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Study to Compare QVM149 and Free Triple Combination of Salmeterol/Fluticasone + Tiotropium (ARGON)

Primary Purpose

Asthma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

QVM149

Salmeterol/fluticasone plus tiotropium

About this trial

This is an interventional treatment trial for Asthma focused on measuring QVM149, Asthma, Moderate Asthma, Severe Asthma, ICS/LABA/LAMA, ICS/LABA, LAMA, Adult

Eligibility Criteria

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

Inclusion Criteria:

Patients with a diagnosis of asthma for a period of at least 6 months prior to Visit 1 with current asthma severity ≥ step 4 (GINA 2017).
Patients who had used ICS/LABA combinations for asthma for at least 3 months and at stable medium or high dose of ICS/LABA for at least 1 month prior to Visit 1.
Patients were required to be symptomatic at screening despite treatment with medium or high stable doses of ICS/LABA as defined by ACQ-7 score ≥ 1.5 at visits 101 and 201 (randomization visit).
Patients with history of at least one severe asthma exacerbation which required medical care from a physician, emergency room visit (or local equivalent structure) or hospitalization in the 12 months prior to Visit 1 and required systemic corticosteroid treatment for at least 3 days including physician guided self-management treatment with oral corticosteroids as part of written asthma action plan.
Pre-bronchodilator FEV1 of < 85 % of the predicted normal value for the patient after withholding bronchodilators prior to spirometry at both Visit 101 and Visit 201.
Patients who demonstrated an increase in FEV1 of ≥ 12% and 200 ml.

Exclusion Criteria:

Patients who had a smoking history of greater than 20 pack years.
Patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD).
Patients who had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 6 weeks of Visit 1 (Screening).
Patients treated with a LAMA for asthma within 3 months prior to Visit 1.
Patients who had a respiratory tract infection or clinical significant asthma worsening as defined by Investigator within 4 weeks prior to Visit 1 or between Visit 1 and Visit 201.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

QVM149 150/50/80 μg

QVM149 150/50/160 μg

Salmeterol/fluticasone 50/500 μg plus tiotropium 5 μg

Arm Description

QVM149 150/50/80 μg o.d. delivered via Concept1

QVM149 150/50/160 μg o.d. delivered via Concept1

Salmeterol/fluticasone 50/500 μg b.i.d. delivered via Accuhaler® plus tiotropium 5 μg o.d. delivered via Respimat®

Outcomes

Primary Outcome Measures

Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total Score

The AQLQ is a 32-item asthma specific questionnaire designed to measure functional impairments that are most important to patients with asthma, with a recall time of two weeks and each question to be answered on a 7-point scale, where 1=totally limited/problems all the time and 7= not at all limited/no problems. It consists of 4 domains: symptoms, activity limitation, emotional funtion, and emotional stimuli. The overall score is calculated as the mean of 32 items. Higher AQLQ scores indicate better health-related quality of life.

Secondary Outcome Measures

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1)

FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. Trough FEV1 is the mean of two FEV1 values measures taken 15 minutes (min) and 45 min prior to evening dose.

Change From Baseline in Asthma Control Questionnaire (ACQ-7) Total Score

The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue medication use and 1 on airway calibre (FEV1 % predicted). All seven items are scored on a 7-point Likert scale, with 0 indicating total control and 6 indicating poor control. The questions are equally weighted and the total score is the mean of the seven items. Higher score indicates worst symptoms. The first 6 questions of the ACQ-7 were completed by the participant while the last question was completed by the study investigator using data from the Master Scope spirometer. A negative change from baseline indicates improvement in lung function.

Change From Baseline in AQLQ Total Score

The AQLQ is a 32-item asthma specific questionnaire designed to measure functional impairments that are most important to patients with asthma, with a recall time of two weeks and each question to be answered on a 7-point scale, where 1=totally limited/problems all the time and 7= not at all limited/no problems. It consists of 4 domains: symptoms, activity limitation, emotional function and environmental stimuli. The overall score is calculated as the mean of 32 items. Higher AQLQ scores indicate better health-related quality of life.

