PURPOSE: To characterize the effect of 2 strengths of mometasone furoate/formoterol (MF/F) on the health-related quality of life (HRQOL) in subjects with moderate−very severe chronic obstructive pulmonary disease (COPD). MF/F has been shown to be effective for the treatment of asthma in patients ≥12 yrs and is under investigation as a new treatment for COPD.
METHODS: The effect of MF/F on HRQOL was investigated in 2 identical multinational, multicenter, randomized, placebo-controlled trials in current or ex-smokers (≥10 pack-yrs) with moderate−very severe COPD (mean baseline [BL] % predicted FEV1, 39.6% [Trial 1]; 38.7% [Trial 2]). Subjects (≥40 yrs) were randomized to receive twice-daily (BID) inhaled MF/F 400/10µg (n1=217; n2=225), MF/F 200/10µg (n1=207; n2=239), MF 400µg (n1=210; n2=253), F 10µg (n1=209; n2=243), or PBO (n1=212; n2=236) for 26 wks. The effect of MF/F on HRQOL was measured after 26 wks using the Saint George’s Respiratory Questionnaire (SGRQ) score. The SGRQ is a 76-item, 3-domain pulmonary disease questionnaire; higher scores indicate greater disease burden (range, 0−100). A 4-point decrease in SGRQ total score vs BL or PBO is considered a minimum clinically important difference (MCID).
RESULTS: BID MF/F treatment was associated with significant improvements in HRQOL as measured by changes from BL in SGRQ total scores vs PBO at trial endpoint (wk 26, LOCF). In Trial 1, MF/F 400/10µg and 200/10µg were associated with changes of −7.43 and −5.69 vs −2.87 for those on PBO (P=0.002, MF/F 400/10µg vs PBO; MF/F 200/10µg was not significantly different vs PBO). In Trial 2, MF/F 400/10µg and 200/10µg were associated with changes from BL of −6.04 and −7.99 vs −2.88 for those on PBO (P=0.020 and P<0.001 vs PBO). Treatments with MF 400µg or F 10µg were also associated with reductions in SGRQ total scores, although these tended to be smaller than those observed with MF/F (−6.99 & −5.87 for MF 400µg and −6.18 & −4.93 for F 10µg in Trials 1 & 2, respectively; MF changes were significant vs PBO in both trials; F changes were significant vs PBO in Trial 1).
CONCLUSIONS: MF/F 400/10µg BID and 200/10µg BID treatments were associated with significant improvements in HRQOL as measured by changes from BL in SGRQ scores vs PBO. MCIDs were achieved for both MF/F groups vs BL in both trials, the MF/F 400/10µg BID group vs PBO in Trial 1, and the MF/F 200/10µg BID group vs PBO in Trial 2.
CLINICAL IMPLICATIONS: MF/F 400/10µg BID and 200/10µg BID are effective for improving HRQOL in subjects with moderate−very severe COPD.
DISCLOSURE: Edward Kerwin: Grant monies (from industry related sources): Merck
Donald Tashkin: University grant monies: Merck, Consultant fee, speaker bureau, advisory committee, etc.: Merck
Carlos Eduardo Matiz-Bueno: Other: Spouse is an employee of Merck
Dennis Doherty: University grant monies: Boehringer Ingelheim, Merck, Novartis, Pfizer, Grant monies (from sources other than industry): NIH-NHLBI, Department of Veterans Affairs, Consultant fee, speaker bureau, advisory committee, etc.: AstraZeneca, Boehringer Ingelheim, Forest, Ikaria, Merck, Pfizer
Tulin Shekar: Employee: Merck
Sibabrata Banerjee: Employee: Merck
Jonathan Sadeh: Employee: Merck
No Product/Research Disclosure Information