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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

QBW251

Placebo

COPD maintenance background therapy

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring COPD

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Arm Label

QBW251 450 mg

QBW251 300 mg

QBW251 150 mg

QBW251 75 mg

QBW251 25 mg

Placebo

Arm Description

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

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

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

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

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

Placebo was orally administered b.i.d for 24 weeks

Outcomes

Primary Outcome Measures

Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 12

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 + baseline score + smoking status at screening + run-in FEV1 + airflow limitation severity + region + time interval + treatment*time interval interaction + baseline score*time interval interaction.

Secondary Outcome Measures

Change From Baseline in Forced Expiratory Volume in One Second (FEV1)

The primary efficacy analysis assessed the effect of QBW251 on the absolute change from baseline in trough FEV1 in liters compared to placebo on Weeks 4, 8, 16, 20 and 24. 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. A positive trend for change from baseline in FEV1 across the dose range is considered a favorable outcome.

Change From Baseline in Evaluating Respiratory Symptoms (E-RS); Total Score

The E-RS assesses overall daily respiratory COPD symptoms (Total score) and it is derived as the sum of 11 severity items; a higher scores indicate more severe symptoms. E-RS total score has a range of 0 to 40. Change from baseline in the E-RS Total weekly mean scores were analyzed using a Mixed Model for Repeated Measures (MMRM): treatment + baseline score + smoking status at screening + run-in E-RS + airflow limitation severity + region + time interval + treatment*time interval interaction + baseline score*time interval interaction. The mean baseline E-RS Total score was the average of the corresponding daily scores from the run-in period. A negative change from baseline corresponds to improvement in symptoms severity.

Change From Baseline in Evaluating Respiratory Symptoms (E-RS); Cough and Sputum Score

The E-RS assesses both overall daily respiratory COPD symptoms (Total score) and specific respiratory symptoms using 3 subscales (Breathlessness, Cough & Sputum, and Chest Symptoms). The E-RS comprises 11 severity items and higher scores indicate more severe symptoms. The Cough and Sputum subscale score has a range of 0 to 11 and was derived as the sum of items 2 - 4. Change from baseline in the E-RS Cough and Sputum weekly mean scores were analyzed using a Mixed Model for Repeated Measures (MMRM): treatment + baseline score + smoking status at screening + run-in E-RS + airflow limitation severity + region + time interval + treatment*time interval interaction + baseline score*time interval interaction. The mean baseline E-RS Cough & Sputum subscale score was the average of the corresponding daily scores from the run-in period. Lower scores in the change from baseline correspond to lower symptom severity.

Number of Participants With a "Better" Change in the Patient Global Impression of Severity (PGI-S) From Baseline

The PGI-S questionnaire is a patient-reported outcomes score that rates the severity of the respiratory symptoms and of cough and mucus. The change in severity scores (Better, No change and Worse) from baseline were reported at weeks 12 and 24. Thus, the number of participants with a Better change in the severity score are reported in the table below.

Change From Baseline in the Cough and Sputum Assessment Questionnaire (CASA-Q)

The CASA-Q is a validated questionnaire instrument used to measure cough and sputum production, and their impact in patients COPD and/or chronic bronchitis. It contains a total of 20 items on a 5-step scale distributed in 4 domains: Cough symptoms, Cough impact, Sputum symptoms and Sputum impact. All items are rescored from 1-5 to 0-4 and then reverse scored such that better responses have higher scores. The four domains are ranged from 0-100 where higher scores associated with fewer symptoms/less impact due to cough or sputum. Change from baseline in the CASA-Q cough and symptoms scores were analyzed using a Mixed Model for Repeated Measures (MMRM): treatment + baseline score + smoking status at screening + run-in E-RS + airflow limitation severity + region + time interval + treatment*time interval interaction + baseline score*time interval interaction.

Change From Baseline in St. George's Respiratory Questionnaire (SGRQ)

SGRQ measures health impairment and contains 50 items divided into three components: Symptoms, Activity and Impacts. A score was calculated for each component and a "Total" score was also calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of quality of life. Change from baseline in the SGRQ scores were analyzed using a Mixed Model for Repeated Measures (MMRM): treatment + baseline score + smoking status at screening + baseline SGRQ score + airflow limitation severity + region + time interval + treatment*time interval interaction + baseline score*time interval interaction.

Minimum Plasma Concentration (Cmin) for QBW251

Venous whole blood samples were collected for pharmacokinetics characterization. Cmin was measured pre dose at all visits and was summarized using descriptive statistics. All concentrations below the lower limit of quantification (LLOQ) were treated as zero.

Maximum Plasma Concentration (Cmax) for QBW251

Venous whole blood samples were collected for pharmacokinetics characterization. Cmax was calculated from plasma concentration data using non-compartmental methods and summarized using descriptive statistics. Cmax was measured in the samples taken at 3 hours post-dose with the exception of the participants included in the Serial PK set on Days 1 and 15 for whom all samples (1, 2, 4, 6, and 8 hours post-dose) were taken into consideration for the measurement of Cmax. All concentrations below the lower limit of quantification (LLOQ) were treated as zero.

Maximum Plasma Concentration (Cmax) for QBW251 in Serial PK Set

Area Under the Curve From Time 0 to 24 Hours (AUC0-24h) of QBW251 in Serial PK Set

Venous whole blood samples were collected for pharmacokinetics characterization. AUC0-24h was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. All concentrations below the lower limit of quantification (LLOQ) were treated as zero.

Full Information

NCT ID

NCT04072887

First Posted

August 7, 2019

Last Updated

April 6, 2023

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT04072887

Brief Title

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

Official 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)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

September 12, 2019 (Actual)

Primary Completion Date

October 8, 2021 (Actual)

Study Completion Date

February 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

This study used a 6 treatment arm, parallel-group, randomized, double-blind study design. 974 male and female COPD patients were randomized into the trial. The study consisted of four distinct study periods: Screening (Weeks -3 to -2): Participants underwent a screening period of 1 week where were assessed for eligibility and tapered off disallowed medications. Run-in (Days -14 to 1): Subsequently, participants entered the run-in period of up to 2 weeks to establish baseline values for symptom assessments, to standardize the COPD background therapy (triple combination LABA/LAMA/ICS), and to complete eligibility assessments. Treatment (Day 1 to Week 24): Eligible participants moved into the Day 1 visit where they were stratified according to their smoking status (current or ex-smoker) and severity of airflow limitation (FEV1 ≥ 30% to < 50% and ≥ 50% to < 80%) and then randomized into 1 of 6 treatment arms with a randomization ratio of 2:2:1:1:1:2 (450 mg b.i.d., 300 mg b.i.d., 150 mg b.i.d., 75 mg b.i.d., 25 mg b.i.d., placebo). The treatment period consisted of 24 weeks, during which the participant returned to the site for regular visits (Day 1 - Week 24). QBW251 450 mg arm was discontinued early based on a pre-defined pharmacokinetic exposure stopping rule. Follow-up (Weeks 25-28): Upon completion of the treatment period, participants were followed up for safety assessments for 30 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Disease, Chronic Obstructive

Keywords

COPD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

974 (Actual)

8. Arms, Groups, and Interventions

Arm Title

QBW251 450 mg

Arm Type

Experimental

Arm Description

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

Arm Title

QBW251 300 mg

Arm Type

Experimental

Arm Description

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

Arm Title

QBW251 150 mg

Arm Type

Experimental

Arm Description

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

Arm Title

QBW251 75 mg

Arm Type

Experimental

Arm Description

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

Arm Title

QBW251 25 mg

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo was orally administered b.i.d for 24 weeks

Intervention Type

Drug

Intervention Name(s)

QBW251

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo oral capsules administered twice a day for 24 weeks

Intervention Type

Drug

Intervention Name(s)

COPD maintenance background therapy

Intervention Description

Combination of fluticasone furoate, vilanterol and umeclidinium bromide

Primary Outcome Measure Information:

Title

Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 12

Description

Time Frame

Baseline and Week 12

Secondary Outcome Measure Information:

Title

Change From Baseline in Forced Expiratory Volume in One Second (FEV1)

Description

Time Frame

Baseline, weeks 4, 8, 16, 20 and 24

Title

Change From Baseline in Evaluating Respiratory Symptoms (E-RS); Total Score

Description

Time Frame

Baseline, weeks 12 and 24

Title

Change From Baseline in Evaluating Respiratory Symptoms (E-RS); Cough and Sputum Score

