deltatrials
Recruiting NA INTERVENTIONAL 4-arm NCT04912596

Pharmacodynamic Equivalence of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate in Adult Patients With Stable Mild Asthma

A Randomized, Single-dose, Double-blind, Double-dummy, Placebo and Active Controlled, Crossover Design Study Using Bronchoprovocation to Evaluate the Pharmacodynamic Equivalence of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate in Adult Patients With Stable Mild Asthma

Sponsor: Intech Biopharm Ltd.

Conditions Mild Asthma
Interventions Albuterol Sulfate inhalation Placebo Albuterol Sulfate inhalation aerosol 108 mcg per actuation Methacholine Proair HFA (Albuterol Sulfate) or FDA authorized generic: Albuterol Sulfate HFA (Teva Pharmaceutical USA, Inc.) Inhalation Aerosol 108 mcg per actuation Proair HFA or FDA authorized generic: Albuterol Sulfate HFA Inhalation Placebo
Updated 9 times since 2021 Last updated: Feb 13, 2025 Started: Aug 15, 2022 Primary completion: Jan 31, 2025 Completion: Jun 30, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This NA trial investigates Mild Asthma and is currently actively recruiting participants. Intech Biopharm Ltd. leads this study, which shows 9 recorded versions since 2022 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Sep 2021 – ~Sep 2022 · 12 months · monthly snapshotNot Yet Recruiting~Sep 2022 – ~Dec 2022 · 3 months · monthly snapshot~Dec 2022 – ~Mar 2024 · 15 months · monthly snapshotRecruiting~Mar 2024 – ~Jul 2024 · 4 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Mar 2025 · 6 months · monthly snapshotRecruiting~Mar 2025 – ~Jun 2025 · 3 months · monthly snapshot~Jun 2025 – ~Sep 2025 · 3 months · monthly snapshot~Sep 2025 – present · 12 months · monthly snapshotRecruiting

Change History

9 versions recorded

  1. Sep 2025 — Present [monthly]

    Recruiting NA

  2. Jun 2025 — Sep 2025 [monthly]

    Recruiting NA

  3. Mar 2025 — Jun 2025 [monthly]

    Recruiting NA

  4. Sep 2024 — Mar 2025 [monthly]

    Recruiting NA

  5. Jul 2024 — Sep 2024 [monthly]

    Recruiting NA

▶ Show 4 earlier versions

  1. Mar 2024 — Jul 2024 [monthly]

    Recruiting NA

  2. Dec 2022 — Mar 2024 [monthly]

    Recruiting NA

  3. Sep 2022 — Dec 2022 [monthly]

    Recruiting NA

    Status: Not Yet Recruiting → Recruiting

  4. Sep 2021 — Sep 2022 [monthly]

    Not Yet Recruiting NA

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Intech Biopharm Ltd.
Data source: Intech Biopharm Ltd.

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

Study Locations