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COMPLETED Phase 3

Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease

NCT00877383 · View on ClinicalTrials.gov ↗

Study Summary

This study assessed the efficacy and safety of indacaterol (150 µg once daily \[od\]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD).

Interventions

  • DRUG Placebo to indacaterol
  • DRUG Indacaterol 150 μg
  • DRUG Tiotropium 18 μg

Study Locations (20)

California

  • Novartis Investigator Site — Buena Park
  • Novartis Investigator Site — Fullerton
  • Novartis Investigator Site — Mission Viejo
  • Novartis Investigator Site — San Ramon
  • Novartis Investigator Site — Santa Barbara
  • Novartis Investigator Site — Sepulveda
  • Novartis Investigator Site — Spring Valley
  • Novartis Investigator Site — Torrance
  • Novartis Investigator Site — Torrance
  • Novartis Investigator Site — Vista

Alabama

  • Novartis Investigator Site — Anniston
  • Novartis Investigator Site — Birmingham
  • Novartis Investigator Site — Jasper
  • Novartis Investigator Site — Mobile

Arizona

  • Novartis Investigator Site — Glendale
  • Novartis Investigator Site — Phoenix
  • Novartis Investigator Site — Phoenix
  • Novartis Investigator Site — Scottsdale

Arkansas

  • Novartis Investigator Site — Little Rock

Colorado

  • Novartis Investigator Site — Boulder

Trial Details

FieldValue
Enrollment Target 1,142 participants
Start Date 2009-04
Est. Completion 2010-02
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

792 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00877383

The ClinicalTrials.gov registry entry for NCT00877383 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 1,142 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 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 (COPD) appearing as the primary indexed condition, and to 3 interventions — of which Placebo to indacaterol 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: NCT00877383 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Alabama, 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 NCT00877383 about?

NCT00877383 is a clinical study titled "Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease". This study assessed the efficacy and safety of indacaterol (150 µg once daily \[od\]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD).

What is the current status of trial NCT00877383?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,142 participants. The study started on 2009-04. Estimated completion is 2010-02.

What conditions does trial NCT00877383 study?

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

What interventions are being tested in trial NCT00877383?

The interventions under investigation include: Placebo to indacaterol (DRUG), Indacaterol 150 μg (DRUG), Tiotropium 18 μg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00877383?

This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00877383 being conducted?

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