A Phase 2, Randomized, Double-Blind, Multiple-Dose, Five-Period, Incomplete-Block, Crossover Study to Examine the Pharmacodynamics, Safety and Tolerability, and Pharmacokinetics of Multiple Doses of TD-4208 for 7 Days in Subjects Diagnosed With Chronic Obstructive Pulmonary Disease

Category Primary study
Registry of TrialsANZCTR
Year 2012
INTERVENTION: This study will evaluate the bronchodilatory effect, tolerability, and pharmacokinetics of multiple doses of TD‐4208 for 7 days in subjects with a clinical diagnosis of COPD. Each subject will receive four of six possible doses of TD‐4208 (22 micro g, 44 micro g, 88 micro g, 175 micro g, 350 micro g, or 700 micro g) and placebo once per day via a nebulizer over five 7‐day study periods in an incomplete crossover study design. Each period of treatment will be separated a washout period of 10 days up to a maximum of 16 days dependent on logistic considerations for the next dosing period. A final safety follow‐up assessment will be completed for all subjects 7 to 14 days after their last study treatment dose. CONDITION: Chronic Obstructive Pulmonary Disease (COPD) PRIMARY OUTCOME: Trough FEV1 is the mean of the 23 and 24 hour FEV1 measured by a maximal exhalation into a spirometer after the seventh dose of each treatment period. This assesses the effectiveness and duration of the bronchial dilatation. SECONDARY OUTCOME: Blood Pressure will be recorded using a sphygmomanometer or an automated blood pressure recorder. Cmax is the maximum plasma level of TD‐4208 the study drug measured from a blood sample. Heart rate which will be measured by palpation of the radial artery or by an automated heart rate recorder. Plasma half life is a calculation of the time taken for the plasma level of TD‐4208 the study drug measured from a blood sample to be eliminated from the body. QTcF which is a standardized ECG interval will be measured using an ECG machine. Tmax is the time taken to reach the maximum plasma level of TD‐4208 the study drug and is measured from the timed blood sample draws. INCLUSION CRITERIA: 1.Subject is a male or female between the ages of 40 and 75 years (inclusive, at randomization). 2.Subject has an FEV1/FVC <0.7 at screening; and has a post‐bronchodilator FEV1 at screening of between 30% and 80% (inclusive) of the predicted normal value. 3.Subject demonstrates at screening at least a 120 mL increase in FEV1 within 1 hour of receiving 500 microgram of ipratropium bromide from a PARI LC Sprint 'Registered Trademark' Nebulizer. 4.Females of non‐childbearing potential. All male subjects must agree to use a highly effective method of birth control with partners of childbearing potential during the study and for 1 month after completion of study dosing. 5.Subject (or care giver) is able to properly prepare and administer study medication. 6.Subject is willing and able to give written informed consent to participate.
Epistemonikos ID: 3dd13adc9fee4a04c3a6b93ff1ae38bf92769469
First added on: Aug 25, 2024