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COMPLETED Phase 2

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)

NCT01085045 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to evaluate, after 1 week of dosing, the efficacy and safety of PT003 compared with its individual components (PT001 and PT005), placebo and two active comparators to demonstrate superiority of the combination to its components, and to assess the relative contribution of the components compared with placebo, in patients with moderate to very severe COPD.

Interventions

  • DRUG PT003 MDI
  • DRUG PT005 MDI
  • DRUG Placebo MDI
  • DRUG Tiotropium bromide 18 μg (Spiriva Handihaler®)
  • DRUG Formoterol Fumarate 12 μg (Foradil® Aerolizer®)

Study Locations (16)

New South Wales

  • Austrials — Caringbah
  • Woolcock — Glebe
  • Austrials — Hornsby

Queensland

  • Austrials — Auchenflower
  • Q-Pharm — Herston

Auckland

  • Greenlane Clinical Centre — Epsom
  • NZ Respiratory & Sleep Institute — Greenlane East

Florida

  • Clinical Research of West Florida, Inc. — Clearwater

North Carolina

  • American Health Research — Charlotte

Oregon

  • Clinical Research Institute of Southern Oregon, PC — Medford

South Carolina

  • Spartanburg Medical Research — Spartanburg

South Australia

  • Respiratory Research Foundation - Burnside War Memorial Hospital — Adelaide

Trial Details

FieldValue
Enrollment Target 118 participants
Start Date 2010-03
Est. Completion 2010-11
Phase Phase 2

Sponsor

Pearl Therapeutics

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01085045

The ClinicalTrials.gov registry entry for NCT01085045 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 118 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pearl Therapeutics, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Chronic Obstructive Pulmonary Disease appearing as the primary indexed condition, and to 5 interventions — of which PT003 MDI is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01085045 reports 16 study locations spanning 12 distinct geographic areas — top geographies include New South Wales, Queensland, Auckland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01085045 about?

NCT01085045 is a clinical study titled "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)". The purpose of this study is to evaluate, after 1 week of dosing, the efficacy and safety of PT003 compared with its individual components (PT001 and PT005), placebo and two active comparators to demonstrate superiority of the combination to its components, and to assess the relative contribution of...

What is the current status of trial NCT01085045?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 118 participants. The study started on 2010-03. Estimated completion is 2010-11.

What conditions does trial NCT01085045 study?

This clinical trial studies the following conditions: Chronic Obstructive Pulmonary Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01085045?

The interventions under investigation include: PT003 MDI (DRUG), PT005 MDI (DRUG), Placebo MDI (DRUG), Tiotropium bromide 18 μg (Spiriva Handihaler®) (DRUG), Formoterol Fumarate 12 μg (Foradil® Aerolizer®) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01085045?

This trial is sponsored by Pearl Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01085045 being conducted?

This trial has 16 study locations across Florida, North Carolina, Oregon, South Carolina, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial