RNS60 improves physiological parameters without adverse events or safety concerns in Phase I trial
MONDAY, Nov. 7 (HealthDay News) -- RNS60 is safe and improves physiological parameters in patients with mild to moderate asthma, according to a study being presented at the annual meeting of the American College of Allergy, Asthma & Immunology, held from Nov. 3 to 8 in Boston.
Richard Watson, M.D., from the Revalesio Corporation in Tacoma, Wash., and colleagues investigated the clinical efficacy and tolerability of nebulized RNS60 in a Phase I trial. In the first stage, a single administration was delivered to 10 healthy volunteers and 10 individuals with mild to moderate asthma. In the second stage, 14 patients with mild to moderate asthma received RNS60 twice daily for 28 days. Forced expiratory volume in one second (FEV1), recorded at baseline and hourly for eight hours (single dose groups) or weekly for four weeks (multiple dose groups), was the primary end point. Clinical activity analysis, physician's global assessment, Quality of Life Questionnaires (QLQ-Asthma), and peak flow meter examination were measured.
The investigators found that there was a consistent, nonsignificant trend toward increased FEV1 across all groups. In the single-dose stage, a maximal FEV1 increase of 2.05 and 0.75 percent was seen in healthy volunteers and patients with mild to moderate asthma, respectively. FEV1 increased by 0.94, 0.99, and 0.64 percent, on days 21, 28, and 30, respectively, during post-study follow-up in the second stage. In addition, there was a significant improvement in peak flow and QLQ from day one though day 28. No adverse events or safety concerns were reported.
"These results indicate RNS60 as a promising candidate for a novel, low-risk asthma therapeutic," the authors write.
The study was funded by Revalesio Corporation.