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

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03158311
Recruitment Status : Completed
First Posted : May 18, 2017
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The purpose of this trial is to demonstrate that the efficacy of two treatment arms of the fixed-dose combination product QVM149 is non-inferior to the efficacy of the free combination arm of salmeterol/ fluticasone+ tiotropium in uncontrolled asthmatics.

Condition or disease Intervention/treatment Phase
Asthma Drug: QVM149 Drug: Salmeterol/fluticasone plus tiotropium Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1436 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The free triple combination of salmeterol/fluticasone + tiotropium is open label for which investigators and patients will have full knowledge the patient has been assigned free triple combination comparator treatment. Within the two QVM149 treatment arms patients, investigator staff, and persons performing the assessments, will remain blind to the identity of the actual QVM149 treatment dose but will have full knowledge that the patient has been assigned QVM149 as study treatment. The data analysts and sponsor team will be blinded to Case Report Forms that reveal the treatment arm. Randomization data and treatment codes are kept strictly confidential until the time of unblinding, and will not be accessible by anyone else involved in the study.
Primary Purpose: Treatment
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
Actual Study Start Date : February 5, 2018
Actual Primary Completion Date : July 12, 2019
Actual Study Completion Date : July 19, 2019


Arm Intervention/treatment
Experimental: QVM149 arm 1
QVM149 150/50/80 μg o.d. delivered via Concept1
Drug: QVM149
Indacaterol acetate / Glycopyrronium bromide / Mometasone furoate

Experimental: QVM149 arm 2
QVM149 150/50/160 μg o.d. delivered via Concept1
Drug: QVM149
Indacaterol acetate / Glycopyrronium bromide / Mometasone furoate

Active Comparator: Salmeterol/fluticasone plus tiotropium arm
Salmeterol/fluticasone 50/500 μg b.i.d. delivered via Accuhaler® plus tiotropium 5 μg o.d. delivered via Respimat®
Drug: Salmeterol/fluticasone plus tiotropium
free triple arm of Salmeterol/fluticasone plus tiotropium




Primary Outcome Measures :
  1. Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) total score [ Time Frame: 24 weeks ]
    The AQLQ is a 32-item asthma specific questionnaire designed to measure functional impairments that are most important to patients with asthma.


Secondary Outcome Measures :
  1. Change from baseline in Trough FEV1 [ Time Frame: 8 weeks, 16 weeks, 24 weeks ]
    Forced Expiratory Volume in 1 second (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.

  2. Change from baseline in Asthma Control Questionnaire (ACQ-7) total score [ Time Frame: 16 weeks, 24 weeks ]
    ACQ is the Asthma Control Questionnaire (scoring 5 symptoms, FEV1 entered by the investigator and the rescue medication use entered by the patient) validated to evaluate different levels of asthma control

  3. Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) total score [ Time Frame: 16 weeks ]
    The AQLQ is a 32-item asthma specific questionnaire designed to measure functional impairments that are most important to patients with asthma.

  4. Percentage of patients achieving the minimal important difference (MCID) change from baseline ACQ-7 ≥ 0.5 decrease [ Time Frame: 16 weeks, 24 weeks ]
    Responder rate; MCID for ACQ-7 is 0.5 decrease.

  5. Percentage of patients achieving the minimal important difference (MCID) change from baseline AQLQ ≥ 0.5 increase [ Time Frame: 16 weeks, 24 weeks ]
    Responder rate; MCID for AQLQ is 0.5 increase.

  6. Change from baseline in Forced Vital Capacity (FVC) [ Time Frame: 8 weeks, 16 weeks, 24 weeks ]
    FVC is the total amount of air exhaled during the FEV test.

  7. Change from baseline in Forced Expiratory Flow between 25% and 75% of Forced Vital Capacity (FEF25-75) [ Time Frame: 8 weeks, 16 weeks, 24 weeks ]
    Forced expiratory flow during the mid (25 - 75%) portion of the FVC.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 have 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 must 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 (see section 6.4.5) which required medical care from a physician, ER 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 demonstrate an increase in FEV1 of ≥ 12% and 200 mL.

