deltatrials
Unknown PHASE3 INTERVENTIONAL 4-arm NCT03549897

Bronchoprovocation Study to Evaluate the Pharmacodynamics of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base

A Randomized, Single-Dose, Double-Blind, Double-Dummy, Four-Period, Four-Sequence, Four-Treatment, Placebo and Active Controlled, Comparative, Multiple-Center, Crossover-Design, Bronchoprovocation Study to Evaluate the Pharmacodynamic Equivalence of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base (Amneal Ireland Limited) to PROAIR® HFA (Albuterol Sulfate) Inhalation Aerosol, eq 90 mcg Base (Teva Respiratory, LLC) in Patients With Stable, Mild Asthma

Sponsor: Amneal Ireland Limited

Conditions Asthma
Updated 5 times since 2018 Last updated: Jun 13, 2018 Started: Mar 16, 2018 Primary completion: Aug 31, 2018 Completion: Sep 30, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Asthma and is currently ongoing. Amneal Ireland Limited leads this study, which shows 5 recorded versions since 2018 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jul 2018 – ~Jul 2020 · 24 months · monthly snapshotRecruiting~Jul 2020 – ~Jan 2021 · 6 months · monthly snapshotUnknown Status~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – present · 22 months · monthly snapshotUnknown

Change History

5 versions recorded
  1. Sep 2024 — Present [monthly]

    Unknown PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Unknown PHASE3

    Status: Unknown StatusUnknown

  3. Jan 2021 — Jul 2024 [monthly]

    Unknown Status PHASE3

  4. Jul 2020 — Jan 2021 [monthly]

    Unknown Status PHASE3

    Status: RecruitingUnknown Status

  5. Jul 2018 — Jul 2020 [monthly]

    Recruiting PHASE3

    First recorded

Mar 2018

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Amneal Ireland Limited
Data source: Amneal Ireland Limited

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations