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Completed

NCT Number: NCT01479595

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

This study is designed to investigate the efficacy and safety of QBX258 in subjects with moderate to severe asthma.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Wiesbaden, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QBX258

Drug

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.

Placebo

Drug

The placebo infusion was an equal volume of 5% dextrose for infusion and was provided by the clinical site.

Primary outcomes

  1. Change From Baseline in Asthma Control Questionnaire (ACQ) Score

    Time frame: Baseline and 12 weeks

    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.

Secondary outcomes

  1. Change in Forced Expiratory Volume in One Second (FEV1)

    Time frame: Baseline and 12 weeks

    FEV1 was assessed using central spirometry according to the American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.

  2. Change in Asthma Quality of Life Questionnaire (AQLQ) Score

    Time frame: Baseline and 12 weeks

    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.

  3. Morning and Evening Peak Expiratory Flow (PEF) Rate

    Time frame: Baseline and 12 weeks

    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.

  4. Change From Baseline in Maximum Expiratory Flow

    Time frame: Baseline and 12 weeks

    Maximum expiratory flow was assessed using central spirometry according to the American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.

  5. Number of Participants With Anti-QAX576 Antibodies or Anti-VAK694 Antibodies

    Time frame: 12 weeks

    Anti-QAX576 and anti-VAK694 antibodies in serum were analyzed.

  6. 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

    Blood samples were obtained to measure Cmax,ss.

  7. 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

    Blood samples were obtained to measure Cmax,ss.

  8. 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

    Blood samples were obtained to measure Cmin,ss.

  9. 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

    Blood samples were obtained to measure Cmin,ss.

  10. Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)

    Time frame: baseline, 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 24, 2011
Registry last updated
Aug 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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