Randomized, Placebo-Controlled Lebrikizumab Trials

LUTE and VERSE were replicate, randomised, multicentre, double-blind, placebo-controlled studies (NCT01545440 and NCT01545453). The studies were initially designed to enrol approximately 1400 patients each and to include a 52-week double-blind treatment period (see below for study modification). Patients were randomised in a 1:1:1:1 ratio to receive lebrikizumab 37.5, 125, 250 mg, or placebo subcutaneously every four weeks. Randomisation was stratified by baseline serum periostin level, history of asthma exacerbations within the last 12 months and baseline asthma medications. All patients remained on their standard-of-care therapy that consisted of 500–2000 μg/day ICS therapy (fluticasone propionate dry powder inhaler (DPI) or equivalent) and a second eligible asthma controller medication.

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Hanania N.A., Noonan M., Corren J., Korenblat P., Zheng Y., Fischer S.K., Cheu M., Putnam W.S., Murray E., Scheerens H., Holweg C.T., Maciuca R., Gray S., Doyle R., McClintock D., Olsson J., Matthews J.G, & Yen K. (2015). Lebrikizumab in moderate-to-severe asthma: pooled data from two randomised placebo-controlled studies. Thorax, 70(8), 748-756.

Publication 2015

Asthma Dry powder inhaler Fluticasone propionate Lebrikizumab Medication Patients Periostin Placebo Replicate Serum Therapy

Corresponding Organization :

Other organizations : Baylor College of Medicine, Allergy Associates Research Center, Asthma and Allergy Foundation of America, Roche (United States), Roche (Switzerland)

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Variable analysis

independent variables

Lebrikizumab 37.5 mg subcutaneously every four weeks
Lebrikizumab 125 mg subcutaneously every four weeks
Lebrikizumab 250 mg subcutaneously every four weeks
Placebo subcutaneously every four weeks

dependent variables

Asthma exacerbations
Asthma symptoms
Lung function
Other clinical outcomes

control variables

Standard-of-care therapy consisting of 500–2000 μg/day ICS therapy (fluticasone propionate dry powder inhaler (DPI) or equivalent) and a second eligible asthma controller medication
Baseline serum periostin level
History of asthma exacerbations within the last 12 months
Baseline asthma medications

negative controls

Placebo

Annotations

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