Percentage of Patients Achieving the Minimally Clinically Important Difference (MCID) Decrease From Baseline ACQ-7 ≥ 0.5

Percentage of Patients Achieving the Minimally Clinically Important Difference (MCID) Change From Baseline AQLQ ≥ 0.5

The AQLQ is a 32-item asthma specific questionnaire designed to measure functional impairments that are most important to patients with asthma, with a recall time of two weeks and each question to be answered on a 7-point scale, where 1=totally limited/problems all the time and 7= not at all limited/no problems. It consists of 4 domains: symptoms, activity limitation, emotional function and environmental stimuli. The overall score is calculated as the mean of 32 items. Higher AQLQ scores indicate better health-related quality of life. An improvement of 0.5 points in AQLQ score is considered to be the minimally clinically important difference in asthma.

Change From Baseline in Forced Vital Capacity (FVC)

FVC is the total volume of air exhaled during a expiratory maneuvre. It was assessed by performing a spirometry assessment.

Change From Baseline in Forced Expiratory Flow Between 25% and 75% of Forced Vital Capacity (FEF25-75)

Forced expiratory flow during the mid (25 - 75%) portion of the FVC. It was assessed by performing spirometric assessment.

Full Information

NCT ID

NCT03158311

First Posted

May 16, 2017

Last Updated

October 7, 2021

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03158311

Brief Title

Study to Compare QVM149 and Free Triple Combination of Salmeterol/Fluticasone + Tiotropium

Acronym

ARGON

Official Title

A Multicenter, Partially-Blinded, Randomized, 24-Week, Parallel-Group, Non-Inferiority, Open-Label Active Controlled Study to Compare the Efficacy and Safety of QVM149 With a Free Triple Combination of Salmeterol/Fluticasone + Tiotropium in Patients With Uncontrolled Asthma

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

February 5, 2018 (Actual)

Primary Completion Date

July 12, 2019 (Actual)

Study Completion Date

July 19, 2019 (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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this trial was to demonstrate that the efficacy of two treatment arms of the fixed-dose combination product QVM149 was non-inferior to the efficacy of the free combination arm of salmeterol/ fluticasone+ tiotropium in uncontrolled moderate to severe asthmatic patients. The planned duration of treatment in this study was 24 weeks, followed up by a 7-day follow-up period.

Detailed Description

This study used a randomized, partially-blinded, 24-week, parallel-group, non-inferiority, open-label active controlled design. The study was partially open-label. Investigators and patients had knowledge of treatment allocation between QVM149 and/or comparator, however the QVM149 strength allocation was masked. The global sponsor team responsible for data review and analysis was blinded to all treatment allocations The study consisted of a screening period of up to 1-week, run-in period of 2-weeks, randomized treatment period of 24-weeks, and a follow-up period of 1-week. At the screening visit, informed consent was obtained, and current and prohibited medications were reviewed. Rescue medication was provided to all patients who met the eligibility criteria and was to be used on an "as needed" basis throughout the study. At the run-in visit, inclusion and exclusion criteria were reviewed and the patients were supplied with open-label long acting β2-adrenergic agonist/inhaled corticosteroids (LABA/ICS) salmeterol/fluticasone 50/250 μg b.i.d or 50/500 μg b.i.d to match their ICS background medication dose to be stopped at randomization visit. All patients who met the eligibility criteria were randomized to 1 of 3 treatment arms with a randomization ratio of 1:1:1. The patients were stratified at randomization according to the ICS dose component of background ICS/LABA (medium or high dose) and region. Treatment period visits were scheduled every 8 weeks. The study used two doses of QVM149 (high dose [150/50/160 μg] and a medium dose [150/50/80 μg] o.d. delivered via Concept1 inhaler) and a comparator treatment (salmeterol/fluticasone 50/500 μg b.i.d. delivered via Accuhaler® plus tiotropium 5 μg o.d delivered via Respimat®). All randomized patients were contacted (by telephone) 7 days following the last dose of study medication or last visit, whichever was later, for Safety Follow-up visit.

6. Conditions and Keywords

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

Asthma

Keywords

QVM149, Asthma, Moderate Asthma, Severe Asthma, ICS/LABA/LAMA, ICS/LABA, LAMA, Adult

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

The free triple combination of salmeterol/fluticasone + tiotropium was open label, for which investigators and patients had full knowledge that the patient had been assigned free triple combination comparator treatment. Within the two QVM149 treatment arms patients, investigator staff, and persons performing the assessments, remained blind to the identity of the actual QVM149 treatment dose but had full knowledge that the patient had been assigned QVM149 as study treatment. The data analysts and sponsor team were blinded to Case Report Forms that reveal the treatment arm. Randomization data and treatment codes were kept strictly confidential until the time of unblinding, and was not accessible by anyone else involved in the study.

