At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 626 enrolled
Drug / intervention
Roflumilast +2 moredrug
Likely dose
Not stated in 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.
A 6-month, Double-blind, Randomised, Multicenter, Multinational Trial to Investigate the Effect of 500 µg Roflumilast Tablets Once Daily Versus Placebo on Pulmonary Function in Patients With COPD. The ACROSS Trial
In Brief
A Phase 3 clinical trial evaluating Roflumilast, Placebo, and 1 other intervention for COPD. Completed, enrolled 626 participants across 15 sites in 3 countries.
Detailed Summary
The aim of this trial is to determine the efficacy, safety and tolerability of 500 µg Roflumilast tablets once daily in patients with COPD in China, Hong Kong, and Singapore.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD
CountriesChina, Hong Kong, Singapore
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2011
First PostedMar 2011
Primary CompletionMay 2012
TodayJul 2026
First PostedMar 11, 2011
Enrollment StartMar 1, 2011
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 15.3 years ago
Interventions
Roflumilastdrug
Roflumilast tablets
Placebodrug
Placebo tablets
Salbutamoldrug
Salbutamol (given by MDI and spacer) used as rescue medication on an ass needed basis throughout the trial, and was used for post-bronchodilator spirometry tests at all study visits.