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Home » LAB INTERNATIONAL REPORTS POSITIVE RESULTS FROM ASTHMA TRIAL
LAB INTERNATIONAL REPORTS POSITIVE RESULTS FROM ASTHMA TRIAL
LAB International has announced positive results from the first Phase II clinical trial of its LAB CGRP product. LAB CGRP showed statistically significant broncho-protective effects compared with placebo and a similar safety profile to placebo except for transient and mild headaches and flushing in some of the patients.
The objectives of this randomized, double blind, cross-over Phase II study were to investigate the protective efficacy of LAB CGRP on metacholine-induced bronchial hyper-responsiveness in adult patients with mild to moderate asthma, to compare this efficacy with salbutamol and placebo and to evaluate the safety and tolerability of LAB CGRP in asthma patients. The trial reached statistical difference, according to the company.
Each patient received one dose of LAB CGRP (5 mg), one dose of salbutamol sulphate (500 micrograms) and one dose of placebo. The doses were given in a randomized order, and study agents were compared in terms of absolute provocative concentration (PC20) of methacholine causing at least 20 percent fall in forced expiratory ventilation volume. LAB CGRP increased PC20 in a majority of patients (seven out of 12), while Salbutamol and placebo achieved 11 and two out of 12, respectively. On average, the PC20 with LAB CGRP was approximately twice that of placebo.
LAB CGRP is a 37 amino acid natural neuropeptide produced in the lung in response to allergic stimuli. As a drug candidate, it has demonstrated in preclinical studies a profile that could make it an ideal anti-asthmatic drug with broncho-dilatory, broncho-protecting and anti-inflammatory properties.
KEYWORDS Drug Pipeline Alert
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