Significantly more adult patients with severe asthma achieved an improvement in asthma symptom control (as measured by ACQ-7 responder rate) with SPIRIVA® Respimat® vs placebo Respimat.1
Post hoc analysis: pooled analysis of ACQ-7† responder rate at week 48.
At week 48, a higher proportion of patients achieved an ACQ-7 response with SPIRIVA Respimat vs placebo Respimat (58.1% vs 45.2%; OR 1.68, 95% CI 1.28-2.21; p<0.001).1,2
†A response was defined as a change in ACQ-7 score from study baseline of ≥0.5.1
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PrimoTinA Study Design
Two replicate randomised controlled trials (PrimoTinA-Asthma 1 and PrimoTinA-Asthma 2) compared SPIRIVA Respimat with placebo Respimat over 48 weeks as add-on controller therapy on top of usual care in adult patients with severe asthma who were symptomatic on maintenance treatment of at least ICS (≥800 μg budesonide/day or equivalent) plus LABA, had a post-bronchodilator FEV1 of ≤80% of the predicted value and a history of ≥1 severe exacerbation in the previous year. In both the SPIRIVA Respimat and placebo Respimat groups, ICS and LABA maintenance therapy was continued. Other asthma medications were allowed if the doses remained stable for ≥4 weeks before study entry and for the duration of the trial. The co-primary endpoints were lung function measured as peak FEV1(0-3h) and trough FEV1 response at week 24, and time to first severe exacerbation (pooled data) over 48 weeks.3
Abbreviations
ACQ-7, seven-question Asthma Control Questionnaire; CI, confidence interval; ICS, inhaled corticosteroid; LABA, long-acting β2-agonist; OR, odds ratio.
References: 1. Kerstjens HA et al. Respir Med 2016;117:198–206. 2. Murphy K et al. Ann Allergy Asthma Immunol 2013;113(Supl 1):Abstract P294. 3. Kerstjens HA et al. N Engl J Med 2012;367:1198–207.