Skip to main content
OpenTrials
Completed

NCT Number: NCT01274325

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Division of Respiratory Disease and TB, Siriraj Hospital, Bangkoknoi, BKK, Thailand

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sereflo

Drug

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

Seretide

Drug

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

Primary outcomes

  1. Sputum eosinophils

    Time frame: 4 weeks

Secondary outcomes

  1. Exhaled nitric oxide

    Time frame: 4 weeks

  2. Asthma control test scores

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 11, 2011
Registry last updated
Sep 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.