Description

Time Frame

Baseline, weeks 12 and 24

Title

Number of Participants With a "Better" Change in the Patient Global Impression of Severity (PGI-S) From Baseline

Description

Time Frame

Baseline, weeks 12 and 24

Title

Change From Baseline in the Cough and Sputum Assessment Questionnaire (CASA-Q)

Description

Time Frame

Baseline, weeks 12 and 24

Title

Change From Baseline in St. George's Respiratory Questionnaire (SGRQ)

Description

Time Frame

Baseline, weeks 12 and 24

Title

Minimum Plasma Concentration (Cmin) for QBW251

Description

Time Frame

Pre-dose on Days 15, 29, 57, 85, 113, 141 and 169

Title

Maximum Plasma Concentration (Cmax) for QBW251

Description

Time Frame

Days 1, 15 and 169

Title

Maximum Plasma Concentration (Cmax) for QBW251 in Serial PK Set

Description

Time Frame

1, 2, 4, 6, and 8 hours post-dose on Days 1 and 15

Title

Area Under the Curve From Time 0 to 24 Hours (AUC0-24h) of QBW251 in Serial PK Set

Description

Time Frame

1, 2, 4, 6, and 8 hours post-dose on Days 1 and 15

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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.

Facility Information:

Facility Name

Novartis Investigative Site

City

Andalusia

State/Province

Alabama

ZIP/Postal Code

36420

Country

United States

Facility Name

Novartis Investigative Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90025

Country

United States

Facility Name

Novartis Investigative Site

City

Westminster

State/Province

California

ZIP/Postal Code

92683

Country

United States

Facility Name

Novartis Investigative Site

City

Ormond Beach

State/Province

Florida

ZIP/Postal Code

32174

Country

United States

Facility Name

Novartis Investigative Site

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34233

Country

United States

Facility Name

Novartis Investigative Site

City

Winter Park

State/Province

Florida

ZIP/Postal Code

32789

Country

United States

Facility Name

Novartis Investigative Site

City

Florence

State/Province

Kentucky

ZIP/Postal Code

41042

Country

United States

Facility Name

Novartis Investigative Site

City

Crowley

State/Province

Louisiana

ZIP/Postal Code

70526

Country

United States

Facility Name

Novartis Investigative Site

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70115

Country

United States

Facility Name

Novartis Investigative Site

City

Zachary

State/Province

Louisiana

ZIP/Postal Code

70791

Country

United States

Facility Name

Novartis Investigative Site

City

Livonia

State/Province

Michigan

ZIP/Postal Code

48152

Country

United States

Facility Name

Novartis Investigative Site

City

Edina

State/Province

Minnesota

ZIP/Postal Code

55435

Country

United States

Facility Name

Novartis Investigative Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55407

Country

United States

Facility Name

Novartis Investigative Site

City

Saint Charles

State/Province

Missouri

ZIP/Postal Code

63301

Country

United States

Facility Name

Novartis Investigative Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Novartis Investigative Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68134

Country

United States

Facility Name

Novartis Investigative Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28207

Country

United States

Facility Name

Novartis Investigative Site

City

Gastonia

State/Province

North Carolina

ZIP/Postal Code

28054

Country

United States

Facility Name

Novartis Investigative Site

City

Shelby

State/Province

North Carolina

ZIP/Postal Code

28150

Country

United States

Facility Name

Novartis Investigative Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43215

Country

United States

Facility Name

Novartis Investigative Site

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504

Country

United States

Facility Name

Novartis Investigative Site

City

El Paso

State/Province

Texas

ZIP/Postal Code

79903

Country

United States

Facility Name

Novartis Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Novartis Investigative Site

City

McKinney

State/Province

Texas

ZIP/Postal Code

75069

Country

United States

Facility Name

Novartis Investigative Site

City

Midlothian

State/Province

Virginia

ZIP/Postal Code

23114

Country

United States

Facility Name

Novartis Investigative Site

City

Berazategui

State/Province

Buenos Aires

ZIP/Postal Code

1888

Country

Argentina

Facility Name

Novartis Investigative Site

City

Mar del Plata

State/Province

Buenos Aires

ZIP/Postal Code

7600

Country

Argentina

Facility Name

Novartis Investigative Site

City

Concepcion del Uruguay

State/Province

Entre Ríos

ZIP/Postal Code

3260

Country

Argentina

Facility Name

Novartis Investigative Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000AII

Country

Argentina

Facility Name

Novartis Investigative Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000DBS

Country

Argentina

Facility Name

Novartis Investigative Site

City

Ciudad Autonoma de Bs As

ZIP/Postal Code

C1425FVH

Country

Argentina

Facility Name

Novartis Investigative Site

City

Mendoza

ZIP/Postal Code

5500

Country

Argentina

Facility Name

Novartis Investigative Site

City

Mendoza

ZIP/Postal Code

M5500CBA

Country

Argentina

Facility Name

Novartis Investigative Site

City

Salta

ZIP/Postal Code

4000

Country

Argentina

Facility Name

Novartis Investigative Site

City

Santa Fe

ZIP/Postal Code

S3000FIL

Country

Argentina

Facility Name

Novartis Investigative Site

City

South Brisbane

State/Province

Queensland

ZIP/Postal Code

4101

Country

Australia

Facility Name

Novartis Investigative Site

City

Clayton

State/Province

Victoria

ZIP/Postal Code

3168

Country

Australia

Facility Name

Novartis Investigative Site

City

Footscray

State/Province

Victoria

ZIP/Postal Code

3011

Country

Australia

Facility Name

Novartis Investigative Site

City

Spearwood

State/Province

Western Australia

ZIP/Postal Code

6163

Country

Australia

Facility Name

Novartis Investigative Site

City

Feldbach

ZIP/Postal Code

8330

Country

Austria

Facility Name

Novartis Investigative Site

City

Grieskirchen

ZIP/Postal Code

4710

Country

Austria

Facility Name

Novartis Investigative Site

City

Thalheim bei Wels

ZIP/Postal Code

4600

Country

Austria

Facility Name

Novartis Investigative Site

City

Erpent

ZIP/Postal Code

5100

Country

Belgium

Facility Name

Novartis Investigative Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Sherwood Park

State/Province

Alberta

ZIP/Postal Code

T8H 0N2

Country

Canada

Facility Name

Novartis Investigative Site

City

Sainte Foy

State/Province

Quebec

ZIP/Postal Code

G1V 4G5

Country

Canada

Facility Name

Novartis Investigative Site

City

St-Charles-Borromee

State/Province

Quebec

ZIP/Postal Code

J6E 2B4

Country

Canada

Facility Name

Novartis Investigative Site

City

Zipaquira

State/Province

Cundinamarca

ZIP/Postal Code

250252

Country

Colombia

Facility Name

Novartis Investigative Site

City

Liberec

State/Province

Czech Republic

ZIP/Postal Code

460 05

Country

Czechia

Facility Name

Novartis Investigative Site

City

Ostrava Poruba

State/Province

Czech Republic

ZIP/Postal Code

708 68

Country

Czechia

Facility Name

Novartis Investigative Site

City

Teplice

State/Province

Czech Republic

ZIP/Postal Code

415 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Varnsdorf

ZIP/Postal Code

40747

Country

Czechia

Facility Name

Novartis Investigative Site

City

Aalborg

ZIP/Postal Code

DK 9000

Country

Denmark

Facility Name

Novartis Investigative Site

City

Copenhagen

ZIP/Postal Code

DK-2400

Country

Denmark

Facility Name

Novartis Investigative Site

City

Hvidovre

ZIP/Postal Code

2650

Country

Denmark

Facility Name

Novartis Investigative Site

City

Montpellier cedex 5

State/Province

Herault

ZIP/Postal Code

34059

Country

France

Facility Name

Novartis Investigative Site

City

Lyon Cedex 04

ZIP/Postal Code

69317

Country

France

Facility Name

Novartis Investigative Site

City

Pessac Cedex

ZIP/Postal Code

33604

Country

France

Facility Name

Novartis Investigative Site

City

Reims

ZIP/Postal Code

51092

Country

France

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10119

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12157

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12159

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60596

Country

Germany

Facility Name

Novartis Investigative Site

City

Halle

ZIP/Postal Code

06108

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20354

Country

Germany

Facility Name

Novartis Investigative Site

City

Landsberg

ZIP/Postal Code

86899

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04207

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

D-04299

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

D-04347

Country

Germany

Facility Name

Novartis Investigative Site

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Novartis Investigative Site

City

Marburg

ZIP/Postal Code

35037

Country

Germany

Facility Name

Novartis Investigative Site

City

Mittweida

ZIP/Postal Code

09648

Country

Germany

Facility Name

Novartis Investigative Site

City

Witten

ZIP/Postal Code

58452

Country

Germany

Facility Name

Novartis Investigative Site

City

Thessaloniki

State/Province

ZIP/Postal Code

570 10

Country

Greece

Facility Name

Novartis Investigative Site

City

Heraklion Crete

ZIP/Postal Code

711 10

Country

Greece

Facility Name

Novartis Investigative Site

City

Guatemala City

State/Province

GTM

ZIP/Postal Code

01010

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Guatemala City

State/Province

GTM

ZIP/Postal Code

01011

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Guatemala City

ZIP/Postal Code

01011

Country

Guatemala

Facility Name

Novartis Investigative Site

City

New Territories

Country

Hong Kong

Facility Name

Novartis Investigative Site

City

Pokfulam

Country

Hong Kong

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1106

Country

Hungary

Facility Name

Novartis Investigative Site

City

Godollo

ZIP/Postal Code

2100

Country

Hungary

Facility Name

Novartis Investigative Site

City

Komarom

ZIP/Postal Code

2900

Country

Hungary

Facility Name

Novartis Investigative Site

City

Mako

ZIP/Postal Code

6900

Country

Hungary

Facility Name

Novartis Investigative Site

City

Pecs

ZIP/Postal Code

7635

Country

Hungary

Facility Name

Novartis Investigative Site

City

Genova

State/Province

ZIP/Postal Code

16132

Country

Italy

Facility Name

Novartis Investigative Site

City

Siena

State/Province

ZIP/Postal Code

53100

Country

Italy

Facility Name

Novartis Investigative Site

City

Negrar

State/Province

ZIP/Postal Code

37024

Country

Italy

Facility Name

Novartis Investigative Site

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

457 8510

Country

Japan

Facility Name

Novartis Investigative Site

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

457-8511

Country

Japan

Facility Name

Novartis Investigative Site

City

Fukuoka city

State/Province

Fukuoka

ZIP/Postal Code

811-1394

Country

Japan

Facility Name

Novartis Investigative Site

City

Fukuoka-city

State/Province

Fukuoka

ZIP/Postal Code

819-8555

Country

Japan

Facility Name

Novartis Investigative Site

City

Kasuga-city

State/Province

Fukuoka

ZIP/Postal Code

816-0813

Country

Japan

Facility Name

Novartis Investigative Site

City

Koga city

State/Province

Fukuoka

ZIP/Postal Code

811 3195

Country

Japan

Facility Name

Novartis Investigative Site

City

Yanagawa-city

State/Province

Fukuoka

ZIP/Postal Code

832-0059

Country

Japan

Facility Name

Novartis Investigative Site

City

Mizunami-city

State/Province

Gifu

ZIP/Postal Code

509 6134

Country

Japan

Facility Name

Novartis Investigative Site

City

Asahikawa-city

State/Province

Hokkaido

ZIP/Postal Code

070-8644

Country

Japan

Facility Name

Novartis Investigative Site

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

062-8618

Country

Japan

Facility Name

