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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04072887




Registration number
NCT04072887
Ethics application status
Date submitted
7/08/2019
Date registered
28/08/2019

Titles & IDs
Public title
Dose-range Finding Efficacy and Safety Study for QBW251 in COPD Patients
Scientific title
A 24-week Multi-center, Double-blind, Placebo Controlled Dose-range Finding Study to Investigate the Efficacy and Safety of Oral QBW251 in COPD Patients on Triple Inhaled Therapy (LABA / LAMA / ICS)
Secondary ID [1] 0 0
2018-003197-28
Secondary ID [2] 0 0
CQBW251B2201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - QBW251
Treatment: Drugs - Placebo
Treatment: Drugs - COPD maintenance background therapy

Experimental: QBW251 450 mg - QBW251 was orally administered 450 mg b.i.d for 24 weeks

Experimental: QBW251 300 mg - QBW251 was orally administered 300 mg b.i.d for 24 weeks

Experimental: QBW251 150 mg - QBW251 was orally administered 150 mg b.i.d for 24 weeks

Experimental: QBW251 75 mg - QBW251 was orally administered 75 mg b.i.d for 24 weeks

Experimental: QBW251 25 mg - QBW251 was orally administered 25 mg b.i.d for 24 weeks

Placebo comparator: Placebo - Placebo was orally administered b.i.d for 24 weeks


Treatment: Drugs: QBW251
QBW251 oral capsules (450, 300, 150, 75 and 25 mg) of identical appearance to ensure blinding administered twice a day (b.i.d) for 24 weeks

Treatment: Drugs: Placebo
Placebo oral capsules administered twice a day for 24 weeks

Treatment: Drugs: COPD maintenance background therapy
Combination of fluticasone furoate, vilanterol and umeclidinium bromide
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 12
Timepoint [1] 0 0
Baseline and Week 12
Secondary outcome [1] 0 0
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Timepoint [1] 0 0
Baseline, weeks 4, 8, 16, 20 and 24
Secondary outcome [2] 0 0
Change From Baseline in Evaluating Respiratory Symptoms (E-RS); Total Score
Timepoint [2] 0 0
Baseline, weeks 12 and 24
Secondary outcome [3] 0 0
Change From Baseline in Evaluating Respiratory Symptoms (E-RS); Cough and Sputum Score
Timepoint [3] 0 0
Baseline, weeks 12 and 24
Secondary outcome [4] 0 0
Number of Participants With a "Better" Change in the Patient Global Impression of Severity (PGI-S) From Baseline
Timepoint [4] 0 0
Baseline, weeks 12 and 24
Secondary outcome [5] 0 0
Change From Baseline in the Cough and Sputum Assessment Questionnaire (CASA-Q)
Timepoint [5] 0 0
Baseline, weeks 12 and 24
Secondary outcome [6] 0 0
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ)
Timepoint [6] 0 0
Baseline, weeks 12 and 24
Secondary outcome [7] 0 0
Minimum Plasma Concentration (Cmin) for QBW251
Timepoint [7] 0 0
Pre-dose on Days 15, 29, 57, 85, 113, 141 and 169
Secondary outcome [8] 0 0
Maximum Plasma Concentration (Cmax) for QBW251
Timepoint [8] 0 0
Days 1, 15 and 169
Secondary outcome [9] 0 0
Maximum Plasma Concentration (Cmax) for QBW251 in Serial PK Set
Timepoint [9] 0 0
1, 2, 4, 6, and 8 hours post-dose on Days 1 and 15
Secondary outcome [10] 0 0
Area Under the Curve From Time 0 to 24 Hours (AUC0-24h) of QBW251 in Serial PK Set
Timepoint [10] 0 0
1, 2, 4, 6, and 8 hours post-dose on Days 1 and 15

Eligibility
Key inclusion criteria
* Male and female COPD patients aged =40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
* Current or ex-smokers who have a smoking history of at least 10 pack years.
* Patients who have been treated with a triple combination of LABA/LAMA/ICS for the last 3 months prior to screening.
* Patients featuring chronic bronchitis
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients who have had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization, or a respiratory tract infection in the 4 weeks prior to screening, or between screening and randomization.
* Patients with any documented history of asthma, or with an onset of chronic respiratory symptoms, including a COPD diagnosis, prior to age 40 years.
* Patients with a body mass index (BMI) of more than 40 kg/m2.
* Use of other investigational drugs (approved or unapproved) within 30 days or 5 half-lives prior to screening, or until the expected pharmacodynamic effect has returned to baseline (e.g., biologics), whichever is longer; or longer if required by local regulations.
* Pregnant or nursing (lactating) women, and women of childbearing potential not willing to use acceptable effective methods of contraception during study participation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2022
Sample size
Target
Accrual to date
Final
974
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - South Brisbane
Recruitment hospital [2] 0 0
Novartis Investigative Site - Clayton
Recruitment hospital [3] 0 0
Novartis Investigative Site - Footscray
Recruitment hospital [4] 0 0
Novartis Investigative Site - Spearwood
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3011 - Footscray
Recruitment postcode(s) [4] 0 0
6163 - Spearwood
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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California
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United States of America
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Florida
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Kentucky
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United States of America
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Louisiana
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United States of America
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Michigan
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United States of America
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Minnesota
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United States of America
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Missouri
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United States of America
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Nebraska
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United States of America
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North Carolina
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Ohio
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Oregon
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Texas
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Virginia
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Argentina
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Buenos Aires
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Argentina
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Entre Ríos
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Argentina
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Santa Fe
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Argentina
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Ciudad Autonoma de Bs As
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Argentina
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Mendoza
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Salta
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Austria
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Feldbach
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Austria
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Grieskirchen
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Thalheim bei Wels
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Belgium
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Erpent
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Belgium
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Leuven
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Belgium
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Liege
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Canada
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Alberta
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Quebec
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Colombia
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Cundinamarca
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Czech Republic
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Czechia
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Varnsdorf
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Aalborg
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Copenhagen
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Hvidovre
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Herault
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France
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Reims
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Halle
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Landsberg
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Leipzig
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Mainz
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Marburg
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Witten
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GTM
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Godollo
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Mako
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GE
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VR
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Aichi
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Japan
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Fukuoka
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Gifu
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Hokkaido
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Ibaraki
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Seocho Gu
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Daegu
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Incheon
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Netherlands
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Manila
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Grudziadz
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Katowice
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Zawadzkie
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Slovakia
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Slovak Republic
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Poprad
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Presov
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Spisska Nova Ves
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Slovakia
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Vysne Hagy
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Spain
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Andalucia
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Spain
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Comunidad Valenciana
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Spain
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Girona
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Thailand
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Hat Yai
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Thailand
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THA
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Thailand
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Bangkok
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Turkey
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Adana
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Turkey
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Mersin
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United Kingdom
State/province [100] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04072887