CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 457 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.

Search/NCT00523991
NCT00523991Phase 4Completed

A 24 Week, Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of 18 MCG of Tiotropium Inhalation Capsules Administered by HandiHaler Once-daily Plus PRN Albuterol (Salbutamol) vs. Placebo Plus PRN Albuterol (Salbutamol) in Chronic Obstructive Pulmonary Disease Subjects Naive to Maintenance Therapy

Boehringer Ingelheim·interventional·Posted Sep 3, 2007·Updated May 20, 2014

In Brief

A Phase 4 clinical trial evaluating tiotropium and Placebo for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 457 participants across 62 sites in 10 countries.

Detailed Summary

A 24 week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 18mcg of tiotropium inhalation capsules administered by Handihaler once daily plus Pro Re Nata (PRN) albuterol (salbutamol) vs. placebo plus PRN albuterol (salbutamol) in chronic obstructive pulmonary disease subjects naive to maintenance therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Canada, Czechia, Germany, Greece, Netherlands, Portugal, Ukraine, United Kingdom, United States
CollaboratorsPfizer

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 3, 2007
Enrollment StartApr 1, 2007
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 18.8 years ago

Interventions

tiotropiumdrug

Oral inhalation once daily of 18mcg tiotropium via handihaler

Placebodrug

Oral inhalation once daily of placebo matching tiotropium via handihaler