Are Corticosteroids Enough to Control Your Asthma?

Are Corticosteroids Enough to Control Your Asthma?

Posted on August 15, 2012 by Barbara Cybart in Asthma Research

A Comparison of Clinical Trials

In 2012, Genentech opened two asthma clinical trials. One, “A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Dosing Regimens of MEMP1972A in Adults With Allergic Asthma Who Are Inadequately Controlled on Inhaled Corticosteroids and a Second Controller (COSTA)” was begun in April while  the other “A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and A Second Controller Medication” was started in March.  Both clinical trials are conducted in the same study style and have the same study design: the study allocation is randomized, the endpoint classification is a safety/efficacy study, the intervention model is a parallel assignment, both are double blind (subject and investigator) and the primary purpose of the studies is treatment albeit through two different medications. Furthermore, though each has slightly different inclusion and exclusion criteria, there are some similarities. For inclusion criteria: ages from 18 to 75 inclusively, both genders and inadequately controlled asthma despite compliance with asthma controller therapy. While for exclusion criteria: known immunodeficiency, including but not limited to HIV infection, regardless of treatment status, current substance abuse, former smoke with 10 plus pack a year history or current smoker, former smokers must have stopped smoking more than 12 months prior to Visit 1, history of anaphylaxis and pregnant or lactating women.

The “A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Dosing Regimens of MEMP1972A in Adults With Allergic Asthma Who Are Inadequately Controlled on Inhaled Corticosteroids and a Second Controller (COSTA)” trial is testing the drug  MEMP1972A. The study will evaluate the efficacy and safety of 3 dosage regimes of MEMP1972A in patients with allergic asthma who remain inadequately controlled on chronic therapy with high dose inhaled corticosteroids and a second controller medication. The anticipated time on this phase 2 study treatment is 36 weeks, with a 48-week follow-up. The drug MEMP1972A would be administered through a repeating subcutaneous dose.[1] It is estimated that the trial will be completed in November of 2015.

The drug lebrikizumab was tested in the second study, “A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Dosing Regimens of MEMP1972A in Adults With Allergic Asthma Who Are Inadequately Controlled on Inhaled Corticosteroids and a Second Controller (COSTA)”. The purpose of the study was to assess the efficacy and safety of lebrikizumab in patients with asthma whose disease remains uncontrolled despite daily therapy with an inhaled corticosteroid and a second controller medication. The anticipated time on this phase 3 study treatment is 52 weeks, in addition to their standard-of-care therapy. This will be followed by a 52-week double-blind active treatment extension. The anticipated time on study treatment is up to 104 weeks. There will be a safety follow-up of 24 weeks after the last dose of study drug for all patients. The drug lebrikizumab would be administered by subcutaneous injection every 4 weeks.[2] It is estimated that the trial will be completed in June of 2017.

This comparison demonstrated that clinical trial methodology is strictly adhered to, and that there were many similarities between two trials studying entirely different asthma medications, MEMO1972A and lebrikizumab. This procedural unity contributes to ensuring the safest and most effective means of clinical trial testing.


[1] A Study of MEMP1972A in Patients With Allergic Asthma Inadequately Controlled on Inhaled Steroids And A Second Controller (COSTA). Accessed August 2, 2012. http://clinicaltrials.gov/ct2/show/study/NCT01582503?term=GB27980&rank=1

[2] A Study of Lebrikizumab in Patients Whose Asthma is Uncontrolled With Inhaled Corticosteroids and A Second Controller Medication (LUTE). Accessed August 2, 2012. http://clinicaltrials.gov/ct2/show/NCT01545440?term=GB27862&rank=1