Asthma Facts
The highest asthma prevalence rates in the US are seen in these 2 groups.
Puerto Ricans and Blacks
What was the patient population?
Adults 18-75yo w/ MILD asthma.
-Use of SABA as sole therapy in previous 3 months & use of SABA on at least 2 occasions, but on average of two or fewer occasions per day in previous 4 weeks.
-No minimum requirement for SABA use on those w/ severe exacerbation in previous 12 months.
Definition of an open label trial
Information is not withheld from trial participants - both the researchers and participants know which treatment is being administered
This is the sample size of the study that underwent analysis.
668 patients
The 3 groups were essentially equally randomized.
This medication has bronchodilator activity in acute asthma, possibly due to inhibition of calcium influx into airway smooth muscle cells.
Magnesium Sulfate
2g IV over 20 mins as adjunctive therapy for severe life-threatening exacerbations and for exacerbations that remain severe after 1 hr of intensive conventional therapy.
Exclusion criteria for the study
Hospitalization for asthma in the previous 12 months and either a patient-reported smoking history of more than 20 pack-years or the onset of respiratory symptoms after the age of 40 years in current or previous smokers with a smoking history of at least 10 pack-years
What type of trial was this? Be specific.
Randomized, open-label, parallel-group, controlled trial.
This was an intention to treat study design.
This was anticipated dropout rate.
20%.
13 patients were lost to follow-up.
71 patients had treatment failure and were withdrawn.
Actual 'drop-out' rate 12.5%
During intubation, this neuromuscular blocking agent should be avoided due to its release of appreciable amounts of histamine.
Bonus: Name a commonly used option in asthmatics.
Avoid succinylcholine or atracurium.
Rocuronium preferred. Cisatracurium or vecuronium also options.
Identify the intervention/comparison.
1:1:1 ratio of the following:
-albuterol PRN
-budesonide maintenance + albuterol PRN
-budesonide-formoterol
This is the thing that becomes toast.
What is bread?
Primary Outcome of this study
Annualized rate of asthma exacerbations per patient.
It's useful to measure this frequently in asthmatics so that your patient knows his/her baseline.
Peak Expiratory Flow
DAILY DOUBLE
Brand names of budesonide AND budesonide/formoterol.
Budesonide is Pulmicort.
Budesonide/Formoterol is Symbicort.
Secondary Outcomes of this study (name 3)
number of exacerbations
time to the first exacerbation
number of severe exacerbations
number of patients who were withdrawn as a result of treatment failure
score on the Asthma Control Questionnaire–5
on-treatment forced expiratory volume in 1 second (FEV1)
fraction of exhaled nitric oxide
the electronically recorded daily dose of budesonide
oral prednisone use (in milligrams)
the electronically recorded number of β2-agonist actuations per day
adverse events
A peak expiratory flow decrease of ___% from baseline may indicate an exacerbation.
10-20%
These patients were withdrawn for treatment failure. Name all scenarios.
1 severe exacerbation
3 exacerbations separated by at least 7 days
Unstable asthma resulting in medication changes
Ringo Starr narrated 'Thomas & Friends', a job later taken on by this comedian.
Who is George Carlin?
PRACTICE CHANGING GUIDELINES
True or False: This study resulted in change of the 2019 GINA asthma guidelines.
False. GINA changed d/t SYGMA 1 & 2. This study helps solidify the recommendations and was published after the guideline change.
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In conclusion, this clinical trial, in which an open-label design was used to reflect clinical practice, showed that budesonide–formoterol used as needed was superior to albuterol used as needed for the prevention of exacerbations in adults with mild asthma but did not control symptoms better than maintenance therapy.