Exclusion Criteria:

  • Patients who have a smoking history of greater than 20 pack years.
  • Patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD).
  • Patients who have 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 have 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03158311


Locations
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Argentina
Novartis Investigative Site
Berazategui, Buenos Aires, Argentina, 1888
Novartis Investigative Site
Caba, Buenos Aires, Argentina, C1122AAK
Novartis Investigative Site
Caba, Buenos Aires, Argentina, C1280AEB
Novartis Investigative Site
Caba, Buenos Aires, Argentina, C1414AIF
Novartis Investigative Site
Caba, Buenos Aires, Argentina, C1424BSF
Novartis Investigative Site
Caba, Buenos Aires, Argentina, C1425BEN
Novartis Investigative Site
Florida, Buenos Aires, Argentina, B1602DQD
Novartis Investigative Site
Lanus, Buenos Aires, Argentina, B8000XAV
Novartis Investigative Site
Mar del Plata, Buenos Aires, Argentina, 7600
Novartis Investigative Site
Ranelagh, Partido De Berazate, Buenos Aires, Argentina, 1884
Novartis Investigative Site
Concepcion del Uruguay, Entre Rios, Argentina, 3260
Novartis Investigative Site
Santa Rosa, La Pampa, Argentina, 6300
Novartis Investigative Site
Buenos Aires, Nueve De Julio, Argentina, B6500BWQ
Novartis Investigative Site
Rosario, Santa Fe, Argentina, S2000AII
Novartis Investigative Site
Rosario, Santa Fe, Argentina, S2000BRH
Novartis Investigative Site
San Miguel de Tucuman, Tucuman, Argentina, 4000
Novartis Investigative Site
Bahia Blanca, Argentina, B8000JRB
Novartis Investigative Site
Buenos Aires, Argentina, 1900
Novartis Investigative Site
Buenos Aires, Argentina, B1646EBJ
Novartis Investigative Site
Buenos Aires, Argentina, C1125ABE
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Buenos Aires, Argentina, C1425FVH
Novartis Investigative Site
Ciudad Autonoma de Bs As, Argentina, C1128AAF
Novartis Investigative Site
Mendoza, Argentina, 5500
Novartis Investigative Site
Mendoza, Argentina, M5500AAJ
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Mendoza, Argentina, M5500CBA
Novartis Investigative Site
Salta, Argentina, 4400
Novartis Investigative Site
Santa Fe, Argentina, S3000FIL
Chile
Novartis Investigative Site
Santiago, Region Metropolitana, Chile, 7500692
Novartis Investigative Site
Curico, VII Region Del Maule, Chile, 3341643
Colombia
Novartis Investigative Site
Bogota, Cundinamarca, Colombia, 110911
Novartis Investigative Site
Bogota DC, Colombia, 110221
Novartis Investigative Site
Bogota, Colombia, 110111
Czechia
Novartis Investigative Site
Ostrava Poruba, Czech Republic, Czechia, 708 68
Novartis Investigative Site
Prague, Czech Republic, Czechia, 169 00
Novartis Investigative Site
Teplice, CZE, Czechia, 415 01
Novartis Investigative Site
Lovosice, Czechia, 41002
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Miroslav, Czechia, 67172
Germany
Novartis Investigative Site
Peine, Niedersachsen, Germany, 31224
Novartis Investigative Site
Ibbenbueren, Rheinland Pfalz, Germany, 49477
Novartis Investigative Site
Geesthacht, Schleswig Holstein, Germany, 12502
Novartis Investigative Site
Annaberg-Buchholz, Germany, 09456
Novartis Investigative Site
Arnsberg, Germany, 59755
Novartis Investigative Site
Augsburg, Germany, 86150
Novartis Investigative Site
Bamberg, Germany, 96049
Novartis Investigative Site
Berlin, Germany, 10119
Novartis Investigative Site
Berlin, Germany, 10625
Novartis Investigative Site
Berlin, Germany, 10717
Novartis Investigative Site
Berlin, Germany, 10969
Novartis Investigative Site
Berlin, Germany, 12157
Novartis Investigative Site
Berlin, Germany, 12159
Novartis Investigative Site
Berlin, Germany, 12203
Novartis Investigative Site
Berlin, Germany, 13086
Novartis Investigative Site
Berlin, Germany, 13156
Novartis Investigative Site
Berlin, Germany, 13187
Novartis Investigative Site
