CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 56 enrolled
Drug / intervention
ADOAIR250 +1 moredrug
Likely dose
ADOAIR250 250 mcgfrom 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/NCT01607398
NCT01607398Phase 4Completed
CompareCT.gov

A 12-week Randomised, Double-blind, Parallel-group Study to Evaluate the Anti-inflammatory Effects of ADOAIR® 50/250mcg Twice Daily Compared With Placebo Twice Daily in Japanese Subjects With Chronic Obstructive Pulmonary Disease (COPD)

GlaxoSmithKline·interventional·Posted May 30, 2012·Updated May 26, 2014

In Brief

A Phase 4 clinical trial evaluating ADOAIR250 and Placebo for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 56 participants across 3 sites.

Detailed Summary

The study will be conducted in a respiratory specialist institute in Japan, with standardized techniques and data assurance checks to optimize data quality. The licensed dosage and administration of Adoair in Japan will be applied in this study. Each subject will receive treatment options in a randomized blinded fashion. Subjects will be randomized following a 4-week wash-out phase to take either Adoair 50/250mcg twice daily or placebo twice daily for 12 weeks.

Study Details

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

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 30, 2012
Enrollment StartMay 1, 2012
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 14.1 years ago

Interventions

ADOAIR250drug

250 mcg inhalation, twice daily, from week0 -12.

Placebodrug

Placebo inhalation, twice daily, from week0 -12.