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

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ClinicalTrials.gov Identifier: NCT03158311
Recruitment Status : Recruiting
First Posted : May 18, 2017
Last Update Posted : April 4, 2018
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1251 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
Estimated Primary Completion Date : June 21, 2019
Estimated Study Completion Date : June 28, 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.



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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


Contacts
Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
Argentina
Novartis Investigative Site Recruiting
Caba, Buenos Aires, Argentina, C1122AAK
Novartis Investigative Site Recruiting
Caba, Buenos Aires, Argentina, C1414AIF
Novartis Investigative Site Recruiting
Buenos Aires, Argentina, C1425FVH
Germany
Novartis Investigative Site Recruiting
Peine, Niedersachsen, Germany, 31224
Novartis Investigative Site Recruiting
Geesthacht, Schleswig Holstein, Germany, 12502
Novartis Investigative Site Recruiting
Arnsberg, Germany, 59755
Novartis Investigative Site Recruiting
Aschaffenburg, Germany, 63739
Novartis Investigative Site Recruiting
Auerbach, Germany, 08209
Novartis Investigative Site Recruiting
Augsburg, Germany, 86150
Novartis Investigative Site Recruiting
Berlin, Germany, 10119
Novartis Investigative Site Recruiting
Berlin, Germany, 10625
Novartis Investigative Site Recruiting
Berlin, Germany, 12157
Novartis Investigative Site Recruiting
Berlin, Germany, 12159
Novartis Investigative Site Recruiting
Berlin, Germany, 13086
Novartis Investigative Site Recruiting
Berlin, Germany, 13156
Novartis Investigative Site Recruiting
Berlin, Germany, 13187
Novartis Investigative Site Recruiting
Berlin, Germany, 14050
Novartis Investigative Site Recruiting
Boehlen, Germany, 04564
Novartis Investigative Site Recruiting
Bonn, Germany, 53123
Novartis Investigative Site Recruiting
Darmstadt, Germany, 64283
Novartis Investigative Site Recruiting
Dortmund, Germany, 44263
Novartis Investigative Site Recruiting
Frankfurt, Germany, 60596
Novartis Investigative Site Recruiting
Furstenwalde, Germany, 15517
Novartis Investigative Site Recruiting
Gifhorn, Germany, 38518
Novartis Investigative Site Recruiting
Hannover, Germany, 30173
Novartis Investigative Site Recruiting
Leipzig, Germany, 04103
Novartis Investigative Site Recruiting
Leipzig, Germany, 04157
Novartis Investigative Site Recruiting
Leipzig, Germany, 04275
Novartis Investigative Site Recruiting
Leipzig, Germany, 04357
Novartis Investigative Site Recruiting
Lubeck, Germany, 23552
Novartis Investigative Site Recruiting
Marburg, Germany, 35037
Novartis Investigative Site Recruiting
Marburg, Germany, D-35037
Novartis Investigative Site Recruiting
Mittweida, Germany, 09648
Novartis Investigative Site Recruiting
Potsdam, Germany, 14467
Novartis Investigative Site Recruiting
Prien A. Chiemsee, Germany, 83209
Novartis Investigative Site Recruiting
Schleswig, Germany, 24837
Novartis Investigative Site Recruiting
Witten, Germany, 58452
Turkey
Novartis Investigative Site Recruiting
Mersin, Turkey, 33343
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03158311     History of Changes
Other Study ID Numbers: CQVM149B2306
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
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