CONCEPT: A 1-Year Comparison Of A Stable Dose Of SERETIDE With An Adjustable Maintenance Dose Of SYMBICORT in Asthmatics
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.
Official Title
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
Conditions
Asthma
Study Type
Interventional
Study Design
Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Further Details
Primary Outcome Measures:
- Mean percentage of symptom-free days over a 52-week treatment period
Secondary Outcome Measures:
- 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)
Study Start
November 2002
Eligibility & Criteria
- Ages Eligible for Study: 18 Years – 70 Years
- Genders Eligible for Study: Both
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
Total Enrolment
700
Contact Details
Australian Locations:
- Toorak Gardens, SA5065, Australia
- Balmain, New South Wales, NSW2041, Australia
- Inala, Queensland, QLD4077, Australia
- Kippa Ring, Queensland, QLD4021, Australia
Published Results in Respiratory Research
Dates
Tags
Created by: