Abstract

ASSESSMENT OF THE SAFETY AND EFFICACY OF GRC-3886 IN THE TREATMENT OF MILD TO MODERATE PERSISTENT ASTHMA PATIENTS

*Mathew George*, Lincy Joseph, Vishal Thakkar, Jisha Annie

ABSTRACT

Oral Type 4 phosphodiesterase inhibitors (e.g. roflumilast) have provided evidence of clinical efficacy in both asthma and chronic obstructive pulmonary disease (COPD). The objectives were to evaluate the efficacy, safety and tolerability of oglemilast at 3 dose levelscompared with placebo for the treatment of mild to moderate persistent asthma, to investigate the pharmacokinetics of oglemilast and its N-oxide metabolite, to investigate the effects of oglemilast on pharmacodynamics parameters in sputum and blood. This is a randomized, double-blind, placebo controlled, parallel group phase II study to evaluate the efficacy of 3 doses (0.2, 0.4, 0.8 mg) of drug-x administered for 12 weeks once daily. A total of 30 patients of mild to moderate persistent asthma were screened. From the 30 patients, total 27 patients are eligible for randomization and they get the Drug-x as well as placebo. In the study, the spirometry and symptom score which are recorded by the patient in their dairy for evaluation of result of the study were taken. Patients brought for the study medication their paper diary to every study visit. Safety status assessed by clinical laboratory tests, vital signs, physical examination (including electrocardiogram [ECG]), monitoring of asthma symptoms and adverse events. It was seen that patients who received the Drug-x shows marked improvement in spirometry parameters from visit V1 to visit Vend. Drug-x has significant safety profile and it can be used for management of asthma.

Keywords: Type 4 phosphodiesterase inhibitors, Safety, Efficacy, Spirometry, Asthma.