Pragmatic trials powered to detect real-life differences in HRQoL and head-to-head comparison are needed to guide clinical practice in terms of PROs. Moreover, due to the different molecule properties, treatment schedule, and device characteristics of each FDC, a generalized judgment seems inappropriate.
Conclusion: LABA/LAMA FDCs may be helpful in improving HRQoL, but because of the heterogeneity of performed trials, strong conclusions cannot be drawn.
In 5 out of 6 RCTs having LABA/ICS as comparators, LABA/LAMA FDC had a similar effect and only 1 showed significant improvement in HRQL compared to LABA/ICS FDC. LABA/LAMA FDCs significantly improved HRQoL versus placebo in 9 out of 11 trials, while change when compared to other LABA or LAMA monocomponents was significantly better in 11 out 24. Using the St George’ s Respiratory Questionnaire, 27 out of 28 trials assessed HRQoL. Results: Twenty-eight RCTs ( n = 32, 165 COPD patients) investigating the impact of fixed LABA/LAMA combinations on HRQoL were included.
Methods: A systematic literature search for randomized controlled trials (RCTs) about the impact of LABA/LAMA FDCs versus placebo, LABA or LAMA or LABA/ICS on HRQoL in Chronic obstructive pulmonary disease (COPD) patients has been performed. LABA provides relief of breathlessness and chest. Objectives: To review current available evidence about the treatment effect of fixed LABA/LAMA FDCs on HRQoL. The combination of bronchodilator and corticosteroid allows for airway dilation over a prolonged period. Improvements in efficacy endpoints were also sustained over 52 weeks.Background: While fixed dose combinations (FDCs) of long-acting beta 2-agonists (LABAs) and long-acting muscarinic antagonists (LAMAs) are increasingly tested on their efficacy in improving lung function, their effectiveness on Patient Reported Outcomes (PROs) such as Health Related Quality of Life (HRQoL) and Health Status (HS) deserve more attention. In addition, long-term safety and tolerability was demonstrated in Pinnacle-3, a 28-week extension study of Pinnacle-1 and -2 (n=892). The combination of formoterol and glycopyrronium was found to have a safety and tolerability profile similar to that of placebo, monocomponent MDIs and open-label tiotropium in Pinnacle-1, -2 and -3. Improvement in disease-specific health-related quality of life, as indicated by a reduction in the St George's Respiratory Questionnaire (SGRQ) total score over 24 weeks, was also observed for formoterol/glycopyrronium MDI versus placebo, formoterol and glycopyrronium MDIs in Pinnacle-1 and -2 and versus placebo and glycopyrronium MDIs in Pinnacle-4. In Pinnacle-2 significant improvements compared with formoterol were also observed. Triple therapy can be prescribed as a single inhaler which. In Pinnacle-1, -2 and -4 the formoterol/glycopyrronium combination also provided significant improvements in breathlessness, as measured on the Self-Administered Computerised Transitional Dyspnoea Index (SAC TDI) focal score over 24 weeks compared with placebo and glycopyrronium. Triple therapy is delivery of a combination of all three inhaled drugs (LAMA+LABA+ICS).
The formoterol/glycopyrronium MDI significantly improved lung function relative to placebo and monocomponent MDIs in all three trials.Īt week 24, the differences in change from baseline in morning predose trough FEV 1 (the primary end point used in the studies) for formoterol/glycopyrronium MDI versus placebo, glycopyrronium and formoterol MDIs were: 150ml, 59ml and 64ml, respectively, in Pinnacle-1 (all p<0.0001) 103ml, 54ml and 56ml, respectively, in Pinnacle-2 (all p<0.001) and 165ml, 59ml and 72ml, respectively in Pinnacle-4 (all p<0.0001).
#COMBO INHALERS LAMA LABA TRIAL#
The Pinnacle-1 trial also included an open-label tiotropium dry powder inhaler arm. Patients in the Pinnacle-1 (n=2,103), Pinnacle-2 (n=1,615) and Pinnacle-4 studies (n=1,756) were randomised to one of four groups: formoterol/glycopyrronium MDI glycopyrronium MDI formoterol MDI or placebo MDI. The safety and efficacy of Bevespi Aerosphere were assessed in three 24-week randomised controlled trials involving patients with moderate to very severe COPD. Further information View Bevespi Aerosphere drug record MIMS Respiratory Clinic Clinical studies
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