This study was stratified, parallel, double blind, multicentred and randomised.
The GOAL study's primary objective is to find out the proportion of asmathic patients who could achieve well control over their asmathic condition using Sere.tide, as opposed to Fluticasone Propionate (FP) monotherapy.
Secondary objectives of this study include:
-- The determination of proportion of patients who could achieve TOTAL CONTROL.
-- To determine the dose needed to achieve well control over asthma.
This study was conducted in over 300 centres all over 44 countries.
The minimum required age for participants in this study was 12 years old
Participants needed to have a reversibility FEV1 of at least 15% to ensure that the patients were REALLY asthmatic, and not feigning their circumstance. Patients also had to be steroid naive throughout their whole asthmatic life, or have been on a steady dose of ICS for the past 6 months.
Participant categories were divided into 3 stratas. Of which included:
-- Strata 1: Steroid naive
-- Strata 2: Less than or 500 micrograms of beclometasone or eq
-- Strata 3: Between 500-1000 micrograms of beclometasone or eq
The run-in period before randomisation of this study was 4 weeks.
Participants who were excluded from this study included long term smokers, pregnant women and breast feeding mothers.
GINA- Global INitiative for Asthma has 7 criterias to define asthma control
-- No side effects of medication taken
-- No emergency visits to the hospital due to asthma attacks
-- Minimal need for rescue medication/reliever
-- No exacerbations in any week
-- Near normal lung function
-- No asthma attacks
-- No day/night time symptoms
The difference between Well controlled asthma and TOTAL CONTROL of asthma is that there is leeway for day/night time symptoms in any week to be classified as well controlled, where as TOTAL control does not offer any leeway for symptoms/attacks.
The important point derived from the results of the study in accordance to the primary objective was that MORE patients on Sere.tide achieved well control compared to patients on FP monotherapy
Less steroid dosage was needed to achieve control as compared to patients on FP monotherapy
Patients on Sere.tide achieve well control faster than patients who were on FP monotherapy
The GOLD standard has shown that Sere.tide is significantly (p<0.001)>
Sere.tide has a Promise campaign that fights for TOTAL CONTROL as the main objective of asthma management. Also, that Sere.tide should be the first line indication for all cases of asthma as opposed to ICS monotherapy because there is a significantly better chance to achieve TOTAL CONTROL.
Quality of Life was reported to be "normal" and better by patients who were taking Sere.tide. Mean scores of the QoLQ increased from a 4.5 at baseline to >6 by the end of the study. Over 60% of patients on Sere.tide reported better QoL.
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