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.

Randomised, Double-blind, Double-dummy, 52-week, Parallel Group Study of a Standard Dosing Regimen With Salmeterol/Fluticasone propionate50/250 Twice Daily Diskus Versus a Symptom-driven, Variable Dosing Regimen With Formoterol/Budesonide Combination 4.5/160 in Adult Asthmatics

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00479739

Enrollment

700

Registered

2007-05-28

Start date

2002-11-30

Completion date

2004-07-31

Last updated

2016-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

formoterol/budesonide, exacerbations, Salmeterol/fluticasone propionate, adjustable maintenance dosing, asthma control

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

Interventions

DRUGSalmeterol/fluticasone propionate or formoterol/budesonide

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

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

Design outcomes

Primary

Measure	Time frame
Mean percentage of symptom-free days over a 52-week treatment period	—

Secondary

Measure	Time frame
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)	—

Countries

Australia, Austria, Belgium, Bulgaria, Canada, Estonia, Finland, Germany, Ireland, Latvia, Netherlands, New Zealand, North Macedonia, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026