Allocation

Randomized

Enrollment

1426 (Actual)

8. Arms, Groups, and Interventions

Arm Title

QVM149 150/50/80 μg

Arm Type

Experimental

Arm Description

QVM149 150/50/80 μg o.d. delivered via Concept1

Arm Title

QVM149 150/50/160 μg

Arm Type

Experimental

Arm Description

QVM149 150/50/160 μg o.d. delivered via Concept1

Arm Title

Salmeterol/fluticasone 50/500 μg plus tiotropium 5 μg

Arm Type

Active Comparator

Arm Description

Salmeterol/fluticasone 50/500 μg b.i.d. delivered via Accuhaler® plus tiotropium 5 μg o.d. delivered via Respimat®

Intervention Type

Drug

Intervention Name(s)

QVM149

Intervention Description

Indacaterol acetate / glycopyrronium bromide / mometasone furoate

Intervention Type

Drug

Intervention Name(s)

Salmeterol/fluticasone plus tiotropium

Intervention Description

Free triple arm of salmeterol / fluticasone plus tiotropium

Primary Outcome Measure Information:

Title

Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total Score

Description

Time Frame

Baseline and Week 24

Secondary Outcome Measure Information:

Title

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1)

Description

Time Frame

Baseline, Week 8, Week 16 and Week 24

Title

Change From Baseline in Asthma Control Questionnaire (ACQ-7) Total Score

Description

Time Frame

Baseline, Week 16 and Week 24

Title

Change From Baseline in AQLQ Total Score

Description

The AQLQ is a 32-item asthma specific questionnaire designed to measure functional impairments that are most important to patients with asthma, with a recall time of two weeks and each question to be answered on a 7-point scale, where 1=totally limited/problems all the time and 7= not at all limited/no problems. It consists of 4 domains: symptoms, activity limitation, emotional function and environmental stimuli. The overall score is calculated as the mean of 32 items. Higher AQLQ scores indicate better health-related quality of life.

Time Frame

Baseline and Week 16

Title

Percentage of Patients Achieving the Minimally Clinically Important Difference (MCID) Decrease From Baseline ACQ-7 ≥ 0.5

Description

Time Frame

Baseline and Week 24

Title

Percentage of Patients Achieving the Minimally Clinically Important Difference (MCID) Change From Baseline AQLQ ≥ 0.5

Description

The AQLQ is a 32-item asthma specific questionnaire designed to measure functional impairments that are most important to patients with asthma, with a recall time of two weeks and each question to be answered on a 7-point scale, where 1=totally limited/problems all the time and 7= not at all limited/no problems. It consists of 4 domains: symptoms, activity limitation, emotional function and environmental stimuli. The overall score is calculated as the mean of 32 items. Higher AQLQ scores indicate better health-related quality of life. An improvement of 0.5 points in AQLQ score is considered to be the minimally clinically important difference in asthma.

Time Frame

Baseline and Week 24

Title

Change From Baseline in Forced Vital Capacity (FVC)

Description

FVC is the total volume of air exhaled during a expiratory maneuvre. It was assessed by performing a spirometry assessment.

Time Frame

Baseline, Week 8, Week 16 and Week 24

Title

Change From Baseline in Forced Expiratory Flow Between 25% and 75% of Forced Vital Capacity (FEF25-75)

Description

Forced expiratory flow during the mid (25 - 75%) portion of the FVC. It was assessed by performing spirometric assessment.

Time Frame

Baseline, Week 8, Week 16 and Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with a diagnosis of asthma for a period of at least 6 months prior to Visit 1 with current asthma severity ≥ step 4 (GINA 2017). Patients who had used ICS/LABA combinations for asthma for at least 3 months and at stable medium or high dose of ICS/LABA for at least 1 month prior to Visit 1. Patients were required to be symptomatic at screening despite treatment with medium or high stable doses of ICS/LABA as defined by ACQ-7 score ≥ 1.5 at visits 101 and 201 (randomization visit). Patients with history of at least one severe asthma exacerbation which required medical care from a physician, emergency room visit (or local equivalent structure) or hospitalization in the 12 months prior to Visit 1 and required systemic corticosteroid treatment for at least 3 days including physician guided self-management treatment with oral corticosteroids as part of written asthma action plan. Pre-bronchodilator FEV1 of < 85 % of the predicted normal value for the patient after withholding bronchodilators prior to spirometry at both Visit 101 and Visit 201. Patients who demonstrated an increase in FEV1 of ≥ 12% and 200 ml. Exclusion Criteria: Patients who had a smoking history of greater than 20 pack years. Patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD). Patients who had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 6 weeks of Visit 1 (Screening). Patients treated with a LAMA for asthma within 3 months prior to Visit 1. Patients who had a respiratory tract infection or clinical significant asthma worsening as defined by Investigator within 4 weeks prior to Visit 1 or between Visit 1 and Visit 201.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Berazategui