Novartis Investigative Site

City

Naka-gun

State/Province

Ibaraki

ZIP/Postal Code

319-1113

Country

Japan

Facility Name

Novartis Investigative Site

City

Kawasaki-city

State/Province

Kanagawa

ZIP/Postal Code

210-0852

Country

Japan

Facility Name

Novartis Investigative Site

City

Sagamihara-city

State/Province

Kanagawa

ZIP/Postal Code

252-0392

Country

Japan

Facility Name

Novartis Investigative Site

City

Yokohama-city

State/Province

Kanagawa

ZIP/Postal Code

223-0059

Country

Japan

Facility Name

Novartis Investigative Site

City

Matsusaka-city

State/Province

Mie

ZIP/Postal Code

515-8544

Country

Japan

Facility Name

Novartis Investigative Site

City

Sendai-shi

State/Province

Miyagi

ZIP/Postal Code

983 8520

Country

Japan

Facility Name

Novartis Investigative Site

City

Kawachinagano

State/Province

Osaka

ZIP/Postal Code

586-8521

Country

Japan

Facility Name

Novartis Investigative Site

City

Kishiwada-city

State/Province

Osaka

ZIP/Postal Code

596-8501

Country

Japan

Facility Name

Novartis Investigative Site

City

Toyonaka

State/Province

Osaka

ZIP/Postal Code

560-8552

Country

Japan

Facility Name

Novartis Investigative Site

City

Chuo ku

State/Province

Tokyo

ZIP/Postal Code

104-0031

Country

Japan

Facility Name

Novartis Investigative Site

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

103-0003

Country

Japan

Facility Name

Novartis Investigative Site

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

103-0028

Country

Japan

Facility Name

Novartis Investigative Site

City

Kodaira

State/Province

Tokyo

ZIP/Postal Code

187-0024

Country

Japan

Facility Name

Novartis Investigative Site

City

Setagaya-Ku

State/Province

Tokyo

ZIP/Postal Code

157-0072

Country

Japan

Facility Name

Novartis Investigative Site

City

Setagaya-ku

State/Province

Tokyo

ZIP/Postal Code

158-8531

Country

Japan

Facility Name

Novartis Investigative Site

City

Shinagawa

State/Province

Tokyo

ZIP/Postal Code

140-8522

Country

Japan

Facility Name

Novartis Investigative Site

City

Toshima ku

State/Province

Tokyo

ZIP/Postal Code

170 0003

Country

Japan

Facility Name

Novartis Investigative Site

City

Yamagata city

State/Province

Yamagata

ZIP/Postal Code

990-8533

Country

Japan

Facility Name

Novartis Investigative Site

City

Osaka

ZIP/Postal Code

531-0073

Country

Japan

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Seocho Gu

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Daegu

ZIP/Postal Code

705703

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Incheon

ZIP/Postal Code

21431

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Eindhoven

ZIP/Postal Code

5623 EJ

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Harderwijk

ZIP/Postal Code

3840 AC

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Lipa City

State/Province

Batangas

ZIP/Postal Code

4217

Country

Philippines

Facility Name

Novartis Investigative Site

City

Iloilo city

State/Province

Iloilo

ZIP/Postal Code

5000

Country

Philippines

Facility Name

Novartis Investigative Site

City

Bulacan

ZIP/Postal Code

3020

Country

Philippines

Facility Name

Novartis Investigative Site

City

Iloilo City

ZIP/Postal Code

5000

Country

Philippines

Facility Name

Novartis Investigative Site

City

Manila

ZIP/Postal Code

1000

Country

Philippines

Facility Name

Novartis Investigative Site

City

Grudziadz

ZIP/Postal Code

86-300

Country

Poland

Facility Name

Novartis Investigative Site

City

Katowice

ZIP/Postal Code

40-648

Country

Poland

Facility Name

Novartis Investigative Site

City

Zawadzkie

ZIP/Postal Code

47-120

Country

Poland

Facility Name

Novartis Investigative Site

City

Bardejov

State/Province

Slovak Republic

ZIP/Postal Code

085 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bojnice

State/Province

Slovak Republic

ZIP/Postal Code

972 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Humenne

State/Province

Slovak Republic

ZIP/Postal Code

066 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Poprad

ZIP/Postal Code

058 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Presov

ZIP/Postal Code

080 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Spisska Nova Ves

ZIP/Postal Code

052 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Vysne Hagy

ZIP/Postal Code

5984

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Marbella

State/Province

Andalucia

ZIP/Postal Code

29603

Country

Spain

Facility Name

Novartis Investigative Site

City

Alzira

State/Province

Comunidad Valenciana

ZIP/Postal Code

46600

Country

Spain

Facility Name

Novartis Investigative Site

City

Girona

ZIP/Postal Code

17005

Country

Spain

Facility Name

Novartis Investigative Site

City

Songkhla

State/Province

Hat Yai

ZIP/Postal Code

90110

Country

Thailand

Facility Name

Novartis Investigative Site

City

Khon Kaen

State/Province

THA

ZIP/Postal Code

40002

Country

Thailand

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Novartis Investigative Site

City

Adana

ZIP/Postal Code

01330

Country

Turkey

Facility Name

Novartis Investigative Site

City

Mersin

ZIP/Postal Code

33079

Country

Turkey

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

EC1A 7BE

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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

Learn more about this trial

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

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

Pulmonary Disease, Chronic Obstructive

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial