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

NCT01274325 | Completed Phase 3 DMC

• 1 other identifier: si446/2010
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

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.

Conditions

Asthma

Keywords

asthma

Outcome Measures

Primary Outcomes (1)

• Sputum eosinophils

  4 weeks

Secondary Outcomes (2)

• Exhaled nitric oxide

  4 weeks

• Asthma control test scores

  4 weeks

Study Arms (2)

Sereflo

EXPERIMENTAL

Sereflo (25/125)

Drug: Sereflo

Seretide

ACTIVE COMPARATOR

Seretide (25/125)

Drug: Seretide

Interventions

Sereflo DRUG

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

Sereflo

Seretide DRUG

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

Seretide

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (2)

Kittipong Maneechotesuwan

Bangkoknoi, Bangkok, 10700, Thailand

Location

Division of Respiratory Disease and TB, Siriraj Hospital

Bangkoknoi, BKK, 10700, Thailand

Location

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Kittipong Maneechotesuwan, MD., PhD.

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 7, 2011
• First Posted: January 11, 2011
• Study Start: February 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: July 1, 2013
• Last Updated: September 11, 2013

Record last verified: 2013-09

Locations

TH (2)