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Phase 3 Completed N=128 Randomized Quadruple-blind Treatment

A Study to Evaluate the Effect of of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base (Sun Pharmaceuticals Industries Limited)

Asthma
Source: ClinicalTrials.gov NCT03528577 ↗
Enrolled (actual)
128
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcomePrimary: Pharmacodynamic Endpoint Post-dose PC20 — 114 mg/mL
◆ Published Evidence
No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

To Evaluate the Pharmacodynamic Equivalence of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg base (Sun Pharmaceuticals Industries Limited) to PROAIR® HFA (albuterol sulfate) Inhalation Aerosol, eq 90 mcg base (Teva Respiratory, LLC) in Subjects With Stable, Mild Asthma

Outcome Measures

OutcomeResultp-value
PRIMARY
Pharmacodynamic Endpoint Post-dose PC20		 114 —

Eligibility Criteria

Inclusion Criteria

  • Men or non-pregnant women 18 to 65 years of age.
  • Signed informed consent form that meets all criteria of current Food and Drug Administration (FDA) regulations.
  • Females of childbearing potential must not be pregnant or lactating (as confirmed by a negative urine pregnancy test
  • Ability to use inhalation aerosol correctly.

Exclusion Criteria

  • Any clinically significant finding on physical exam in the opinion of the Investigator, would compromise subject's safety or data integrity.
  • Employees of the Investigator or research center or their immediate family members.
  • Previous participation in this study.
  • Inability to understand the requirements of the study and the relative information and are unable or not willing to comply with the study protocol.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03528577). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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