Clinical trial · Interventional

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

Seretide 100 DK vs Flixotide 100 DK in IMT in Moderate Asthma in Adults on Static Lung Volumes (Mechanistic Study)

NCT00461500CI-TRIAL-00026255completedPhase 4Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Asthma	—	UNRESOLVED	—

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Fluticasone propionate	Drug	—	UNRESOLVED
Salmeterol xinafoate/fluticasone propionate combination	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) Over Weeks 5-12
timeFrame
Baseline, Weeks 5-12
description
Mini Wright Peak Flow Meter used to allow patients to monitor their asthma - Peak Flow (or PEF - peak expiratory flow) is a measurement of how fast you can blow out. When someone is well, their PEF is higher - when the airways are narrow (as in asthma), PEF is lower. Readings based on age, height and gender.

Secondary outcomes (12)

measure
Change From Baseline in Pre-dose FEV1 (Forced Expiratory Volume in One Second) Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)
timeFrame
Baseline through Week 12
description
FEV1 is the amount of air (in liters) you can blow out within one second. A spirometer is the device used to measure FEV1. With normal lungs and airways you can normally blow out most of the air from your lungs within one second. Age, height and gender is used to determine what is normal. Change from baseline could have been measured at any time during the study (up to Week 12), using the LOCF. In the LOCF approach, for each individual, missing values are replaced by the last observed value of that variable.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 40 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.