Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Date last updated
28/04/2023

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
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
Nebraska
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
Argentina
State/province [15] 0 0
Buenos Aires
Country [16] 0 0
Argentina
State/province [16] 0 0
Entre Ríos
Country [17] 0 0
Argentina
State/province [17] 0 0
Santa Fe
Country [18] 0 0
Argentina
State/province [18] 0 0
Ciudad Autonoma de Bs As
Country [19] 0 0
Argentina
State/province [19] 0 0
Mendoza
Country [20] 0 0
Argentina
State/province [20] 0 0
Salta
Country [21] 0 0
Austria
State/province [21] 0 0
Feldbach
Country [22] 0 0
Austria
State/province [22] 0 0
Grieskirchen
Country [23] 0 0
Austria
State/province [23] 0 0
Thalheim bei Wels
Country [24] 0 0
Belgium
State/province [24] 0 0
Erpent
Country [25] 0 0
Belgium
State/province [25] 0 0
Leuven
Country [26] 0 0
Belgium
State/province [26] 0 0
Liege
Country [27] 0 0
Canada
State/province [27] 0 0
Alberta
Country [28] 0 0
Canada
State/province [28] 0 0
Quebec
Country [29] 0 0
Colombia
State/province [29] 0 0
Cundinamarca
Country [30] 0 0
Czechia
State/province [30] 0 0
Czech Republic
Country [31] 0 0
Czechia
State/province [31] 0 0
Varnsdorf
Country [32] 0 0
Denmark
State/province [32] 0 0
Aalborg
Country [33] 0 0
Denmark
State/province [33] 0 0
Copenhagen
Country [34] 0 0
Denmark
State/province [34] 0 0
Hvidovre
Country [35] 0 0
France
State/province [35] 0 0
Herault
Country [36] 0 0
France
State/province [36] 0 0
Lyon Cedex 04
Country [37] 0 0
France
State/province [37] 0 0
Pessac Cedex
Country [38] 0 0
France
State/province [38] 0 0
Reims
Country [39] 0 0
Germany
State/province [39] 0 0
Berlin
Country [40] 0 0
Germany
State/province [40] 0 0
Frankfurt
Country [41] 0 0
Germany
State/province [41] 0 0
Halle
Country [42] 0 0
Germany
State/province [42] 0 0
Hamburg
Country [43] 0 0
Germany
State/province [43] 0 0
Landsberg
Country [44] 0 0
Germany
State/province [44] 0 0
Leipzig
Country [45] 0 0
Germany
State/province [45] 0 0
Mainz
Country [46] 0 0
Germany
State/province [46] 0 0
Marburg
Country [47] 0 0
Germany
State/province [47] 0 0
Mittweida
Country [48] 0 0
Germany
State/province [48] 0 0
Witten
Country [49] 0 0
Greece
State/province [49] 0 0
GR
Country [50] 0 0
Greece
State/province [50] 0 0
Heraklion Crete
Country [51] 0 0
Guatemala
State/province [51] 0 0
GTM
Country [52] 0 0
Guatemala
State/province [52] 0 0
Guatemala City
Country [53] 0 0
Hong Kong
State/province [53] 0 0
New Territories
Country [54] 0 0
Hong Kong
State/province [54] 0 0
Pokfulam
Country [55] 0 0
Hungary
State/province [55] 0 0
Budapest
Country [56] 0 0
Hungary
State/province [56] 0 0
Godollo
Country [57] 0 0
Hungary
State/province [57] 0 0
Komarom
Country [58] 0 0
Hungary
State/province [58] 0 0
Mako
Country [59] 0 0
Hungary
State/province [59] 0 0
Pecs
Country [60] 0 0
Italy
State/province [60] 0 0
GE
Country [61] 0 0
Italy
State/province [61] 0 0
SI
Country [62] 0 0
Italy
State/province [62] 0 0
VR
Country [63] 0 0
Japan
State/province [63] 0 0
Aichi
Country [64] 0 0
Japan
State/province [64] 0 0
Fukuoka
Country [65] 0 0
Japan
State/province [65] 0 0
Gifu
Country [66] 0 0
Japan
State/province [66] 0 0
Hokkaido
Country [67] 0 0
Japan
State/province [67] 0 0
Ibaraki
Country [68] 0 0
Japan
State/province [68] 0 0
Kanagawa
Country [69] 0 0
Japan
State/province [69] 0 0
Mie
Country [70] 0 0
Japan
State/province [70] 0 0
Miyagi
Country [71] 0 0
Japan
State/province [71] 0 0
Osaka
Country [72] 0 0
Japan
State/province [72] 0 0
Tokyo
Country [73] 0 0
Japan
State/province [73] 0 0
Yamagata
Country [74] 0 0
Korea, Republic of
State/province [74] 0 0
Seocho Gu
Country [75] 0 0
Korea, Republic of
State/province [75] 0 0
Daegu
Country [76] 0 0
Korea, Republic of
State/province [76] 0 0
Incheon
Country [77] 0 0
Netherlands
State/province [77] 0 0
Eindhoven
Country [78] 0 0
Netherlands
State/province [78] 0 0
Harderwijk
Country [79] 0 0
Philippines
State/province [79] 0 0
Batangas
Country [80] 0 0
Philippines
State/province [80] 0 0
Iloilo
Country [81] 0 0
Philippines
State/province [81] 0 0
Bulacan
Country [82] 0 0
Philippines
State/province [82] 0 0
Iloilo City
Country [83] 0 0
Philippines
State/province [83] 0 0
Manila
Country [84] 0 0
Poland
State/province [84] 0 0
Grudziadz
Country [85] 0 0
Poland
State/province [85] 0 0
Katowice
Country [86] 0 0
Poland
State/province [86] 0 0
Zawadzkie
Country [87] 0 0
Slovakia
State/province [87] 0 0
Slovak Republic
Country [88] 0 0
Slovakia
State/province [88] 0 0
Poprad
Country [89] 0 0
Slovakia
State/province [89] 0 0
Presov
Country [90] 0 0
Slovakia
State/province [90] 0 0
Spisska Nova Ves
Country [91] 0 0
Slovakia
State/province [91] 0 0
Vysne Hagy
Country [92] 0 0
Spain
State/province [92] 0 0
Andalucia
Country [93] 0 0
Spain
State/province [93] 0 0
Comunidad Valenciana
Country [94] 0 0
Spain
State/province [94] 0 0
Girona
Country [95] 0 0
Thailand
State/province [95] 0 0
Hat Yai
Country [96] 0 0
Thailand
State/province [96] 0 0
THA
Country [97] 0 0
Thailand
State/province [97] 0 0
Bangkok
Country [98] 0 0
Turkey
State/province [98] 0 0
Adana
Country [99] 0 0
Turkey
State/province [99] 0 0
Mersin
Country [100] 0 0
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
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.
Trial website
https://clinicaltrials.gov/study/NCT04072887
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04072887