Clinical Trials Resource Center

Chronic Obstructive Lung Disease

September 10, 2012

Boehringer Ingelheim released results from a phase II adjunctive trial of tiotropium for the treatment of chronic obstructive pulmonary disease (COPD). This randomized, double-blind, four-period, crossover study enrolled 232 patients with post-bronchodilator FEV1 of ≥30% and <80% of predicted normal. Subjects received tiotropium 1.25μg, 2.5μg or 5μg in combination with olodaterol 5μg or 10μg, or olodaterol and placebo, for four weeks. Results showed the free combination of tiotropium and olodaterol provided an average lung function improvement of up to 342mL over the first six hours after four weeks of treatment (FEV1 AUC0-6) compared to pre-dose lung function mean baseline values and improvements in trough FEV1 of up to 166mL, compared to pre-treatment FEV1 mean baseline values. Tiotropium was well tolerated. The most frequent adverse events were nasopharyngitis and COPD. This study completes a comprehensive phase II program to thoroughly investigate different doses of each active component to identify the appropriate doses for the fixed-dose combination.

Elevation Pharmaceuticals issued results from a phase IIb trial of EP-101 for the treatment of chronic obstructive pulmonary disease (COPD). This randomized, placebo-controlled, double-blind, seven-arm, four-period cross-over, block design, dose-ranging study, GOLDEN-1, enrolled 140 patients with moderate to severe COPD. Subjects received EP-101 25μg, 50μg, 100μg or 200μg daily or placebo for seven days. Data demonstrated that all doses of EP-101 showed a rapid onset, dose-related, statistically significant improvement in lung function compared to placebo. Improvements in lung function with EP-101 doses were comparable to those of once-daily tiotropium dry powder inhaler and three-times daily nebulized ipratropium administered via jet nebulizer. The drug was well tolerated. The most frequent adverse events were cough and headache. Elevation Pharmaceuticals will be initiating a second phase IIb study in Q4 2012 to select the dose for phase III studies.

September 3, 2012

MediciNova reported preliminary results from a phase Ib trial of MN-221 for the treatment of chronic obstructive pulmonary disease (COPD). This randomized, placebo-controlled study enrolled 25 patients with stable, moderate-to-severe COPD. Subjects received six intravenous infusions of 1200µg MN-221 or placebo over four days. Results indicate moderately improved pulmonary function (FEV1) in MN-221 recipients, but not the placebo recipients. Moreover, the improvement of FEV1 on subsequent MN-221 dosing days was as good as or better than on day one. In addition, there was no significant ccumulation of plasma MN-221 over the multiple dosing intervals. The drug was well tolerated. Two MN-221 recipients with pre-existing heart disorders were terminated from the study due to transient arrhythmias identified by electrocardiograph monitoring that did not have clinical symptoms or consequences and resolved spontaneously. MediciNova will meet with the FDA in October for an end-of-phase II meeting.

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