Berlin, Germany, 14050
Novartis Investigative Site
Boehlen, Germany, 04564
Novartis Investigative Site
Bonn, Germany, 53123
Novartis Investigative Site
Dachau, Germany, 85221
Novartis Investigative Site
Darmstadt, Germany, 64283
Novartis Investigative Site
Dortmund, Germany, 44263
Novartis Investigative Site
Einbeck, Germany, 37574
Novartis Investigative Site
Frankfurt, Germany, 60389
Novartis Investigative Site
Frankfurt, Germany, 60596
Novartis Investigative Site
Furstenwalde, Germany, 15517
Novartis Investigative Site
Gelsenkirchen, Germany, 45879
Novartis Investigative Site
Gifhorn, Germany, 38518
Novartis Investigative Site
Hamburg, Germany, 20354
Novartis Investigative Site
Hamburg, Germany, 22335
Novartis Investigative Site
Hannover, Germany, 30167
Novartis Investigative Site
Hannover, Germany, 30173
Novartis Investigative Site
Leipzig, Germany, 04103
Novartis Investigative Site
Leipzig, Germany, 04157
Novartis Investigative Site
Leipzig, Germany, 04275
Novartis Investigative Site
Leipzig, Germany, 04357
Novartis Investigative Site
Loehne, Germany, 32584
Novartis Investigative Site
Lubeck, Germany, 23552
Novartis Investigative Site
Ludwigsburg, Germany, 71640
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Mannheim, Germany, 68165
Novartis Investigative Site
Marburg, Germany, 35037
Novartis Investigative Site
Marburg, Germany, D-35037
Novartis Investigative Site
Menden, Germany, 58706
Novartis Investigative Site
Mittweida, Germany, 09648
Novartis Investigative Site
Munchen, Germany, 81241
Novartis Investigative Site
Potsdam, Germany, 14467
Novartis Investigative Site
Prien A Chiemsee, Germany, 83209
Novartis Investigative Site
Rheine, Germany, 48431
Novartis Investigative Site
Rudersdorf, Germany, 15562
Novartis Investigative Site
Schleswig, Germany, 24837
Novartis Investigative Site
Schwetzingen, Germany, 68723
Novartis Investigative Site
Witten, Germany, 58452
Greece
Novartis Investigative Site
Athens, GR, Greece, 115 27
Novartis Investigative Site
Thessaloniki, GR, Greece, 564 29
Novartis Investigative Site
Thessaloniki, GR, Greece, 570 10
Novartis Investigative Site
Athens, Greece, 12462
Hungary
Novartis Investigative Site
Puspokladany, HUN, Hungary, 4150
Novartis Investigative Site
Balassagyarmat, Hungary, 2660
Novartis Investigative Site
Godollo, Hungary, 2100
Novartis Investigative Site
Komlo, Hungary, 7300
Novartis Investigative Site
Sellye, Hungary, 7960
Novartis Investigative Site
Siofok, Hungary, 8600
Novartis Investigative Site
Szarvas, Hungary, 5540
Novartis Investigative Site
Szeged, Hungary, 6722
India
Novartis Investigative Site
Vijayawada, Andhra Pradesh, India, 520008
Novartis Investigative Site
Kozhikode, Kerala, India, 673008
Novartis Investigative Site
Nagpur, Maharashtra, India, 440019
Novartis Investigative Site
Pune, Maharashtra, India, 411014
Novartis Investigative Site
Mohali, Punjab, India, 160 062
Novartis Investigative Site
Coimbatore, Tamil Nadu, India, 641 045
Novartis Investigative Site
Vellore, Tamil Nadu, India, 632004
Novartis Investigative Site
Hyderabad, Telangana, India, 500 038
Novartis Investigative Site
Kolkata, West Bengal, India, 700 107
Israel
Novartis Investigative Site
Jerusalem, Israel
Novartis Investigative Site
Ramat Gan, Israel, 5266202
Novartis Investigative Site
Rehovot, Israel, 76100
Mexico
Novartis Investigative Site
Mexico, Distrito Federal, Mexico, 14050
Novartis Investigative Site
Guadalajara, Jalisco, Mexico, 44100
Novartis Investigative Site
Guadalajara, Jalisco, Mexico, 44160
Peru
Novartis Investigative Site
San Martin de Porres, Lima, Peru, 31
Novartis Investigative Site
Santiago de Surco, Lima, Peru, 33
Novartis Investigative Site
Cusco, Peru, 84
Novartis Investigative Site
Lima, Peru, 1
Poland
Novartis Investigative Site
Katowice, Poland, 40-648
Novartis Investigative Site
Poznan, Poland, 60 823
Novartis Investigative Site
