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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kittipong Maneechotesuwan, Mahidol University
ClinicalTrials.gov Identifier:
NCT01274325
First received: January 7, 2011
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

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
Asthma
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

Resource links provided by NLM:


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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01274325

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

No publications provided

Responsible Party: Kittipong Maneechotesuwan, Professor, Mahidol University
ClinicalTrials.gov 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:
asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Anti-Inflammatory Agents
Fluticasone, salmeterol drug combination
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014