Symbicort Offers Major Quality-of-Life Improvements Over Inhaled Steroids or Formoterol Alone: Presented at ERS

By Cameron Johnston

COPENHAGEN, DENMARK -- September 23, 2005 -- Patients with severe chronic obstructive pulmonary disease (COPD) and long histories of smoking have meaningful and significant improvements in quality of life when they are switched from long-acting beta agonists (LABAs) or inhaled corticosteroids (ICS) to the combination therapy budesonide/formoterol (Symbicort).

Other studies to data have shown significant quality-of-life improvements when Symbicort combination therapy was compared to placebo, but a study done in Montreal, Quebec, Canada, is believed to be the first to measure the quality-of-life impact of the combination against each of its constituent parts.

Researchers presented the findings of this study here on September 22nd at the European Respiratory Society 15th Annual Congress (ERS).

In the study, 421 patients were recruited from 59 pulmonary centers around Canada. The subjects were receiving either a LABA or ICS at enrollment, but had not been treated with a combination therapy for at least 30 days before enrollment. Patients were treated with Symbicort 200 (budesonide/formoterol 200/6 mcg) twice daily for 6 months.

Quality of life was measured on the St. George Respiratory Questionnaire, a well-validated instrument that included 76 questions asked by an interviewer, covering 3 domains (symptoms, activities, and impact of COPD on the patient's health). Patients also were given a self-reported test that included 10 items in 3 domains (symptoms, functional state and mental state). A lower score indicates an improvement, and an improvement of -4 points is considered significant.

Patients were evaluated with each of the tests at 1, 3, and 6 months of follow-up. The mean changes in symptom scores recorded were at least -8 points at each of the time points. Mean changes in total SGRQ scores were -5.8 at month one, -7.1 at month 3, and -5.9 at month 6.

Activity scores were also significantly better than at baseline for each of the time points as well: month 1: -4.5; month 3: -6.6; and month 6: -5.1.

Scores reflecting the impact the COPD was having on the patient's overall health were similarly reduced: -5.8 at month 1; -6.6 at month 3; and -5.4 at month 6.

According to principal investigator, Jean Bourbeau, MD, director of the respiratory epidemiology and clinical research unit at the Montreal Chest Institute, McGill University Health Centre, Montreal, Quebec, Canada, it is important that these changes were seen early on in the treatment with Symbicort.

The changes in scores were all clinically and statistically significant and similar changes were recorded in previous randomized and controlled trials in which Symbicort was compared against a placebo, he said.

AstraZeneca, marketer of Symbicort, provided funding for this study.

[Presentation title: A Prospective Descriptive Trial Examining 421 Canadian COPD Patients. Poster 3360]

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