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NCT04072887 · ClinicalTrials.gov registry record · Phase 2
Dose-range Finding Efficacy and Safety Study for QBW251 in COPD Patients
A Phase 2 study of Pulmonary Disease, Chronic Obstructive, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 974
- Enrollment target
- 20
- Study locations
NCT04072887: Completed Phase 2 study of Pulmonary Disease, Chronic Obstructive, sponsored by Novartis Pharmaceuticals.
NCT04072887 is a Phase 2 study of Pulmonary Disease, Chronic Obstructive that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 974 participants, roughly in line with the 1,031-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target. The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04072887, a Phase 2 study of Pulmonary Disease, Chronic Obstructive, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 974 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
The primary efficacy analysis assessed the effect of QBW251 on the absolute change from baseline in trough FEV1 in liters on Week 12. Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline measurement was defined as the baseline visit pre-bronchodilator spirometry assessment. Change from baseline in the FEV1 mean scores were analyzed using a Mixed Model for Repeated Measures (MMRM): treatment + baseli
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 974 participants |
| Start Date | 2019-09-12 |
| Est. Completion | 2022-02-01 |
| Phase | Phase 2 |
What the finished NCT04072887 record still lists
NCT04072887 is an interventional study that assigns participants to a tested intervention. The registered 974 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 1,031-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target.
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.
NCT04072887 names 20 study sites across 11 states, led by Florida, Louisiana, North Carolina.
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.
What interventions are being tested in trial NCT04072887?
The interventions under investigation include: Placebo (DRUG), QBW251 (DRUG), COPD maintenance background therapy (DRUG).
Who is sponsoring clinical trial NCT04072887?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT04072887's enrollment target sits among peer trials
974 16th of 74 higher than 59 of 74 other Pulmonary Disease, Chronic Obstructive trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Disease, Chronic Obstructive trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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