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

Phase 2CompletedNCT01479595

Novartis Pharmaceuticals65 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Asthma

Interventions

QBX258DRUG

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.

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (20)

Novartis Investigative Site

Anaheim, California, United States

Novartis Investigative Site

Outcomes

Primary Outcomes

Change From Baseline in Asthma Control Questionnaire (ACQ) Score

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.

Time frame: Baseline and 12 weeks

Secondary Outcomes

Change in Forced Expiratory Volume in One Second (FEV1)

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

Time frame: Baseline and 12 weeks

Change in Asthma Quality of Life Questionnaire (AQLQ) Score

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.

Time frame: Baseline and 12 weeks

Morning and Evening Peak Expiratory Flow (PEF) Rate

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.

Time frame: Baseline and 12 weeks

Change From Baseline in Maximum Expiratory Flow

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

Data from ClinicalTrials.gov

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