Validation of the AQLQ12+ among adolescents and adults with persistent asthma

Abstract

These findings provide strong support for the measurement properties of the AQLQ12+ among patients with persistent asthma and confidence in the AQLQ12+ improvements demonstrated by the MF/F treatment group.

Effectiveness and Safety of Bronchial Thermoplasty in Management of Asthma

“…20 In the single-arm extension of this study, overall respiratory-related hospitalizations decreased in patients treated with BT and standard care over 5 years compared with baseline, but the change was not statistically significant. 23 Similarly, while the rate of ED visits over 5 years declined compared to the baseline rate, the change was not statistically significant in this small study. 23 Low-strength evidence from the AIR 2 trial (n=288) found that patients treated with BT and standard care had fewer severe exacerbations (those requiring systemic corticosteroids or doubling of ICS dose) in the post-treatment period (i.e., 6 weeks after the last BT procedure through 12 months) than patients treated with the sham bronchoscopic procedure and standard care.…”

“…23 Similarly, while the rate of ED visits over 5 years declined compared to the baseline rate, the change was not statistically significant in this small study. 23 Low-strength evidence from the AIR 2 trial (n=288) found that patients treated with BT and standard care had fewer severe exacerbations (those requiring systemic corticosteroids or doubling of ICS dose) in the post-treatment period (i.e., 6 weeks after the last BT procedure through 12 months) than patients treated with the sham bronchoscopic procedure and standard care. The posterior probability of superiority (PPS) for this result was 95.5 percent, meeting the study's criterion for statistical significance for this outcome.…”

“…20 In the RISA extension, postbronchodilator FEV1 (% predicted) did not significantly decline in the group receiving BT and standard care over 5 years of followup or in the control group over 3 years of followup. 23 In the AIR study (n=112), patients treated with BT and standard care had greater increases in morning and evening PEF compared with standard care alone) from baseline to 12 months; differences in FEV1 (% predicted, prebronchodilator) were not significant. 19 This evidence from the AIR and RISA trials was considered inconclusive (SOE: insufficient).…”

“…Six trials, including three RCTs (n=432) [18][19][20] and their 5-year, single-arm extension studies, [21][22][23] provided outcomes related to safety and efficacy. One of the extension studies also reported data for the control arm through 3 years.…”

“…22 At year 5 of the RISA extension, adverse event rates in patients treated with BT were chest discomfort (8.3%), cough (0%), discolored sputum (0%), and wheezing (8.3%). 23 The control group was not included in the 5-year followup. At year 5 of the AIR extension, rates of these common adverse events were bronchial irritation (2.4%), chest discomfort (4.8%), cough (4.8%), discolored sputum (0%), dyspnea (9.5%), productive cough (2.4%), night awakenings (0%), and wheezing (4.8%).…”