PATIENTS IN YEAR-LONG INTERNATIONAL ASTHMA STUDY ABLE TO LIVE VIRTUALLY SYMPTOM FREE
GOAL Study investigators use most stringent measures ever
MISSISSAUGA, Ontario – October 15, 2004 – More than 40 per cent of patients with asthma in an international, first of its kind study - the Gaining Optimal Asthma controL (GOAL) Study™ - published today in the American Journal of Respiratory and Critical Care Medicine, were able to achieve ‘total control’ of their symptoms within the one-year study period. Total control was defined by the study investigators as the absence of asthma symptoms, including: no day-time symptoms; no night-time awakening; no exacerbations; no use of ‘rescue’ medications; near normal lung function; no emergency room visits; and no adverse events leading to a prescription change, for seven out of the eight week assessment period. With regular, sustained treatment, many study participants had better control of their asthma, as defined by the study.
The one-year GOAL study demonstrated that 41 per cent of the GOAL patients treated with the asthma medication, Advair® (salmeterol xinafoate/fluticasone propionate), instead of an inhaled corticosteroid alone (fluticasone propionate), attained and maintained the stringent study criteria for total control. Further, by aiming for total control, 71 per cent of patients using Advair® achieved well-controlled asthma, which was the primary study measure.
“During the trial, we saw many asthma patients who were able to live virtually free of their symptoms – a result that exceeded even our initial expectations,” said Dr. Robert Cowie, a Canadian GOAL Investigator and Professor of Medicine at the University of Calgary, Alberta. “The one-year GOAL Study showed us that regular, sustained use of Advair, at the appropriate dose, can help many patients with asthma to improve their symptom control.”
More than three million Canadians currently live with asthma.i Close to six in 10 Canadians with asthma do not have control of their disease and are leading a life compromised by symptoms.ii They have accepted a substandard quality of life, enduring regular night-time awakening or missing out on physical activity or social or family events.
“I accepted that having asthma meant that I missed out on certain things, including walks with my husband and bicycling,” said Laura Hiner, GOAL Study participant and asthma patient. “Being involved in the GOAL study proved to me that my asthma symptoms can be controlled and that I can live an active life.”
Defining Control
GOAL defined two levels of asthma control: well-controlled asthma
(the primary goal), and the more stringent definition of total control.
Both levels of control were measured by reviewing a number of factors, or
endpoints, used to evaluate overall treatment effectiveness.
The definition of total control used in the trial is the most rigorous used in any asthma trial to date and, to achieve total control, patients had to achieve and sustain that level of control for at least seven weeks out of an eight-week assessment period within the one year study. Total control was defined as the absence of asthma symptoms, including: no day-time symptoms; no night-time awakening; no exacerbations; no use of ‘rescue’ medications; near normal lung function; no emergency room visits; and no adverse events leading to a prescription change. Well-controlled asthma was similarly assessed over eight weeks but allowed a low level of symptoms and rescue medication use.
About GOAL
The one-year GOAL trial was a stratified, randomized, double-blind,
parallel-group trial of more than 3,000 patients from 44 countries around
the world, including 16 sites in Canada. It is the first study ever
to assess whether guideline-defined asthma control is clinically
realistic.
The primary objective of the study was to determine the proportion of subjects who achieved well-controlled asthma with Advair compared with an inhaled corticosteroid (ICS) alone during Phase I. GOAL also measured what proportion of adult and adolescent patients (from 12 to 80 years of age) could achieve total asthma control with salmeterol xinafoate/fluticasone propionate combination (Advair) or fluticasone propionate alone.
Treatment was stepped up every 12 weeks until either total control was achieved or the maximum dose of inhaled corticosteroid was reached. This phase was followed by a constant dose phase for a total double-blind period of 52 weeks to assess if control could be maintained over time, and if there was incremental benefit. Control was assessed over the last eight weeks in each twelve-week step-up period.
Study results show more patients taking Advair achieved total control than those taking an inhaled corticosteroid (fluticasone propionate) alone (41 per cent versus 28 per cent). In addition, this level of control was achieved significantly faster, and with a lower dose of inhaled corticosteroids with Advair, than with inhaled corticosteroids only.
“GOAL demonstrates that we, as healthcare providers, must encourage patients to achieve much better control of their asthma,” said Dr. Cowie.
Asthma in Canada
Approximately three million Canadians are living with asthma, a chronic
lung disease resulting in recurrent attacks of breathlessness, and
generally accompanied by wheezing, chest tightening and/or coughing.
Asthma is characterized by both inflammation of the airways of the lungs
and constriction of the muscles surrounding the airways. According
to the World Health Organization, asthma is now a serious public health
problem with more than 300 million sufferers worldwide.i
About ADVAIR
ADVAIR® (salmeterol xinafoate/fluticasone propionate) is
available in two dosage forms, ADVAIR® DISKUS® for
patients four years and older and ADVAIR® MDI® for
patients 12 years and older. ADVAIR is indicated for the maintenance
treatment of asthma in patients with reversible obstructive airways
disease where the use of a combination product is considered to be
appropriate. The most common side effects patients experience
include dysphonia (hoarseness), throat irritation, headache and thrush.
About GlaxoSmithKline Inc.
GlaxoSmithKline Inc. – one of the world’s leading research-based
pharmaceutical and health-care companies – is committed to improving the
quality of human life by enabling people to do more, feel better and live
longer. In Canada, GlaxoSmithKline is a top 20 investor in Canadian
research and development, contributing more than $100 million annually.
The company is also among the top 10 corporate charitable donors and is
recognized as one of the 50 best companies to work for in Canada.
Medical experts are available in Calgary, Toronto, Ottawa and Montreal. Patients are available in Kelowna, Calgary and Toronto.
Additional information, as well as the full study results, are available at www.goalstudy.com.
For more information, or to arrange an interview, please contact:
Laura Pagnotta / Fiona
Buchanan
Cathy Metson / Alison Steeves
NATIONAL PharmaCom
GlaxoSmithKline Inc.
Tel.: 416-586-0180
Tel.: 905-819-3363
