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

NCT ID: NCT01274325

Last Updated: 2013-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Keywords

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asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sereflo

Sereflo (25/125)

Group Type EXPERIMENTAL

Sereflo

Intervention Type DRUG

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

Seretide

Seretide (25/125)

Group Type ACTIVE_COMPARATOR

Seretide

Intervention Type DRUG

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

Interventions

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Sereflo

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

Intervention Type DRUG

Seretide

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Kittipong Maneechotesuwan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kittipong Maneechotesuwan, MD., PhD.

Role: PRINCIPAL_INVESTIGATOR

Siriraj Hospital

Locations

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Kittipong Maneechotesuwan

Bangkoknoi, Bangkok, Thailand

Site Status

Division of Respiratory Disease and TB, Siriraj Hospital

Bangkoknoi, BKK, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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si446/2010

Identifier Type: -

Identifier Source: org_study_id