CONCEPT: A 1-Year Comparison Of A Stable Dose Of SERETIDE® Inhaler With An Adjustable Maintenance Dose Of SYMBICORT® Inhaler. SERETIDE® Inhaler is a Trademark of GSK Group of Companies. SYMBICORT® Inhaler is a Trademark of Astra Zeneca.

Phase 4

Completed

• Conditions: Asthma
• Interventions: Drug: Salmeterol/fluticasone propionate or formoterol/budesonide

• Registration Number: NCT00479739
• Lead Sponsor: GlaxoSmithKline

Brief Summary

To compare a stable dose of salmeterol/fluticasone propionate with a variable dose of formoterol/budesonide where the dose is adjusted according to a physician-guided self-management plan

Detailed Description

A randomised, double-blind, double-dummy, 52-week, parallel group study of a standard dosing regimen with salmeterol/fluticasone propionate combination 50/250mcg bid (via the DISKUS/ACCUHALER inhaler) versus a symptom-driven variable dosing regimen with formoterol/budesonide combination 6/200mcg (via a breath-actuated dry powder reservoir inhaler)in adults asthmatics

Study Timeline

• Study Start: 2002-11
• Primary Completion: 2004-07
• Study Completion: 2004-07
• Study First Submitted: 2007-05-25
• Study First Submitted QC: 2007-05-25
• Study First Posted: 2007-05-28
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-13
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

• Documented clinical history of asthma
• Forced expiratory volume in 1 second between 60% and 90% of predicted
• Using an inhaled corticosteroid (ICS)at a dose equivalent to 200 to 500 mcg daily of beclomethasone (BDP)or equivalent combined with a long-acting beta-2-agonist or an ICS alone at a dose equivalent to >500 to 1000mcg daily of BDP daily

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Exclusion Criteria

• Lower respiratory tract infection within 1 month of study entry
• Use of systemic corticosteroids within 1 month of study entry
• Smoking history of 10 pack years or more Changes in regular asthma therapy within 12 weeks of study entry
• Any significant disorder that in the investigator's opinion might put the patient at risk or influence the study outcomes

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Salmeterol/fluticasone propionate or formoterol/budesonide	-

Primary Outcome Measures

Name	Time	Method
Mean percentage of symptom-free days over a 52-week treatment period

Secondary Outcome Measures

Name	Time	Method
Mean percentage of rescue-free days Daily asthma symptom scores Daily rescue usage Mean morning peak flow Percentage of nights awoken due to asthma Rate of exacerbations Airway hyper-responsiveness(PC20 AMP)

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 Fleetwood, United Kingdom