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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 )

Tracking Information
First Submitted Date  ICMJE May 16, 2017
First Posted Date  ICMJE May 18, 2017
Last Update Posted Date September 20, 2019
Actual Study Start Date  ICMJE February 5, 2018
Actual Primary Completion Date July 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03158311 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2017)
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2017)
  • 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.
  • 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
  • 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.
  • Percentage of patients achieving the minimal important difference (MID) change from baseline ACQ-7 ≥ 0.5 decrease [ Time Frame: 16 weeks, 24 weeks ]
    Responder rate; MID for ACQ-7 is 0.5 decrease.
  • Percentage of patients achieving the minimal important difference (MID) change from baseline AQLQ ≥ 0.5 decrease [ Time Frame: 16 weeks, 24 weeks ]
    Responder rate; MID for AQLQ is 0.5 decrease.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Compare QVM149 and Free Triple Combination of Salmeterol/Fluticasone + Tiotropium
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: QVM149
    Indacaterol acetate / Glycopyrronium bromide / Mometasone furoate
  • Drug: Salmeterol/fluticasone plus tiotropium
    free triple arm of Salmeterol/fluticasone plus tiotropium
Study Arms  ICMJE
  • Experimental: QVM149 arm 1
    QVM149 150/50/80 μg o.d. delivered via Concept1
    Intervention: Drug: QVM149
  • Experimental: QVM149 arm 2
    QVM149 150/50/160 μg o.d. delivered via Concept1
    Intervention: Drug: QVM149
  • 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®
    Intervention: Drug: Salmeterol/fluticasone plus tiotropium
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 18, 2019)
1436
Original Estimated Enrollment  ICMJE
 (submitted: May 16, 2017)
1500
Actual Study Completion Date  ICMJE July 19, 2019
Actual Primary Completion Date July 12, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Chile,   Colombia,   Czechia,   Germany,   Greece,   Hungary,   India,   Israel,   Mexico,   Peru,   Poland,   Russian Federation,   Serbia,   Singapore,   Slovakia,   South Africa,   Spain,   Taiwan,   Turkey,   Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03158311
Other Study ID Numbers  ICMJE CQVM149B2306
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP