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A Study to Establish the Efficacy of QBX258 in Patients With Moderate to Severe Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01479595
First received: November 22, 2011
Last updated: June 20, 2016
Last verified: June 2016

November 22, 2011
June 20, 2016
February 2012
February 2015   (final data collection date for primary outcome measure)
Change From Baseline in Asthma Control Questionnaire (ACQ) Score [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
The ACQ consists of 7 questions assessing symptoms, rescue medication use and lung function. Except for lung function (FEV1), each question was scored on a 7-point scale where 0 = no impairment and 6 = maximum impairment. Scores ranged between 0 totally controlled to 6 (severely uncontrolled). Participants with a score below 1.0 are considered to have adequately controlled asthma. Participants with a score above 1.0 were considered not to be well controlled. A negative change from baseline indicates improvement.
Change in Asthma Control Questionnaire score [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01479595 on ClinicalTrials.gov Archive Site
  • Change in Forced Expiratory Volume in One Second (FEV1) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    FEV1 was assessed using central spirometry according to the American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.
  • Change in Asthma Quality of Life Questionnaire (AQLQ) Score [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

    The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to patients with asthma. It consists of 4 domains: symptoms, emotions., exposure to environmental stimuli and activity limitation.

    Patients were asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale. The scale ranges from 1 to 7. The overall AQLQ score was the mean response to all 32 questions. Higher scores represent better outcomes.

  • Morning and Evening Peak Expiratory Flow (PEF) Rate [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Morning and evening PEFs were recorded on an electronic diary (e-diary). PEF was assessed twice daily approximately 12 hours apart and the measurements were recorded in the e-diary.
  • Change From Baseline in Maximum Expiratory Flow [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Maximum expiratory flow was assessed using central spirometry according to the American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.
  • Number of Participants With Anti-QAX576 Antibodies or Anti-VAK694 Antibodies [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Anti-QAX576 and anti-VAK694 antibodies in serum were analyzed.
  • Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) of the QAX576 Analyte [ Time Frame: days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183 ] [ Designated as safety issue: No ]
    Blood samples were obtained to measure Cmax,ss.
  • Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) of the VAK694 Analyte [ Time Frame: days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183 ] [ Designated as safety issue: No ]
    Blood samples were obtained to measure Cmax,ss.
  • Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin,ss) of the QAX576 Analyte [ Time Frame: days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183 ] [ Designated as safety issue: No ]
    Blood samples were obtained to measure Cmin,ss.
  • Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin,ss) of the VAK694 Analyte [ Time Frame: days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183 ] [ Designated as safety issue: No ]
    Blood samples were obtained to measure Cmin,ss.
  • Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
    FeNO was assessed as a measure of airway inflammation. An FeNO machine was used to obtain the FeNO measurements. FeNO measurements were obtained prior to the spirometry assessments.
  • Change in Forced Expiratory Volume in One Second (FEV1) [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
  • Change in Asthma Quality of Life Questionnaire score [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Morning and evening peak expiratory flow rate [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study to Establish the Efficacy of QBX258 in Patients With Moderate to Severe Asthma
A Randomized Double-blind Multiple-dose Placebo-controlled Trial to Establish the Efficacy of QBX258 (Combination of VAK694 and QAX576) in Asthma That is Inadequately Controlled With Inhaled Corticosteroids and Long Acting Beta Agonists
This study is designed to investigate the efficacy and safety of QBX258 in subjects with moderate to severe asthma.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • Drug: QBX258
    QBX258 infusion, a combination of VAK694 and QAX576, was supplied to the Investigator as open label bulk medication. The planned dose of VAK694 (lyophilisate in vial, 150 mg/vial), was 3 mg/kg. The planned dose of QAX576 (lyophilisate in vial, 150 mg/vial), was 6 mg/kg.
  • Drug: Placebo
    The placebo infusion was an equal volume of 5% dextrose for infusion and was provided by the clinical site.
  • Experimental: QBX258
    Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
    Intervention: Drug: QBX258
  • Placebo Comparator: Placebo
    Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
February 2015
February 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with atopic asthma >1 year duration diagnosed according to the GINA guidelines.
  • Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 39 kg/m2.
  • Asthma which is not adequately controlled on current treatment, as demonstrated by an Asthma Control Questionnaire (ACQ) score of > 1.5.
  • FEV1 40 to 90% of predicted.

Exclusion Criteria:

  • Diagnosed with COPD as defined by the GOLD guidelines
  • Subjects who have had a respiratory tract infection within 4 weeks prior to screening.
  • Women of child-bearing potential must use highly effective methods of contraception during dosing and for at least 18 weeks after last study drug administration
Both
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   United Kingdom
 
NCT01479595
CQBX258X2201, 2011-003066-32
No
Not Provided
Not Provided
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis
Novartis
June 2016

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