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CONCEPT: A 1-Year Comparison Of A Stable Dose Of SERETIDE With An Adjustable Maintenance Dose Of SYMBICORT in Asthmatics

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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

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Dates

Posted On: 1 January, 2013
Modified On: 16 September, 2014

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