CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 342 enrolled
Drug / intervention
Tiotropium Bromide +1 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.

Search/NCT00784550
NCT00784550Phase 4Completed
CompareCT.gov

A Randomized, Double-Blind, Parallel-Group, 24-Week Study to Evaluate the Efficacy and Safety of ADVAIR DISKUS (Fluticasone Propionate/Salmeterol Combination Product 250/50mcg Inhalation Powder) BID Plus Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder 18mcg) QD Versus Spiriva QD Plus Placebo DISKUS BID in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

GlaxoSmithKline·interventional·Posted Nov 4, 2008·Updated Nov 23, 2016

In Brief

A Phase 4 clinical trial evaluating Tiotropium Bromide and Fluticasone Propionate/Salmeterol for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 342 participants across 35 sites.

Detailed Summary

The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) in patients with COPD. SPIRIVA® and HANDIHALER® are trade marks of Boehringer Ingelheim Pharma GmbH \& Co. KG. ADVAIR DISKUS® are registered trademarks of the GSK group of companies.

Study Details

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

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 4, 2008
Enrollment StartDec 1, 2008
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 17.7 years ago

Interventions

Tiotropium Bromidedrug

Long-acting muscarinic antagonist

Fluticasone Propionate/Salmeteroldrug

Inhaled corticosteroid plus long-acting bronchodilator