State/Province

Buenos Aires

ZIP/Postal Code

1888

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1122AAK

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1280AEB

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1414AIF

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1424BSF

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1425BEN

Country

Argentina

Facility Name

Novartis Investigative Site

City

Florida

State/Province

Buenos Aires

ZIP/Postal Code

B1602DQD

Country

Argentina

Facility Name

Novartis Investigative Site

City

Lanus

State/Province

Buenos Aires

ZIP/Postal Code

B8000XAV

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

Nueve de Julio

State/Province

Buenos Aires

ZIP/Postal Code

B6500EZL

Country

Argentina

Facility Name

Novartis Investigative Site

City

Ranelagh, Partido De Berazate

State/Province

Buenos Aires

ZIP/Postal Code

1884

Country

Argentina

Facility Name

Novartis Investigative Site

City

Concepcion del Uruguay

State/Province

Entre Rios

ZIP/Postal Code

3260

Country

Argentina

Facility Name

Novartis Investigative Site

City

Santa Rosa

State/Province

La Pampa

ZIP/Postal Code

6300

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

State/Province

Nueve De Julio

ZIP/Postal Code

B6500BWQ

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

S2000BRH

Country

Argentina

Facility Name

Novartis Investigative Site

City

San Miguel de Tucuman

State/Province

Tucuman

ZIP/Postal Code

4000

Country

Argentina

Facility Name

Novartis Investigative Site

City

Bahia Blanca

ZIP/Postal Code

B8000JRB

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

1900

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

B1646EBJ

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1125ABE

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1425FVH

Country

Argentina

Facility Name

Novartis Investigative Site

City

Ciudad Autonoma de Bs As

ZIP/Postal Code

C1128AAF

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

5501

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

4400

Country

Argentina

Facility Name

Novartis Investigative Site

City

Santa Fe

ZIP/Postal Code

S3000FIL

Country

Argentina

Facility Name

Novartis Investigative Site

City

Santiago

State/Province

Region Metropolitana

ZIP/Postal Code

7500692

Country

Chile

Facility Name

Novartis Investigative Site

City

Curico

State/Province

VII Region Del Maule

ZIP/Postal Code

3341643

Country

Chile

Facility Name

Novartis Investigative Site

City

Bogota

State/Province

Cundinamarca

ZIP/Postal Code

110911

Country

Colombia

Facility Name

Novartis Investigative Site

City

Bogota

ZIP/Postal Code

110221

Country

Colombia

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

Prague

State/Province

Czech Republic

ZIP/Postal Code

169 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Teplice

State/Province

CZE

ZIP/Postal Code

415 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Lovosice

ZIP/Postal Code

41002

Country

Czechia

Facility Name

Novartis Investigative Site

City

Miroslav

ZIP/Postal Code

67172

Country

Czechia

Facility Name

Novartis Investigative Site

City

Peine

State/Province

Niedersachsen

ZIP/Postal Code

31224

Country

Germany

Facility Name

Novartis Investigative Site

City

Geesthacht

State/Province

Schleswig Holstein

ZIP/Postal Code

12502

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10119

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10625

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10717

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10969

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

Berlin

ZIP/Postal Code

12203

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13086

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13156

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13187

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

14050

Country

Germany

Facility Name

Novartis Investigative Site

City

Boehlen

ZIP/Postal Code

04564

Country

Germany

Facility Name

Novartis Investigative Site

City

Bonn

ZIP/Postal Code

53123

Country

Germany

Facility Name

Novartis Investigative Site

City

Darmstadt

ZIP/Postal Code

64283

Country

Germany

Facility Name

Novartis Investigative Site

City

Dortmund

ZIP/Postal Code

44263

Country

Germany

Facility Name

Novartis Investigative Site

City

Einbeck

ZIP/Postal Code

37574

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60389

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60596

Country

Germany

Facility Name

Novartis Investigative Site

City

Furstenwalde

ZIP/Postal Code

15517

Country

Germany

Facility Name

Novartis Investigative Site

City

Gelsenkirchen

ZIP/Postal Code

45879

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20354

