Comparison of Anti-inflammatory Effects of Seroflo and Seretide in Patients With Asthma

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to test hypothesis if Sereflo (ICS/LABA) could reduce airway inflammation in asthmatic patients in the same as Seretide.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mahidol University
• Treatments: Anti-Inflammatory Agents; Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Fluticasone-Salmeterol Drug Combination

Criteria

Inclusion Criteria:

• Age between 20-80 years

• Patients with asthma diagnosed by according to the American Thoracic Society criteria

• A baseline FEV1 > or = 50% predicted with a reversibility of FEV1 after therapy with inhaled salbuterol (2.5 mg) of FEV1 12% or with provocative concentration of a methacholine causing a 20% fall in FEV1 (PC20) of < or = 8 mg/mL

• Prescribed use of inhaled corticosteroids (any brand) for at least 12 weeks prior to study entry

• The daily prescribed dose of inhaled corticosteroids during the last 4 weeks prior to study entry should have been constant and at least 250 μg/day of fluticasone at least 400 μg/day of budesonide at least 500 μg/day of any other beclomethasone

• Be able to provide written informed consent

Exclusion Criteria:

• Any asthma exacerbation or respiratory tract infection affecting asthma within 4 weeks prior to the randomization visit

• Intake of oral, parenteral corticosteroids within 4 weeks and/or depot parenteral corticosteroid within 12 weeks prior to the randomization visits

• Current or previous smoker with a smoking history of > or = 10 pack years

• Previous randomization of treatment in the present study

• Known or suspected hypersensitivity to study therapy

• Use of any β-blocking agent, including eye-drops

• Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive pill measures