CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 33 enrolled
Drug / intervention
Formoterol plus Placebo (Tiotropium) +1 moredrug
Likely dose
Formoterol plus Placebo (Tiotropium) 12mcgfrom 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/NCT00680056
NCT00680056Phase 4Completed
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Randomised Cross-over Study to Compare the Effect of Formoterol Plus Tiotropium Versus Formoterol Monotherapy on Breathlessness, Dynamic Hyperinflation and Exercise Tolerance in Moderate-to-severe Stable COPD Patients

Federal University of São Paulo·interventional·Posted May 19, 2008·Updated Jan 20, 2010

In Brief

A Phase 4 clinical trial evaluating Formoterol plus Placebo (Tiotropium) and Formoterol plus Tiotropium for Pulmonary Disease, Chronic Obstructive and 2 related conditions. Completed, enrolled 33 participants across 1 site.

Detailed Summary

The primary objective is to comparatively evaluate the isolated effects of a long-acting beta2-adrenergic (formoterol fumarate 12µg b.i.d. via Aeroliser) and combined with a long-acting anti-cholinergic (tiotropium bromide 18µg o.d via Handihaler) on breathlessness, dynamic hyperinflation and exercise tolerance in patients with advanced, but stable, chronic obstructive pulmonary disease. The study hypothesis is that combining long acting bronchodilators with different action mechanisms would promote synergistic effects on clinical outcomes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive, Chronic Bronchitis, Pulmonary Emphysema
CountriesBrazil
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 19, 2008
Enrollment StartNov 1, 2007
Primary CompletionDec 1, 2008
Study CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 18.1 years ago

Interventions

Formoterol plus Placebo (Tiotropium)drug

Formoterol 12mcg-capsules (2x/d) + Placebo (Tiotropium) (1x/d). Double-blind medication will be dispensed in HandiHalers and Aerolisers during 2 weeks.

Formoterol plus Tiotropiumdrug

Formoterol 12mcg-capsule (2x/dia) + Tiotropium 18mcg-capsule (1x/d). Double-blind medication will be dispensed in HandiHalers and Aerolisers during 2 weeks.