title: Pulmonary function over 2 years in diabetic patients treated with prandial inhaled Technosphere Insulin or usual antidiabetes treatment: a randomized trial.
abstract: OBJECTIVE
  Development of inhaled insulin has increased the need to understand its pulmonary safety. This study evaluated pulmonary function changes in diabetes patients receiving inhaled Technosphere Insulin (TI) or usual antidiabetes treatment (usual care).
  
  
  METHODS
  This randomized, open-label study was conducted at 220 sites (25 July 2005 to 29 August 2008). Pulmonary function tests [forced expiratory volume in 1 s (FEV(1)), forced vital capacity (FVC), total lung capacity (TLC) and lung diffusion capacity for carbon monoxide (DL(CO))] were prospectively followed over 2 years in patients with type 1 or type 2 diabetes receiving TI (n = 730) or usual care (n = 824), along with a cohort without diabetes not receiving any specific therapy (n = 145).
  
  
  RESULTS
  Baseline demographics and pulmonary function were similar between diabetes treatment groups. Lung function declined from baseline in all groups. TI was non-inferior to usual care for mean change in FEV(1) from baseline to month 24 [mean (s.e.m.) 0.037 (0.0119) l; 95% CI 0.014 to 0.060] using mixed-model repeated-measure with a pre-specified non-inferiority margin of 50 ml/year. After a greater initial decline at month 3 with TI, rate of change (slope) in FEV(1), FVC and DL(CO) (months 3-24) was not statistically different between treatment groups. TI was well tolerated; no serious safety concerns emerged. The most common respiratory event associated with TI was mild, transient cough, occurring within minutes of inhalation.
  
  
  CONCLUSIONS
  Observed changes in lung function with TI were small, occurred early after therapy initiation, remained non-progressive over 2 years and were unlikely to be clinically meaningful.
authors.affiliation: University of Texas Southwestern Medical Center at Dallas, Dallas, TX, USA.
authors.forename: P
authors.initials: P
authors.lastname: Raskin
authors.forename: S
authors.initials: S
authors.lastname: Heller
authors.forename: M
authors.initials: M
authors.lastname: Honka
authors.forename: P-C
authors.initials: PC
authors.lastname: Chang
authors.forename: A H
authors.initials: AH
authors.lastname: Boss
authors.forename: P C
authors.initials: PC
authors.lastname: Richardson
authors.forename: N
authors.initials: N
authors.lastname: Amin
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001992:Bronchoalveolar Lavage Fluid; D015331:Cohort Studies; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D004305:Dose-Response Relationship, Drug; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D007279:Injections, Subcutaneous; D007328:Insulin / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010316:Particle Size; D014109:Total Lung Capacity / Q000187:drug effects; D016896:Treatment Outcome; D014797:Vital Capacity / Q000187:drug effects; D055815:Young Adult
chemical_list: D007004:Hypoglycemic Agents; D007328:Insulin