Fulfil Patient population
How many patients were included in the Fulfil trial?
1,810
The impact study was a 52-week study that included over 10,000 patients. What were the 3 treatment arms of the study?
Trelegy, Breo, Anoro
What was the length of the Fulfil Trial
24 weeks...with a 28 week extension.
What was the difference in improvement of Trough FEV1 of Trelegy vs. Symbicort in Fulfil?
171ml (142ml for Trelegy and -29 for Symbicort)
What year was Symbicort approved in the U.S.
2007
What was the main criteria for exclusion in the Fulfil trial?
Current diagnosis of asthma.
(Another exclusion point was unresolved exacerbation or pneumonia)
What was the primary endpoint of the Impact Trial?
Annual rate of moderate or severe exacerbations during treatment.
What were the treatment arms in the FulFil trial?
Twice-daily Symbicort Turbuhaler
Trelegy demonstrated _______ rates of lung function improvement, quality of life scores, and exacerbations at 52 weeks compared to 24 weeks.
Consistent/similar
What was the initial marketing slogan for Symbicort?
"A reassuring sense of control"
Less than ___% of patients continued on to the extension portion of the Fulfil study.
25% (actual percentage was 23.7%)
The Patient population in the Impact trial included patients that were 40 years of age or older with a smoking history, moderate to very severe airflow limitation, a history of exacerbations within the last year, a CAT score greater than 10 (symptomatic), and an existing COPD regimen of 1-3 agents prior to the study. What patients were excluded from the trial?
Subjects with a current diagnosis of asthma.
How long was the run-in period for the FulFil trial? What treatment were patients on?
Two-week run in period.
Patients maintained current medication for COPD.
In the 1,810 patients in the ITT population, Trelegy had a ____ rate of pneumonia compared to Symbicort at 24 weeks. In the 430 patients that were a part of the 28 week extension, pneumonia rates were ____ between the treatment groups.
Higher.
Similar or consistent.
In aerosphere technology, what is each drug crystal bound to?
Synthetic phospholipid
Patients had to have moderate to very severe airflow limitation to be included in the Fulfil trial. What was the inclusion criteria with regard to exacerbations?
2 or more moderate exacerbations OR 1 or more severe exacerbations within the last year.
The run-in period of the Impact Trial was two weeks in length. During that period, patients were allowed to continue their own medication. What was the significance of this with regard to the outcome of the trial?
40% of patients were receiving triple therapy and more than 70% were on an ICS...meaning ICS was abruptly withdrawn in many patients randomized in the LABA + LAMA group...which could have resulted in a rapid surge of exacerbations in the first month in the Anoro arm.
In addition to the SGRQ improvement, what was the other co-primary endpoint of Fulfil?
Trough FEV1 @ week 24.
What potentially caused lung volumes to dip for patients in the Symbicort arm during the Fulfil trial?
1/3 of patients were on open triple and stepped down to ICS/LABA therapy (Symbicort)
What does ATS stand for?
American Thoracic Society
What was the age and smoking requirements to be included in the Fulfil trial?
40+ years and current or former smokers with 10 pack year history.
There was a high incidence of pneumonia in what treatment arms of the trial?
The ICS groups (Trelegy and Breo)
Furthermore, Trelegy had a significantly higher risk of clinician-diagnosed pneumonia vs Anoro, as assessed in a time-to-first-event analysis.
What was the key secondary endpoint of the Fulfil Trial?
Incidence of moderate or severe exacerbations over 24 weeks.
What was the incidence of Exacerbations over 24 weeks for patients in the Trelegy arm?
10% (N=95)
What does SGRQ stand for?
St. George Respiratory Questionnaire