CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 31 enrolled
Drug / intervention
Symbicort® total dose 400ug/12ug +3 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/NCT01787097
NCT01787097Phase 4Completed

GR Activity in Induced Sputum Macrophages, and a Change in Inflammatory Biomarkers 2-hours After a Single Dose of Either Symbicort®/Budesonide/Formoterol or in Chronic Obstructive Pulmonary Disease (COPD)

Imperial College London·interventional·Posted Feb 8, 2013·Updated Nov 23, 2020

In Brief

A Phase 4 clinical trial evaluating Symbicort® total dose 400ug/12ug, Symbicort® total dose 800ug/24ug, and 2 other interventions for Chronic Obstructive Lung Disease. Completed, enrolled 31 participants across 1 site.

Detailed Summary

The purpose of the research (or "knowledge gap" this research is designed to fill) is to understand the science of how the combination therapy of 2 drugs (inhaled longacting beta-agonists(LABA) and inhaled corticosteroids (ICS), which are commonly used in chronic obstructive pulmonary disease (COPD) patients, is better than each drug alone. ICS and LABA both have antiinflammatory properties; that is, they dampen the inflammation in the cells of the airways in the lungs. The combination of LABA and ICS has also been shown to improve clinical effectiveness in asthma patients. The addition of a LABA to LOW doses of ICS has been shown to be more clinically beneficial in asthma than the use of HIGH doses of ICS alone. This has allowed a reduction in the total ICS dose and minimised the adverse side effects of inhaled corticosteroids. Recent evidence suggests that the use of combination therapy of LABA and ICS may also improve clinical effectiveness in COPD patients. Investigators will address this hypothesis by examining the inflammation cells of COPD direct from the site of disease (the airways) by looking at sputum/mucus. This research will build on the existing knowledge of the science of how these drugs work in asthma and COPD and allows us to understand the molecular science, which may support new future drug targets for patients with COPD, which are greatly needed.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
CollaboratorsAstraZeneca

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 8, 2013
Enrollment StartJan 1, 2013
Primary CompletionDec 1, 2014
Study CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 13.4 years ago

Interventions

Symbicort® total dose 400ug/12ugdrug

Symbicort® is combination of formoterol 400ug and budesonide 12ug. Single dose

Symbicort® total dose 800ug/24ugdrug

Symbicort® is combination of formoterol 800ug and budesonide 24ug. Single dose

Formoterol 24ugdrug

Turbuhaler

BUD total dose 800ugdrug

Turbuhaler