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COMPLETED Phase 2

Dose-range Finding Efficacy and Safety Study for QBW251 in COPD Patients

NCT04072887 · View on ClinicalTrials.gov ↗

Study Summary

This clinical study was designed to support the dose selection for future studies by evaluating efficacy and safety of different QBW251 doses in Chronic obstructive pulmonary disease (COPD) patients with chronic bronchitis and a history of exacerbations, compared to placebo, when added to a triple inhaled therapy of LABA, LAMA and ICS.

Interventions

  • DRUG Placebo
  • DRUG QBW251
  • DRUG COPD maintenance background therapy

Study Locations (20)

Florida

  • Novartis Investigative Site — Ormond Beach
  • Novartis Investigative Site — Sarasota
  • Novartis Investigative Site — Winter Park

Louisiana

  • Novartis Investigative Site — Crowley
  • Novartis Investigative Site — New Orleans
  • Novartis Investigative Site — Zachary

North Carolina

  • Novartis Investigative Site — Charlotte
  • Novartis Investigative Site — Gastonia
  • Novartis Investigative Site — Shelby

California

  • Novartis Investigative Site — Los Angeles
  • Novartis Investigative Site — Westminster

Minnesota

  • Novartis Investigative Site — Edina
  • Novartis Investigative Site — Minneapolis

Missouri

  • Novartis Investigative Site — Saint Charles
  • Novartis Investigative Site — St Louis

Alabama

  • Novartis Investigative Site — Andalusia

Kentucky

  • Novartis Investigative Site — Florence

Trial Details

FieldValue
Enrollment Target 974 participants
Start Date 2019-09-12
Est. Completion 2022-02-01
Phase Phase 2

Sponsor

Novartis Pharmaceuticals

792 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04072887

The ClinicalTrials.gov registry entry for NCT04072887 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 974 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 Pulmonary Disease, Chronic Obstructive 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: NCT04072887 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, Louisiana, North 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 NCT04072887 about?

NCT04072887 is a clinical study titled "Dose-range Finding Efficacy and Safety Study for QBW251 in COPD Patients". This clinical study was designed to support the dose selection for future studies by evaluating efficacy and safety of different QBW251 doses in Chronic obstructive pulmonary disease (COPD) patients with chronic bronchitis and a history of exacerbations, compared to placebo, when added to a triple i...

What is the current status of trial NCT04072887?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 974 participants. The study started on 2019-09-12. Estimated completion is 2022-02-01.

What conditions does trial NCT04072887 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 NCT04072887?

The interventions under investigation include: Placebo (DRUG), QBW251 (DRUG), COPD maintenance background therapy (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04072887?

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 NCT04072887 being conducted?

This trial has 20 study locations across Alabama, California, Florida, Kentucky, 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