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: Completed
• Trial end date: 2004-07-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Budesonide; Fluticasone; Formoterol Fumarate; Salmeterol Xinafoate; Xhance

Criteria

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