deltatrials
Completed PHASE2 INTERVENTIONAL 8-arm NCT01085045

Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PT001, PT003, and PT005 Following Chronic Dosing (7 Days) in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

A Randomized, Double-Blind (Test Products and Placebo), Chronic Dosing (7 Days), Four-Period, Eight-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Two Doses of PT003, Two Doses of PT005 and One Dose of PT001 in Patients With Moderate to Very Severe COPD, Compared With Foradil® Aerolizer® (12 μg, Open-Label) and Spiriva® Handihaler® (18 μg, Open-Label) as Active Controls

Sponsor: Pearl Therapeutics, Inc.

Updated 7 times since 2017 Last updated: Mar 14, 2017 Started: Mar 31, 2010 Primary completion: Nov 30, 2010 Completion: Nov 30, 2010
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01085045, this PHASE2 trial focuses on Chronic Obstructive Pulmonary Disease and remains completed. Sponsored by Pearl Therapeutics, Inc., it has been updated 7 times since 2010, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2017 · 4 months · monthly snapshotCompleted~Jun 2017 – ~Jun 2018 · 12 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

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

    Completed PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE2

  4. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2

  5. Jun 2017 — Jun 2018 [monthly]

    Completed PHASE2

Show 2 earlier versions
  1. Feb 2017 — Jun 2017 [monthly]

    Completed PHASE2

  2. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE2

    First recorded

Mar 2010

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Pearl Therapeutics, Inc.
Data source: Pearl Therapeutics, Inc.

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