NCT02449018

Brief Summary

To evaluate the efficacy, safety and tolerability of multiple doses of QBW251 vs placebo administered orally, on airway function, lung volume, and quality of life in patients with chronic obstructive pulmonary disease (COPD)

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2015

Geographic Reach
2 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

April 30, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 20, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2016

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2017

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

April 2, 2018

Completed
Last Updated

January 5, 2021

Status Verified

April 1, 2018

Enrollment Period

1.7 years

First QC Date

March 30, 2015

Results QC Date

January 18, 2018

Last Update Submit

December 9, 2020

Conditions

Chronic Obstructive Pulmonary Disease, COPD

Keywords

COPD,chronic bronchitis,inflammation,airway,LCI,pulmonary function test,lung function,controlled clinical trial,randomized,airflow,smoker

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Lung Clearance Index (LCI)

    Change from baseline to Day 29 in LCI as measured by multiple breath nitrogen washout (MBNW) technique. MBNW is the time taken to wash out nitrogen while breathing 100% oxygen.

    Baseline and Day 29

Secondary Outcomes (12)

  • Change From Baseline in FEV1 Pre-bronchodilator

    Day 29

  • Change From Baseline in FEV1 Post-bronchodilator

    Day 29

  • Change From Baseline in FVC Pre Bronchodilator

    Day 29

  • Change From Baseline in FVC Post- Bronchodilator

    Day 29

  • Change From Baseline in TLC

    Day 29

  • +7 more secondary outcomes

Study Arms (2)

QBW251

EXPERIMENTAL

QBW251 will be provided to participants during 70 days

Drug: QBW251

Placebo

PLACEBO COMPARATOR

Placebo will be provided to participants during 70 days

Drug: Placebo

Interventions

QBW251DRUG

QBW251 capsule(s) taken orally twice per day

QBW251
PlaceboDRUG

Matching placebo capsule(s) taken orally twice per day

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Novartis Investigative Site

Birmingham, Alabama, 35294, United States

Location

Novartis Investigative Site

Fullerton, California, 92835, United States

Location

Novartis Investigative Site

Waterbury, Connecticut, 06708, United States

Location

Novartis Investigative Site

Clearwater, Florida, 33765, United States

Location

Novartis Investigative Site

Port Orange, Florida, 32127, United States

Location

Novartis Investigative Site

Tampa, Florida, 33603, United States

Location

Novartis Investigative Site

Normal, Illinois, 61761, United States

Location

Novartis Investigative Site

St Louis, Missouri, 63141, United States

Location

Novartis Investigative Site

Huntersville, North Carolina, 28078, United States

Location

Novartis Investigative Site

Shelby, North Carolina, 28152, United States

Location

Novartis Investigative Site

Medford, Oregon, 97504, United States

Location

Novartis Investigative Site

Simpsonville, South Carolina, 29681, United States

Location

Novartis Investigative Site

Spartanburg, South Carolina, 29303, United States

Location

Novartis Investigative Site

Union, South Carolina, 29379, United States

Location

Novartis Investigative Site

Lodz, 90-153, Poland

Location

Novartis Investigative Site

Sobótka, 55-050, Poland

Location

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveBronchitis, ChronicInflammation

Interventions

icenticaftor

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchitisRespiratory Tract InfectionsInfectionsBronchial Diseases

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
8627781873

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2015

First Posted

May 20, 2015

Study Start

April 30, 2015

Primary Completion

December 27, 2016

Study Completion

January 23, 2017

Last Updated

January 5, 2021

Results First Posted

April 2, 2018

Record last verified: 2018-04

Locations

US(14)PL(2)