Poznan, Poland, 60-214
Novartis Investigative Site
Poznan, Poland, 60-693
Russian Federation
Novartis Investigative Site
Izhevsk, Russian Federation, 426061
Novartis Investigative Site
Kemerovo, Russian Federation, 650002
Novartis Investigative Site
Moscow, Russian Federation, 105275
Novartis Investigative Site
Moscow, Russian Federation, 109544
Novartis Investigative Site
Moscow, Russian Federation, 123423
Novartis Investigative Site
Nizhny Novgorod, Russian Federation, 603018
Novartis Investigative Site
Novosibirsk, Russian Federation, 630102
Novartis Investigative Site
Saint Petersburg, Russian Federation, 194354
Novartis Investigative Site
Saint Petersburg, Russian Federation, 197022
Novartis Investigative Site
Saint-Petersburg, Russian Federation, 191186
Novartis Investigative Site
Saint-Petersburg, Russian Federation, 196143
Novartis Investigative Site
Saratov, Russian Federation, 410012
Novartis Investigative Site
Smolensk, Russian Federation
Novartis Investigative Site
St Petersburg, Russian Federation, 193312
Novartis Investigative Site
Ulyanovsk, Russian Federation, 432063
Novartis Investigative Site
Vsevolozhsk, Russian Federation, 188640
Novartis Investigative Site
Yekaterinburg, Russian Federation, 620109
Serbia
Novartis Investigative Site
Belgrade, Serbia, 11000
Novartis Investigative Site
Kragujevac, Serbia, 34000
Novartis Investigative Site
Nis, Serbia, 18000
Novartis Investigative Site
Sremska Kamenica, Serbia, 21204
Singapore
Novartis Investigative Site
Singapore, SGP, Singapore, 168937
Novartis Investigative Site
Singapore, Singapore, 519457
Slovakia
Novartis Investigative Site
Bojnice, Slovak Republic, Slovakia, 972 01
Novartis Investigative Site
Humenne, Slovak Republic, Slovakia, 066 01
Novartis Investigative Site
Liptovsky Hradok, Slovak Republic, Slovakia, 033 01
Novartis Investigative Site
Liptovsky Mikulas, Slovakia, 031 23
Novartis Investigative Site
Topolcany, Slovakia, 95501
Novartis Investigative Site
Zilina, Slovakia, 01001
South Africa
Novartis Investigative Site
Berea, Durban, South Africa, 4001
Novartis Investigative Site
Cape Town, South Africa, 7531
Novartis Investigative Site
Cape Town, South Africa, 7925
Novartis Investigative Site
Chatsworth, South Africa, 4092
Novartis Investigative Site
Kempton Park, South Africa, 1619
Novartis Investigative Site
Pretoria, South Africa, 0183
Spain
Novartis Investigative Site
Marbella, Andalucia, Spain, 29600
Novartis Investigative Site
Sevilla, Andalucia, Spain, 41009
Novartis Investigative Site
Centelles, Barcelona, Spain, 08540
Novartis Investigative Site
Esparraguera, Barcelona, Spain, 08292
Novartis Investigative Site
Hostalets De Balenya, Cataluna, Spain, 08550
Novartis Investigative Site
Alzira, Comunidad Valenciana, Spain, 46600
Novartis Investigative Site
Caceres, Extremadura, Spain, 10003
Novartis Investigative Site
Benalmadena, Malaga, Spain, 29639
Novartis Investigative Site
Madrid, Spain, 28006
Taiwan
Novartis Investigative Site
Kaoshiung, Taiwan, 80756
Novartis Investigative Site
New Taipei City, Taiwan, 23561
Novartis Investigative Site
Taichung, Taiwan, 40447
Novartis Investigative Site
Taipei, Taiwan, 10449
Novartis Investigative Site
Taoyuan, Taiwan, 33305
Turkey
Novartis Investigative Site
Izmir, Turkey, 35040
Novartis Investigative Site
Mersin, Turkey, 33343
Novartis Investigative Site
Yenisehir/Izmir, Turkey, 35110
Vietnam
Novartis Investigative Site
Ho Chi Minh, VNM, Vietnam, 700000
Novartis Investigative Site
Hanoi, Vietnam, 100000
Novartis Investigative Site
Ho Chi Minh, Vietnam, 700000
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03158311    
Other Study ID Numbers: CQVM149B2306
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
QVM149
asthma
adult
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Tiotropium Bromide
Salmeterol Xinafoate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents