sulfate HFA inhalation aerosol 108 mcg (equal to albuterol base 90 mcg) per actuation and reference formulation: ProAir HFA (albuterol sulfate) or FDA authorized generic: Albuterol Sulfate HFA (Teva Pharmaceutical USA, Inc.) Inhalation Aerosol 108 mcg (equal to albuterol base 90 mcg) per actuation manufactured by two different manufacturers using methacholine bronchoprovocation challenge test in patients with stable mild asthma.
This study will be conducted using the single-dose, randomized, double-blind, double-dummy, four-sequence, four-treatment, and multiple-center study design to evaluate the PD bioequivalence between the test albuterol sulfate (T) inhalation aerosol 108 mcg per actuation (eq. to albuterol base 90 mcg/puff) and the reference albuterol sulfate (R) (ProAir HFA or FDA authorized generic: Albuterol Sulfate HFA \[Teva Pharmaceutical USA, Inc.\]) inhalation aerosol 108 mcg per actuation (equal to albuterol base 90 mcg/puff). The two products will be studied using a crossover design in patients with stable mild asthma by administering a minimum of 3 doses of reference product (0, 90, 180 mcg albuterol) and 2 doses of test product (0, 90 mcg albuterol). The bronchodilation potency of albuterol sulfate are measured by the inhibition effects of methacholine challenge on the bronchodilation, as indicated by increase in the provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
148
equal to albuterol 90 mcg/puff, MDI
equal to albuterol 90 mcg/puff, MDI
Methacholine 100 mg/vial
Dr. Jivraj Mehta Smarak Health Foundation
Ahmedabad, India
NOT_YET_RECRUITINGKLEs Dr Prabhakar Kore Hospital & MRC
Belagāve, India
NOT_YET_RECRUITINGNRS Medical College and Hospital
Kolkata, India
NOT_YET_RECRUITINGMedical College and Hospital
Kolkata, India
NOT_YET_RECRUITINGAakash Healthcare Super Specialty Hospital
New Delhi, India
NOT_YET_RECRUITINGPimpri Chinchwad Municipal Corporation Post Graduate Institute Yashwantrao Chavan Memorial Hospital
Pune, India
NOT_YET_RECRUITINGKothrud Hospital
Pune, India
NOT_YET_RECRUITINGAshirwad Hospital and Research Centre
Ulhasnagar, India
NOT_YET_RECRUITINGKaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
RECRUITINGTamshui Mackay Memorial Hospital
New Taipei City, Taiwan
RECRUITING...and 2 more locations
Post-dose PC20 Concentration
Post-dose PC20, which are the provocative concentrations, respectively, of the methacholine challenge agent required to reduce the forced expiratory volume in one second (FEV1) by 20% following administration of differing concentrations of albuterol (or placebo) by inhalation.
Time frame: 15 minutes post-dose
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