We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01274325
Recruitment Status : Completed
First Posted : January 11, 2011
Last Update Posted : September 11, 2013
Information provided by (Responsible Party):
Kittipong Maneechotesuwan, Mahidol University

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Sereflo Drug: Seretide Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : February 2011
Primary Completion Date : April 2013
Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Sputum eosinophils [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Exhaled nitric oxide [ Time Frame: 4 weeks ]
  2. Asthma control test scores [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Kittipong Maneechotesuwan, Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT01274325     History of Changes
Other Study ID Numbers: si446/2010
First Posted: January 11, 2011    Key Record Dates
Last Update Posted: September 11, 2013
Last Verified: September 2013

Keywords provided by Kittipong Maneechotesuwan, 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