BACKGROUND: Consistent delivery of medication to treat @entity565 and @entity1030 ( @entity1030 ) is critical for disease control. Dose tracking may eliminate the possibility of sub-therapeutic dosing. This study evaluated the overall performance, including accuracy and ruggedness, of the @entity10438 / @entity6410 (MF/F) @entity4185 ( @entity4185 ) with an integrated numerical dose-counting mechanism in adolescent and adult subjects (aged >=  12 y) with persistent @entity565 or @entity1030 . METHODS: In a phase III, open-label, single-arm, multicenter study, subjects demonstrating at least 90% compliance with MF/F during the screening period received twice daily MF/F @entity4185 100/10  g with the integrated dose counter for 4 weeks. Accuracy and ruggedness of the dose counter were assessed by the overall discrepancy rate of subject-recorded actuations versus subject-recorded dose counter readings. Discrepancy rates for Counterstrip   , a manual counting method, were evaluated for reference. Compliance and ergonomic safety were also assessed. RESULTS: The 233 subjects who used >=  90% of labeled actuations were included in the primary analysis. Of 26,317 total actuations, 33 dose counter discrepancies occurred (rate = 0.13/100 actuations), of which 13 were due to undercounting. In comparison, the Counterstrip discrepancy rate was 10-fold higher (1.34/100 actuations). Compliance with medication use, Counterstrip use, and e-diary recordings were all high (>98%). No new repetitive strain injuries or exacerbations of preexisting ergonomic injuries of the finger, hand, or arm were reported. CONCLUSIONS: The MF/F @entity4185 dose counter was accurate and rugged in subjects with @entity565 or @entity1030 . No new repetitive strain injuries or exacerbations of existing ergonomic injuries were associated with inhaler use. CLINICAL TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier = NCT00604500.

Dose counter performance of @entity10438 / @entity6410 inhalers in subjects with @entity565 or XXXX .

@entity565 :: ('MESH:D001249', 'Disease') :: ['asthma'] @entity4185 :: ('MESH:D058545', 'Disease') :: ['MDI', 'metered-dose inhaler'] @entity1030 :: ('MESH:D029424', 'Disease') :: ['chronic obstructive pulmonary disease', 'COPD'] @entity6410 :: ('MESH:C012629', 'Chemical') :: ['formoterol'] @entity10438 :: ('MESH:C053915', 'Chemical') :: ['mometasone furoate']
@entity1030 :: (MESH:D029424,Disease) :: ['COPD']
