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

Comparison of Anti-inflammatory Effects of Seroflo 125 Inhaler With Seretide Evohaler(25/125) in Patients With Asthma

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01274325

Enrollment

Registered

2011-01-11

Start date

2011-02-28

Completion date

2013-07-31

Last updated

2013-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

asthma

Brief 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.

Interventions

DRUGSereflo

Patients take sereflo (25/125) 2 puffs twice a day for 4 weeks

DRUGSeretide

Patients will take Seretide (25/125) 2 puffs twice a day for 4 weeks

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Sputum eosinophils	4 weeks

Secondary

Measure	Time frame
Exhaled nitric oxide	4 weeks
Asthma control test scores	4 weeks

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026