CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 221 enrolled
Drug / intervention
Salmeterol/Fluticasone 50/250 mcg +2 moredrug
Likely dose
Salmeterol/Fluticasone 50/250 mcgfrom 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/NCT00363480
NCT00363480Phase 4Completed

Asthma Control Assessment Via ACT and DRC in Asthmatics Treated With Seretide (50/250) Over 12 Weeks

GlaxoSmithKline·interventional·Posted Aug 15, 2006·Updated Mar 9, 2018

In Brief

A Phase 4 clinical trial evaluating Salmeterol/Fluticasone 50/250 mcg, Salbutamol 100 mcg, and 1 other intervention for Asthma. Completed, enrolled 221 participants across 32 sites.

Detailed Summary

The majority of asthma patients are not well controlled, despite the availability of asthma medication that could effectively treat the disease. In this study uncontrolled patients who are steroid-naive or on low dose inhaled corticosteroids will be treated with Seretide (salmeterol/fluticasone combination, SFC) 50/250 µg twice daily. The asthma control test (ACT) will be used to detect differences in the level of asthma control during treatment. The study aims to show a correlation between improvements of ACT und the level of asthma control which will be reached by the patients. The aim of the study is to show that most of symptomatic asthma patients can reach 'well controlled asthma' with SFC. We get information about ACT in daily practice and physicians are trained to use the asthma control test as a screening tool and for follow up of asthma management. Correlations are expected between the improvements in ACT, Quality of Life and asthma control according to the Gaining Optimal Asthma controL (GOAL) criteria.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesGermany
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 15, 2006
Enrollment StartMay 17, 2006
Primary CompletionSep 1, 2007
Study CompletionSep 14, 2007
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 19.9 years ago

Interventions

Salmeterol/Fluticasone 50/250 mcgdrug

Participant received salmeterol/fluticasone combination 50/250 mcg using DISKUS™ powder inhalers.

Salbutamol 100 mcgdrug

This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol.

DISKUS™ powder inhalersdevice

Participant received salmeterol and fluticasone using DISKUS™ powder inhalers.