Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Phase IIa, Open-Label, Repeat-Dose Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Fixed Dose Combination Administered Twice-Daily by Inhalation in Chinese Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
A Phase IIa, open-label, repeat-dose trial to investigate the pharmacokinetics (PK), safety and tolerability of single and multiple twice daily doses of inhaled Aclidinium Bromide/Formoterol Fumarate 400/12 μg in 20 Chinese male and female patients with stable moderate to severe COPD.
Screening will be performed within 21 days of dosing on Day 1 at visit 2. Eligible
participants will be admitted to the trial center the day preceding the first dosing (day
-1).
Participants will receive Aclidinium Bromide/Formoterol Fumarate 400/12 μg twice-daily
(morning and evening) on Days 1 to 4. On Day 5 patients will receive the morning dose only.
PK and safety assessments will be conducted at specific timepoints on Day 1 to Day 7.
Participants will be discharged 48 h after the last administration of investigational product
and completion of the 48-h PK sample collection and safety assessments on Day 7.
A follow-up visit will be performed within 5 days of the last PK sample collection on Day 7.
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