SERETIDE 100/50 bd (Twice Daily) Versus FLIXOTIDE 100 bd As Initial Maintenance Therapy In Moderate Asthma In Adults

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-12-31

Brief Summary

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This study will compare during 12 weeks, two treatment strategies for Initial Maintenance Therapy : fluticasone propionate alone or the salmeterol/fluticasone propionate combination in adults with moderate persistent asthma

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Detailed Description

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A multicentre randomised, double-blind, parallel-group study to compare the salmeterol/fluticasone propionate combination (SERETIDETM DISKUSTM 50/100) 50/100µg one inhalation twice daily with fluticasone propionate (FLIXOTIDETM DISKUSTM 100) 100µg one inhalation twice daily as initial maintenance therapy for 12 weeks in adults with persistent moderate asthma

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Salmeterol xinafoate/fluticasone propionate combination

SFC 100

Intervention Type DRUG

Fluticasone propionate

FP 100

Intervention Type DRUG

Other Intervention Names

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SERETIDE FLIXOTIDE

Eligibility Criteria

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Inclusion Criteria

* male or female ≥ 18
* documented history of asthma
* reversibility FEV1 or PEF ≥ 12% (post 400µg salbu)
* moderate asthma (daily symptoms, daily rescue use, PEF = 60-80% predicted value)
* naive or ≥ 4weeks-free ICS (inhaled corticosteroids)

Exclusion Criteria

* respiratory disorder
* FEV1\<60% predicted
* exacerbation/respiratory infection ≤ 4 weeks
* oral/parenteral/depot corticosteroids ≤ 6 months
* LABA/oral β2 agonist/ ALT/ theophylline ≤ 4 weeks
* smoker or former smoker ≥ 5 packs year

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No