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COMPLETED Phase 4

Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent® Inhalation Aerosol in COPD Patients.

NCT00388882 · View on ClinicalTrials.gov ↗

Study Summary

The objective of this study is to evaluate the efficacy and safety of 12 weeks treatment with tiotro pium HandiHaler® 18 mcg daily compared to Combivent® MDI CFC Inhalation Aerosol 2 actuations qid in COPD patients currently prescribed Combivent® MDI.

Interventions

  • DRUG tiotropium
  • DRUG ipratropium bromide / albuterol

Study Locations (20)

Other

  • 205.346.510 — Bs As
  • 205.346.502 — Buenos Aires
  • 205.346.503 — Buenos Aires
  • 205.346.508 — Buenos Airess
  • 205.346.505 — Mendoza
  • 205.346.509 — Rosario, Santa Fe
  • 205.346.511 — Rosario, Santa Fé
  • 205.346.504 Instituto de Patologías Respiratorias — San Miguel de Tucumán
  • 205.346.401 Boehringer Ingelheim Investigational Site — Alytus
  • 205.346.404 Boehringer Ingelheim Investigational Site — Kaunas

California

  • 205.346.104 Boehringer Ingelheim Investigational Site — Lakewood
  • 205.346.108 Boehringer Ingelheim Investigational Site — Sepulveda
  • 205.346.101 Boehringer Ingelheim Investigational Site — Torrance

South Carolina

  • 205.346.105 Boehringer Ingelheim Investigational Site — Charleston
  • 205.346.103 Boehringer Ingelheim Investigational Site — Spartanburg

Arizona

  • 205.346.107 Boehringer Ingelheim Investigational Site — Phoenix

Colorado

  • 205.346.106 Boehringer Ingelheim Investigational Site — Wheat Ridge

Idaho

  • 205.346.102 Boehringer Ingelheim Investigational Site — Coeur d'Alene

Louisiana

  • 205.346.109 Boehringer Ingelheim Investigational Site — Shreveport

Pennsylvania

  • 205.346.110 Boehringer Ingelheim Investigational Site — Philadelphia

Trial Details

FieldValue
Enrollment Target 327 participants
Start Date 2006-10-04
Phase Phase 4

Sponsor

Boehringer Ingelheim

203 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00388882

The ClinicalTrials.gov registry entry for NCT00388882 describes a study currently listed as completed. It is categorized as Phase 4, 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 327 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 1 condition, with Pulmonary Disease, Chronic Obstructive appearing as the primary indexed condition, and to 2 interventions — of which tiotropium 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: NCT00388882 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, California, South Carolina. 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 NCT00388882 about?

NCT00388882 is a clinical study titled "Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent® Inhalation Aerosol in COPD Patients.". The objective of this study is to evaluate the efficacy and safety of 12 weeks treatment with tiotro pium HandiHaler® 18 mcg daily compared to Combivent® MDI CFC Inhalation Aerosol 2 actuations qid in COPD patients currently prescribed Combivent® MDI.

What is the current status of trial NCT00388882?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 327 participants. The study started on 2006-10-04.

What conditions does trial NCT00388882 study?

This clinical trial studies the following conditions: 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 NCT00388882?

The interventions under investigation include: tiotropium (DRUG), ipratropium bromide / albuterol (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00388882?

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 NCT00388882 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Idaho, Louisiana. 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