This is a pharmacodynamic bioequivalence bronchoprovocation study using single-dose, double-blind, double-dummy, randomized, study consisting of four study treatments (zero dose \[Placebo\], E.Q. 90 mcg Base dose of R inhalation aerosol, E.Q. 180 mcg Base dose of R inhalation aerosol, E.Q. 90 mcg Base dose of T inhalation aerosol) and four Periods (Period 1 to Period 4). Randomization procedure at Period 1 will assign any one study treatment to be administered in each Period in a cross-over manner. By the end of Period 4, a subject who completes dosing in all four Periods would have administered all four treatments in the study.
The efficacy variable, post-dose PC20 obtained during each Period is the provocative concentration of the methacholine challenge agent required to reduce the FEV1 by 20% following administration of differing doses of albuterol (or placebo) by inhalation. The 20% reduction in FEV1 is determined as compared to post-saline FEV1 measured before the Placebo or Albuterol administration.
The pharmacodynamic equivalence will be based on the dose-scale method of analysis of the post-dose PC20 If the 90% confidence interval for the relative bioavailability (F) falls within 67.00% -150.00% then it will be considered that pharmacodynamic equivalence is established.
Male and non-pregnant, non-lactating female subjects aged between 18 to 65 years (both ages inclusive)
Stable mild asthmatics based on National Asthma Education and Prevention Programme (NAEPP) guidelines
Subjects who were diagnosed by physician with mild asthma at least 6 months prior to screening visit date
Pre-bronchodilator forced expiratory volume in one second (FEV1) ≥ 80% of predicted
1.Subjects with FEV1 < 1.5L during methacholine challenge test 2.Evidence of upper or lower respiratory tract infection (e.g., pneumonia, bronchitis, sinusitis) within six weeks prior to the study.
Baseline FEV1 should not be less than 70% of predicted normal value and should be within 88 -112% of qualifying day FEV1 value.
Baseline FEV1 should be ≥ 1.5 L
Baseline FEV1 should meet FEV1 acceptability criteria as mentioned in ATS 2019 standards
Crossover
Albuterol Sulfate 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations
DrugAlbuterol sulfate HFA Inhalation Aerosol (E.Q. 90 mcg of albuterol Base/Inh) (of Macleods Pharmaceuticals Ltd.)
Test Placebo
DrugMatching Placebo of T inhalation aerosol
Reference Placebo
DrugMatching Placebo of R inhalation aerosol
Albuterol Sulfate 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations
DrugAlbuterol sulfate HFA Inhalation Aerosol (E.Q. 90 mcg of albuterol Base/Inh) (distributed by Teva Pharmaceuticals USA, Inc.)
Post-dose PC20 (MG/ML)
* PC20 which is the provocative concentration of the methacholine challenge agent required to reduce the FEV1 by 20% following administration of differing doses of albuterol (or placebo) by inhalation * The 20% reduction in FEV1 is determined as compared to post-saline FEV1 measured before the Placebo or Albuterol administration.
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