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22335

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30167

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30173

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04157

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04275

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04357

Country

Germany

Facility Name

Novartis Investigative Site

City

Lubeck

ZIP/Postal Code

23552

Country

Germany

Facility Name

Novartis Investigative Site

City

Ludwigsburg

ZIP/Postal Code

71640

Country

Germany

Facility Name

Novartis Investigative Site

City

Marburg

ZIP/Postal Code

35037

Country

Germany

Facility Name

Novartis Investigative Site

City

Marburg

ZIP/Postal Code

D-35037

Country

Germany

Facility Name

Novartis Investigative Site

City

Menden

ZIP/Postal Code

58706

Country

Germany

Facility Name

Novartis Investigative Site

City

Mittweida

ZIP/Postal Code

09648

Country

Germany

Facility Name

Novartis Investigative Site

City

Munchen

ZIP/Postal Code

81241

Country

Germany

Facility Name

Novartis Investigative Site

City

Potsdam

ZIP/Postal Code

14467

Country

Germany

Facility Name

Novartis Investigative Site

City

Rudersdorf

ZIP/Postal Code

15562

Country

Germany

Facility Name

Novartis Investigative Site

City

Schleswig

ZIP/Postal Code

24837

Country

Germany

Facility Name

Novartis Investigative Site

City

Witten

ZIP/Postal Code

58452

Country

Germany

Facility Name

Novartis Investigative Site

City

Athens

State/Province

ZIP/Postal Code

115 27

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

State/Province

ZIP/Postal Code

546 03

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

State/Province

ZIP/Postal Code

564 29

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

State/Province

ZIP/Postal Code

570 10

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

12462

Country

Greece

Facility Name

Novartis Investigative Site

City

Puspokladany

State/Province

HUN

ZIP/Postal Code

4150

Country

Hungary

Facility Name

Novartis Investigative Site

City

Balassagyarmat

ZIP/Postal Code

2660

Country

Hungary

Facility Name

Novartis Investigative Site

City

Godollo

ZIP/Postal Code

2100

Country

Hungary

Facility Name

Novartis Investigative Site

City

Komlo

ZIP/Postal Code

7300

Country

Hungary

Facility Name

Novartis Investigative Site

City

Sellye

ZIP/Postal Code

7960

Country

Hungary

Facility Name

Novartis Investigative Site

City

Siofok

ZIP/Postal Code

8600

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szarvas

ZIP/Postal Code

5540

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szeged

ZIP/Postal Code

6722

Country

Hungary

Facility Name

Novartis Investigative Site

City

Vijayawada

State/Province

Andhra Pradesh

ZIP/Postal Code

520008

Country

India

Facility Name

Novartis Investigative Site

City

Kozhikode

State/Province

Kerala

ZIP/Postal Code

673008

Country

India

Facility Name

Novartis Investigative Site

City

Nagpur

State/Province

Maharashtra

ZIP/Postal Code

440019

Country

India

Facility Name

Novartis Investigative Site

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411014

Country

India

Facility Name

Novartis Investigative Site

City

Mohali

State/Province

Punjab

ZIP/Postal Code

160 062

Country

India

Facility Name

Novartis Investigative Site

City

Coimbatore

State/Province

Tamil Nadu

ZIP/Postal Code

641 045

Country

India

Facility Name

Novartis Investigative Site

City

Vellore

State/Province

Tamil Nadu

ZIP/Postal Code

632004

Country

India

Facility Name

Novartis Investigative Site

City

Hyderabad

State/Province

Telangana

ZIP/Postal Code

500 038

Country

India

Facility Name

Novartis Investigative Site

City

Kolkata

State/Province

West Bengal

ZIP/Postal Code

700 107

Country

India

Facility Name

Novartis Investigative Site

City

Jerusalem

ZIP/Postal Code

91031

Country

Israel

Facility Name

Novartis Investigative Site

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Novartis Investigative Site

City

Ramat Gan

ZIP/Postal Code

5266202

Country

Israel

Facility Name

Novartis Investigative Site

City

Rehovot

ZIP/Postal Code

76100

Country

Israel

Facility Name

Novartis Investigative Site

City

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

14050

Country

Mexico

Facility Name

Novartis Investigative Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44100

Country

Mexico

Facility Name

Novartis Investigative Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44160

Country

Mexico

Facility Name

Novartis Investigative Site

City

San Martin de Porres

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

Santiago de Surco

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

Cusco

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

Katowice

ZIP/Postal Code

40-648

