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.
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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
Full 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
Enrollment
Sex
Ages
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
700 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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