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

Mahidol University

Status and phase

Completed

Phase 3

Conditions

Asthma

Treatments

Drug: Sereflo

Drug: Seretide

Study type

Interventional

Funder types

Other

Identifiers

si446/2010

Details and patient eligibility

About

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.

Enrollment

51 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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