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Dose-dependent anti-inflammatory effect of inhaled mometasone furoate/formoterol in subjects with asthma.
Respir Med 2013; 107(5):656-64RM

Abstract

OBJECTIVE

A well-controlled study in patients with allergic asthma was warranted to assess dose-dependency between fractional concentration of exhaled nitric oxide (FeNO) and sputum eosinophils to a combination of an inhaled corticosteroid plus a long-acting β2-agonist. We sought to characterize the dose-dependency of mometasone furoate/formoterol (MF/F) using FeNO and sputum eosinophil percentage as surrogates of airway inflammation in subjects with allergic asthma.

METHODS

Following a 2-week, open-label run-in, 93 subjects (≥12 y) using only short-acting beta agonist reliever medication as needed, were randomized to twice daily (BID) placebo; MF/F 100/10 μg, 200/10 μg, or 400/10 μg (via pressurized metered-dose inhaler [MDI]); MF-MDI 200 μg; or MF 200 μg via dry powder inhaler (DPI) during a 2-week, double-blind treatment period.

RESULTS

All active treatments demonstrated significant percentage reductions from baseline in FeNO compared with placebo at all time points (P ≤ 0.034). At endpoint, mean MF/F treatment group FeNO reductions ranged from -35.3% to -61.4%. Sputum eosinophil percentage reductions from baseline were significant compared with placebo for the MF/F 200/10 μg, MF/F 400/10 μg, and MF-DPI 200 μg groups at endpoint (P ≤ 0.023). Escalating MF/F doses significantly reduced both FeNO (P ≤ 0.001) and sputum eosinophil (P ≤ 0.022) levels in a dose-dependent manner at all time points. All treatments were well tolerated; no serious adverse events were observed.

CONCLUSION

All 3 MF/F doses demonstrated pronounced, clinically meaningful, dose-dependent reductions in FeNO, with reduced sputum eosinophil levels for MF/F 200/10 μg and MF/F 400/10 μg. These findings suggest both inflammatory markers may be useful in assessing corticosteroid responsiveness in asthma patients, and perhaps identifying the same asthma subphenotype. Clinical Trials.gov: NCT00635882.

Authors+Show Affiliations

Merck Sharp & Dohme Corp., Whitehouse Station, NJ 08889, USA. hendrik.nolte@merck.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23490226

Citation

Nolte, Hendrik, et al. "Dose-dependent Anti-inflammatory Effect of Inhaled Mometasone Furoate/formoterol in Subjects With Asthma." Respiratory Medicine, vol. 107, no. 5, 2013, pp. 656-64.
Nolte H, Pavord I, Backer V, et al. Dose-dependent anti-inflammatory effect of inhaled mometasone furoate/formoterol in subjects with asthma. Respir Med. 2013;107(5):656-64.
Nolte, H., Pavord, I., Backer, V., Spector, S., Shekar, T., Gates, D., ... Hargreave, F. (2013). Dose-dependent anti-inflammatory effect of inhaled mometasone furoate/formoterol in subjects with asthma. Respiratory Medicine, 107(5), pp. 656-64. doi:10.1016/j.rmed.2013.02.010.
Nolte H, et al. Dose-dependent Anti-inflammatory Effect of Inhaled Mometasone Furoate/formoterol in Subjects With Asthma. Respir Med. 2013;107(5):656-64. PubMed PMID: 23490226.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Dose-dependent anti-inflammatory effect of inhaled mometasone furoate/formoterol in subjects with asthma. AU - Nolte,Hendrik, AU - Pavord,Ian, AU - Backer,Vibeke, AU - Spector,Sheldon, AU - Shekar,Tulin, AU - Gates,Davis, AU - Nair,Parameswaran, AU - Hargreave,Frederick, Y1 - 2013/03/13/ PY - 2012/04/26/received PY - 2013/01/28/revised PY - 2013/02/11/accepted PY - 2013/3/16/entrez PY - 2013/3/16/pubmed PY - 2013/10/1/medline SP - 656 EP - 64 JF - Respiratory medicine JO - Respir Med VL - 107 IS - 5 N2 - OBJECTIVE: A well-controlled study in patients with allergic asthma was warranted to assess dose-dependency between fractional concentration of exhaled nitric oxide (FeNO) and sputum eosinophils to a combination of an inhaled corticosteroid plus a long-acting β2-agonist. We sought to characterize the dose-dependency of mometasone furoate/formoterol (MF/F) using FeNO and sputum eosinophil percentage as surrogates of airway inflammation in subjects with allergic asthma. METHODS: Following a 2-week, open-label run-in, 93 subjects (≥12 y) using only short-acting beta agonist reliever medication as needed, were randomized to twice daily (BID) placebo; MF/F 100/10 μg, 200/10 μg, or 400/10 μg (via pressurized metered-dose inhaler [MDI]); MF-MDI 200 μg; or MF 200 μg via dry powder inhaler (DPI) during a 2-week, double-blind treatment period. RESULTS: All active treatments demonstrated significant percentage reductions from baseline in FeNO compared with placebo at all time points (P ≤ 0.034). At endpoint, mean MF/F treatment group FeNO reductions ranged from -35.3% to -61.4%. Sputum eosinophil percentage reductions from baseline were significant compared with placebo for the MF/F 200/10 μg, MF/F 400/10 μg, and MF-DPI 200 μg groups at endpoint (P ≤ 0.023). Escalating MF/F doses significantly reduced both FeNO (P ≤ 0.001) and sputum eosinophil (P ≤ 0.022) levels in a dose-dependent manner at all time points. All treatments were well tolerated; no serious adverse events were observed. CONCLUSION: All 3 MF/F doses demonstrated pronounced, clinically meaningful, dose-dependent reductions in FeNO, with reduced sputum eosinophil levels for MF/F 200/10 μg and MF/F 400/10 μg. These findings suggest both inflammatory markers may be useful in assessing corticosteroid responsiveness in asthma patients, and perhaps identifying the same asthma subphenotype. Clinical Trials.gov: NCT00635882. SN - 1532-3064 UR - https://www.unboundmedicine.com/medline/citation/23490226/Dose-dependent_anti-inflammatory_effect_of_inhaled_mometasone_furoate/formoterol_in_subjects_with_asthma L2 - https://linkinghub.elsevier.com/retrieve/pii/S0954-6111(13)00059-0 DB - PRIME DP - Unbound Medicine ER -