At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 140 enrolled
Drug / intervention
tiotropium +1 moredrug
Likely dose
tiotropium 18mcgfrom 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 12-week, Randomised, Placebo-controlled, Double-blind, Parallel Group, Multi-center Trial to Assess the Efficacy and Safety of Tiotropium Bromide (18 µg) Delivered Via the HandiHaler® in Patients With Newly Diagnosed and/or Maintenance Treatment naïve Chronic Obstructive Pulmonary Disease (COPD) Experiencing an Acute Respiratory Infection (TICARI 1: Tiotropium In COPD Patients With an Acute Respiratory Infection 1)
In Brief
A Phase 4 clinical trial evaluating tiotropium and Placebo for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 140 participants across 27 sites.
Detailed Summary
The aim of the study is to investigate whether the early introduction of maintenance bronchodilator therapy during an acute symptomatic episode of the disease shows benefits on the recovery of symptoms. It also represents an opportunity to identify COPD patients earlier in their disease state and start maintenance therapy, if appropriate.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2011
First PostedDec 2011
Primary CompletionDec 2012
TodayJul 2026
First PostedDec 1, 2011
Enrollment StartNov 1, 2011
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 14.6 years ago
Interventions
tiotropiumdrug
18mcg
Placebodrug
placebo