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COMPLETED Phase 3

Determine the Safety and Efficacy of (R,R)-Formoterol in the Treatment of Subjects With COPD

NCT00064402 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to assess the bronchodilator effect and safety of multiple daily doses of arformoterol administered for 12 weeks as maintenance treatment in patients with COPD

Interventions

  • DRUG Placebo
  • DRUG Salmeterol
  • DRUG arformoterol tartrate inhalation solution

Study Locations (20)

California

  • Northern California Research Corp. — Fair Oaks
  • SARC Research Center — Fresno
  • California Research Medical Group, Inc. — Fullerton
  • Radiant Research-Irvine — Irvine
  • West Coast Clinical Trials — Newport Beach
  • Center for Clinical Trials, LLC — Paramount
  • Advances in Medicine — Rancho Mirage
  • Institute of Healthcare Assessment, Inc. — San Diego
  • San Jose Clinical Research — San Jose
  • Allergy & Asthma Medical Group of Diablo Valley, Inc. — Walnut Creek

Florida

  • Clinical Research of West Florida, Inc. — Clearwater
  • University Clinical Research, DeLand — DeLand
  • Mt. Sinai Medical Center — Miami Beach

Arizona

  • Pulmonary Associates, PA — Phoenix
  • Arizona Clinical Research Center, Inc. — Tucson

Colorado

  • Colorado Pulmonary Associates — Denver
  • Northern Colorado Pulmonary Consultants, PC — Fort Collins

Alabama

  • Pulmonary & Sleep Associates of Jasper, PC — Jasper

Connecticut

  • Physicians Research Center, Inc. — Hartford

District of Columbia

  • Washington Hospital Center — Washington D.C.

Trial Details

FieldValue
Enrollment Target 741 participants
Start Date 2002-04
Est. Completion 2004-03
Phase Phase 3

Sponsor

Sumitomo Pharma America

65 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00064402

The ClinicalTrials.gov registry entry for NCT00064402 describes a study currently listed as completed. It is categorized as Phase 3, 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 741 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sumitomo Pharma America, which has 65 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Chronic Obstructive Pulmonary Disease appearing as the primary indexed condition, and to 3 interventions — of which Placebo 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: NCT00064402 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Florida, Arizona. 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 NCT00064402 about?

NCT00064402 is a clinical study titled "Determine the Safety and Efficacy of (R,R)-Formoterol in the Treatment of Subjects With COPD". The purpose of this study is to assess the bronchodilator effect and safety of multiple daily doses of arformoterol administered for 12 weeks as maintenance treatment in patients with COPD

What is the current status of trial NCT00064402?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 741 participants. The study started on 2002-04. Estimated completion is 2004-03.

What conditions does trial NCT00064402 study?

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

What interventions are being tested in trial NCT00064402?

The interventions under investigation include: Placebo (DRUG), Salmeterol (DRUG), arformoterol tartrate inhalation solution (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00064402?

This trial is sponsored by Sumitomo Pharma America, which has 65 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00064402 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. 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