Country

Poland

Facility Name

Novartis Investigative Site

City

Poznan

ZIP/Postal Code

60 823

Country

Poland

Facility Name

Novartis Investigative Site

City

Poznan

ZIP/Postal Code

60-214

Country

Poland

Facility Name

Novartis Investigative Site

City

Poznan

ZIP/Postal Code

60-693

Country

Poland

Facility Name

Novartis Investigative Site

City

Izhevsk

ZIP/Postal Code

426061

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Kemerovo

ZIP/Postal Code

650002

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

105275

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

109544

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

123423

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Nizhny Novgorod

ZIP/Postal Code

603018

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Novosibirsk

ZIP/Postal Code

630102

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint Petersburg

ZIP/Postal Code

107022

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint Petersburg

ZIP/Postal Code

195271

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint-Petersburg

ZIP/Postal Code

191186

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint-Petersburg

ZIP/Postal Code

196143

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saratov

ZIP/Postal Code

410028

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saratov

ZIP/Postal Code

410054

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St Petersburg

ZIP/Postal Code

193312

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Ulyanovsk

ZIP/Postal Code

432063

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Yekaterinburg

ZIP/Postal Code

620109

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Novartis Investigative Site

City

Kragujevac

ZIP/Postal Code

34000

Country

Serbia

Facility Name

Novartis Investigative Site

City

Nis

ZIP/Postal Code

18000

Country

Serbia

Facility Name

Novartis Investigative Site

City

Sremska Kamenica

ZIP/Postal Code

21204

Country

Serbia

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

Liptovsky Hradok

State/Province

Slovak Republic

ZIP/Postal Code

033 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Liptovsky Mikulas

ZIP/Postal Code

031 23

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Topolcany

ZIP/Postal Code

95501

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Zilina

ZIP/Postal Code

01001

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Berea

State/Province

Durban

ZIP/Postal Code

4001

Country

South Africa

Facility Name

Novartis Investigative Site

City

Cape Town

ZIP/Postal Code

7530

Country

South Africa

Facility Name

Novartis Investigative Site

City

Cape Town

ZIP/Postal Code

7700

Country

South Africa

Facility Name

Novartis Investigative Site

City

Chatsworth

ZIP/Postal Code

4092

Country

South Africa

Facility Name

Novartis Investigative Site

City

Kempton Park

ZIP/Postal Code

1619

Country

South Africa

Facility Name

Novartis Investigative Site

City

Pretoria

ZIP/Postal Code

0183

Country

South Africa

Facility Name

Novartis Investigative Site

City

Esparraguera

State/Province

Barcelona

ZIP/Postal Code

08292

Country

Spain

Facility Name

Novartis Investigative Site

City

Hostalets De Balenya

State/Province

Cataluna

ZIP/Postal Code

08550

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

Caceres

State/Province

Extremadura

ZIP/Postal Code

10003

Country

Spain

Facility Name

Novartis Investigative Site

City

Benalmadena

State/Province

Malaga

ZIP/Postal Code

29639

Country

Spain

Facility Name

Novartis Investigative Site

City

Kaoshiung

ZIP/Postal Code

80756

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

10449

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Izmir

ZIP/Postal Code

35040

Country

Turkey

Facility Name

Novartis Investigative Site

City

Mersin

ZIP/Postal Code

33343

Country

Turkey

Facility Name

Novartis Investigative Site

City

Yenisehir/Izmir

ZIP/Postal Code

35110

Country

Turkey

Facility Name

Novartis Investigative Site

City

Ho Chi Minh

State/Province

VNM

ZIP/Postal Code

700000

Country

Vietnam

Facility Name

Novartis Investigative Site

City

Hanoi

ZIP/Postal Code

100000

Country

Vietnam

Facility Name

Novartis Investigative Site

City

Ho Chi Minh

ZIP/Postal Code

700000

Country

Vietnam

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=657

Description

A Plain Language Trial Summary is available on novartisclinicaltrials.com

Learn more about this trial

Study to Compare QVM149 and Free Triple Combination of Salmeterol/Fluticasone + Tiotropium

We'll reach out to this number within 24 hrs

Study to Compare QVM149 and Free Triple Combination of Salmeterol/Fluticasone + Tiotropium (ARGON)

Asthma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

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