Efficacy and safety were assessed in two 12-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter trials in subjects with moderate to very severe COPD. Subjects were randomized using a 1:1:1 ratio to 1 of 3 treatments: placebo BID, LONHALA MAGNAIR 25 mcg BID, and glycopyrrolate 50 mcg BID. Safety end points included the number and percentage of subjects with treatment-emergent adverse events (TEAEs) and serious AEs, and the number and percentage of subjects who discountinued treatment due to TEAEs.1,2
Pooled analysis of two 12-week trials
- The safety of LONHALA MAGNAIR was evaluated in two 12-week, randomized, double-blind, placebo-controlled, parallel group, confirmatory studies, and a 48-week, long-term, open-label safety clinical trial
Adverse reactions with ≥2% incidence and higher than placebo3
- The incidence of discontinuation due to adverse reactions was greater for placebo (9.3%) than for LONHALA MAGNAIR (5.1%)1
48-week, long-term, open-label safety clinical trial3
- Adverse reactions reported in a randomized, open-label, active-controlled, parallel-group, 48-week, long-term safety trial (N=620) were consistent with those observed in the 12-week studies (Study 1 and Study 2)
- Additional adverse reactions with LONHALA MAGNAIR (50 mcg BID) that occurred at a frequency greater than those seen in either active treatment dose in the pooled 12-week studies and ≥2% were diarrhea, edema peripheral, bronchitis, nasopharyngitis, pneumonia, sinusitis, upper respiratory tract infection, urinary tract infection, back pain, headache, COPD, cough, dyspnea, oropharyngeal pain, and hypertension
- Data on file. Integrated Summary of Safety. 156. Sunovion Pharmaceuticals Inc.
- Kerwin E, Donohue JF, Goodin T, et al. Efficacy and safety of glycopyrrolate/eFlow® CS (nebulized glycopyrrolate) in moderate-to-severe COPD: results from the glycopyrrolate for obstructive lung disease via electronic nebulizer (GOLDEN) 3 and 4 randomized controlled trials. Respir Med. 2017;132:238–250.
- LONHALA MAGNAIR [prescribing information]. Marlborough, MA: Sunovion Pharmaceuticals Inc.; 2018.