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

This study has been completed.
Information provided by (Responsible Party):
Kittipong Maneechotesuwan, Mahidol University Identifier:
First received: January 7, 2011
Last updated: September 9, 2013
Last verified: September 2013
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.

Condition Intervention Phase
Drug: Sereflo
Drug: Seretide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Anti-inflammatory Effects of Seroflo 125 Inhaler With Seretide Evohaler(25/125) in Patients With Asthma

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Sputum eosinophils [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Exhaled nitric oxide [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Asthma control test scores [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: February 2011
Study Completion Date: July 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sereflo
Sereflo (25/125)
Drug: Sereflo
Patients take sereflo (25/125) 2 puffs twice a day for 4 weeks
Active Comparator: Seretide
Seretide (25/125)
Drug: Seretide
Patients will take Seretide (25/125) 2 puffs twice a day for 4 weeks


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01274325

Kittipong Maneechotesuwan
Bangkoknoi, Bangkok, Thailand, 10700
Division of Respiratory Disease and TB, Siriraj Hospital
Bangkoknoi, BKK, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Principal Investigator: Kittipong Maneechotesuwan, MD., PhD. Faculty of Medicine Siriraj Hospital
  More Information

Responsible Party: Kittipong Maneechotesuwan, Professor, Mahidol University Identifier: NCT01274325     History of Changes
Other Study ID Numbers: si446/2010 
Study First Received: January 7, 2011
Last Updated: September 9, 2013
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics processed this record on October 28, 2016