Back to results

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

Primary Purpose

Asthma

Status

Completed

Phase

Phase 3

Locations

Thailand

Study Type

Interventional

Intervention

Sereflo

Seretide

About this trial

This is an interventional treatment trial for Asthma focused on measuring asthma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Kittipong Maneechotesuwan
Division of Respiratory Disease and TB, Siriraj Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sereflo

Seretide

Arm Description

Sereflo (25/125)

Seretide (25/125)

Outcomes

Primary Outcome Measures

Sputum eosinophils

Secondary Outcome Measures

Exhaled nitric oxide

Asthma control test scores

Full Information

NCT ID

NCT01274325

First Posted

January 7, 2011

Last Updated

September 9, 2013

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT01274325

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mahidol University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sereflo

Arm Type

Experimental

Arm Description

Sereflo (25/125)

Arm Title

Seretide

Arm Type

Active Comparator

Arm Description

Seretide (25/125)

Intervention Type

Drug

Intervention Name(s)

Sereflo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Seretide

Intervention Description

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

Primary Outcome Measure Information:

Title

Sputum eosinophils

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Exhaled nitric oxide

Time Frame

4 weeks

Title

Asthma control test scores

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kittipong Maneechotesuwan, MD., PhD.

Organizational Affiliation

Faculty of Medicine Siriraj Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kittipong Maneechotesuwan

City

Bangkoknoi

State/Province

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

Division of Respiratory Disease and TB, Siriraj Hospital

City

Bangkoknoi

State/Province

BKK

ZIP/Postal Code

10700

Country

Thailand

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs