CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Aclidinium Bromide/Formoterol Fumarate 400/12μg BIDdrug
Likely dose
Aclidinium Bromide/Formoterol Fumarate 400/12μg BIDfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03276078
NCT03276078Phase 2Completed
CompareCT.gov

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

AstraZeneca·interventional·Posted Sep 8, 2017·Updated Jul 22, 2019

In Brief

A Phase 2 clinical trial evaluating Aclidinium Bromide/Formoterol Fumarate 400/12μg BID for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 20 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesChina
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedSep 8, 2017
Enrollment StartNov 23, 2017
Primary CompletionJun 12, 2018
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 8.8 years ago

Interventions

Aclidinium Bromide/Formoterol Fumarate 400/12μg BIDdrug

Aclidinium bromide/formoterol fumarate 400/12μg administered by inhalation via the Genuair® multidose dry powder inhaler, twice daily (morning and evening) for 5 days