Pharmacodynamic Equivalence of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate in Adult Patients With Stable Mild Asthma
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…
Conditions studied
Mild Asthma
About this study
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.
Interventions
- Drug: Albuterol Sulfate inhalation aerosol 108 mcg per actuation — equal to albuterol 90 mcg/puff, MDI
- Drug: Proair HFA (Albuterol Sulfate) or FDA authorized generic: Albuterol Sulfate HFA (Teva Pharmaceutical USA, Inc.) Inhalation Aerosol 108 mcg per actuation — equal to albuterol 90 mcg/puff, MDI
- Other: Proair HFA or FDA authorized generic: Albuterol Sulfate HFA Inhalation Placebo — MDI
- Other: Albuterol Sulfate inhalation Placebo — MDI
- Other: Methacholine — Methacholine 100 mg/vial
Primary outcomes
- Post-dose PC20 Concentration (15 minutes post-dose)
Eligibility information
Study locations
- Dr. Jivraj Mehta Smarak Health Foundation, Ahmedabad, 38007 India
- KLEs Dr Prabhakar Kore Hospital & MRC, Belagāve, 590010 India
- NRS Medical College and Hospital, Kolkata, 700014 India
- Medical College and Hospital, Kolkata, 700073 India
- Aakash Healthcare Super Specialty Hospital, New Delhi, 110075 India
- Pimpri Chinchwad Municipal Corporation Post Graduate Institute Yashwantrao Chavan Memorial Hospital, Pune, 411018 India
- Kothrud Hospital, Pune, 411038 India
- Ashirwad Hospital and Research Centre, Ulhasnagar, 421004 India
- Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City, 807 Taiwan
- Tamshui Mackay Memorial Hospital, New Taipei City, 251 Taiwan
Showing 10 of 12 reported sites. See the official listing for all locations.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.