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Q In patients with poorly controlled asthma while taking medication, what is the effectiveness of adding once daily oral controller therapy to low dose theophylline or montelukast?
Clinical impact ratings GP/FP/Primary care ★★★★★★☆ IM/Ambulatory care ★★★★★☆☆ Respirology ★★★★★★☆ Allergy & immunology ★★★★★☆☆
METHODS
Design:
randomised placebo controlled trial.
Allocation:
{concealed*}†.
Blinding:
blinded (clinicians, patients, {data collectors, outcome assessors, and data safety and monitoring committee}†).*
Follow up period:
24 weeks.
Setting:
19 American Lung Association Asthma Clinical Research Centres (ALA-ACRC) in the US.
Patients:
489 patients ⩾15 years of age (mean age 40 y, 74% women, 61% white) who were diagnosed with asthma, were prescribed daily asthma medication for ⩾1 year, had FEV1 ⩾50% of the predicted value, and had poor asthma control (score ⩾1.5 on the Asthma Control Questionnaire [ACQ]). Patients continued their baseline medications. Exclusion criteria were use of oral corticosteroids, leukotriene antagonists, or theophylline within 4 weeks before randomisation; ⩾20 …