These results were presented at the ECTRIMS, ACTRIMS and LACTRIMS conference in September. This trial was listed in phase 2 as "Albuterol (aka Proventil) (with Copaxone)". The trial is done, so I'm removing it from the list.
Treatment of multiple sclerosis with glatiramer acetate and albuterol: results of a clinical trial
P. Kivisäkk1; V. Viglietta2; B. Healy1; G. J. Buckle1; H. L. Weiner1; D. A. Hafler1; S. Khoury1
1. Brigham and Women's Hospital, Boston, MA, USA., 2. EMD Serono, Boston, MA, USA.
The mechanism of action of glatiramer acetate (GA) is thought to be by induction of anergy of GA reactive lines and enhanced production of Th2 cytokines. We hypothesized that albuterol may enhance the effects of GA in vivo or accelerate the induction of anergy and Th2 cytokine production.
In a randomized, double-masked, two-arm pilot study we investigated the effect of adding oral albuterol versus placebo to GA in relapsing–remitting multiple sclerosis (RRMS).
Eligibility criteria were clinically definite RRMS with positive brain magnetic resonance imaging (MRI), and an Expanded Disability Status Scale (EDSS) score between 0 and 3.5. No prior treatment with GA or oral myelin. No treatment with immunomodulating therapy within the past 3 months. No prior treatment with immunosuppressants. No steroid treatment 1 month prior to study entry. Subjects were randomized to two treatment arms: 20mg SQ of GA daily + 4mg PO of placebo daily for 2 years or 20mg SQ of GA daily + 4mg PO of albuterol daily, for 2 years.
The primary outcome measures were the change in the MS Functional Scale (MSFC), and the change in IL-13 and IFN-γ cytokine secretion by GA reactive T cell lines. Secondary outcome variables included changes in percentage of IL-12-producing monocytes by intra-cytoplasmic staining, time of first exacerbation, number and severity of exacerbations, and MRI evidence of progression.
Forty four subjects were randomized (21 in the GA+placebo arm and 23 in the GA+albuterol arm). There was a treatment effect of albuterol on MSFC at 6 months that diminished over time (p=0.026) and a trend for improved MSFC in the albuterol arm at 12 months. Analysis of the immunologic endpoints is ongoing.
Albuterol added to GA treatment in RRMS enhanced treatment response in the early time points and may be beneficial in accelerating the beneficial effects of therapy.