This is a multi-centre, randomized, double-blind,placebo parallel-controlled phase III study to evaluate the efficacy and safety of CMAB007 (recombinant humanized anti-immunoglobulin E(IgE) monoclonal antibody for injection) to treat asthma patients who remain not adequately controlled despite Med/high ICS plus LABA in China. Following a screening period of up to 2 weeks and run-in period of 4 weeks, randomized patients will enter a 24-week treatment period with CMAB007 or placebo. Efficacy and safety will be assessed at 4-week intervals during the treatment period.
Approximately 400 asthma patients with an increased serum total IgE level(60-1500 international unit(IU)/ml) and uncontrolled receiving medium to high dose inhaled corticosteroid (ICS) plus long-acting β2-agonist(LABA) will be randomised in about 43 sites in China. They will be administered CMAB007 or placebo at a ratio of 2:1 for 24 weeks. During the whole study, all subjects will be on regularly fixed combination of med/high ICS and LABA (budesonide and formoterol fumarate powder for inhalation or salmeterol xinafoate and fluticasone propionate powder for inhalation). They should complete PEF measurement and patient diary daily and be assessed every 4 weeks. Spirometry, questionnaires, laboratory tests and so on will be performed. At selected sites, about 45 patients will be enrolled in a sub-study to assess the pharmacokinetic and pharmacodynamic characterises of CMAB007. Anti-drug antibody (ADA) will be sampled at V1, V2 and V7 too.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
393
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
the mean number of asthma exacerbations per patient during the 24-week treatment period
Asthma exacerbation is defined by a worsening of asthma symptoms resulting in: 1.out-planned outpatient visit; 2.use of systemic and/or nebulized inhaled corticosteroids; 3.emergency room visit; 4. hospitalization.
Time frame: from baseline(0 week) to 24 weeks
the proportion of patients with asthma exacerbations during the 24-week treatment period
the number of patients with at least one exacerbations divided by the total number of patients.
Time frame: from baseline(0 week) to 24 weeks
time to the first asthma exacerbation during treatment period
the time from baseline to the first asthma exacerbation
Time frame: from baseline(0 week) to 24 weeks
change from baseline in asthma symptom scores(daytime, nocturnal and total) over the 24-week treatment period
mean asthma symptom scores(daytime, nocturnal and total): (pre-treatment - post-treatment)/pre-treatment \*100%
Time frame: from baseline(0 week) to 24 weeks
change from baseline in Asthma Control Test(ACT) over the 24-week treatment period
ACT total score: (pre-treatment - post-treatment)/pre-treatment \*100%
Time frame: from baseline(0 week) to 24 weeks
change from baseline in Asthma Quality of Life Questionnaire(AQLQ) over the 24-week treatment period
AQLQ total score and threshold score: (pre-treatment - post-treatment)/pre-treatment \*100%
Time frame: from baseline(0 week) to 24 weeks
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asthma rescue drug
No active components
investigator's and patient's Global Evaluation of Treatment Effectiveness(GETE) over 16 and 24-week treatment period
GETE score at week 16 and 24
Time frame: from baseline(0 week) to 16 and 24 weeks
change from baseline in rescue medication use over the 24-week treatment period
mean rescue medication use(puff/day): (pre-treatment - post-treatment)/pre-treatment \*100%
Time frame: from baseline(0 week) to 24 weeks
change from baseline in lung function parameters(FEV1,FVC and FEV1/FVC) over the 24-week treatment period
FEV1,FVC and FEV1/FVC values: (post-treatment - pre-treatment)/pre-treatment \*100%
Time frame: from baseline(0 week) to 24 weeks
change from baseline in mean peak expiratory flow(PEF) over the 24-week treatment period
mean PEF value: (post-treatment - pre-treatment)/pre-treatment \*100%
Time frame: from baseline(0 week) to 24 weeks