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COMPLETED Phase 2

Efficacy and Safety of 4 Weeks Treatment With Inhaled BI 1744 CL in Patients With COPD.

NCT00452400 · View on ClinicalTrials.gov ↗

Study Summary

The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL inhalation solution delivered by the Respimat® inhaler for four weeks in patients with chronic obstructive pulmonary disease (COPD). The selection of the optimum dose(s) will be based on bronchodilator efficacy (how well it helps your breathing), safety evaluations and pharmacokinetic evaluations (the amount of the medication found in your blood).

Interventions

  • DRUG BI 1744CL

Study Locations (20)

Colorado

  • 1222.5.14 Boehringer Ingelheim Investigational Site — Denver
  • 1222.5.13 Boehringer Ingelheim Investigational Site — Wheat Ridge
  • 1222.5.17 Boehringer Ingelheim Investigational Site — Wheat Ridge

South Carolina

  • 1222.5.08 Boehringer Ingelheim Investigational Site — Charleston
  • 1222.5.19 Boehringer Ingelheim Investigational Site — Charleston
  • 1222.5.06 Boehringer Ingelheim Investigational Site — Spartanburg

Pennsylvania

  • 1222.5.05 Boehringer Ingelheim Investigational Site — Hershey
  • 1222.5.02 Boehringer Ingelheim Investigational Site — Philadelphia

Texas

  • 1222.5.21 Boehringer Ingelheim Investigational Site — Kileen
  • 1222.5.01 Boehringer Ingelheim Investigational Site — San Antonio

Alabama

  • 1222.5.03 Boehringer Ingelheim Investigational Site — Birmingham

California

  • 1222.5.07 Boehringer Ingelheim Investigational Site — Lakewood

Connecticut

  • 1222.5.18 Boehringer Ingelheim Investigational Site — Stamford

Florida

  • 1222.5.15 Boehringer Ingelheim Investigational Site — Panama City

Trial Details

FieldValue
Enrollment Target 409 participants
Start Date 2007-03
Phase Phase 2

Sponsor

Boehringer Ingelheim

203 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00452400

The ClinicalTrials.gov registry entry for NCT00452400 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 409 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Asthma appearing as the primary indexed condition, and to 1 intervention — of which BI 1744CL 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: NCT00452400 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Colorado, South Carolina, Pennsylvania. 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 NCT00452400 about?

NCT00452400 is a clinical study titled "Efficacy and Safety of 4 Weeks Treatment With Inhaled BI 1744 CL in Patients With COPD.". The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL inhalation solution delivered by the Respimat® inhaler for four weeks in patients with chronic obstructive pulmonary disease (COPD). The selection of the optimum dose(s) will be based on bronchodilator efficacy (ho...

What is the current status of trial NCT00452400?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 409 participants. The study started on 2007-03.

What conditions does trial NCT00452400 study?

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

What interventions are being tested in trial NCT00452400?

The interventions under investigation include: BI 1744CL (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00452400?

This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00452400 being conducted?

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