PMID- 16556690 OWN - NLM STAT- MEDLINE DCOM- 20060707 LR - 20221207 IS - 1073-449X (Print) IS - 1073-449X (Linking) VI - 173 IP - 11 DP - 2006 Jun 1 TI - Dissociation of lung function changes with humoral immunity during inhaled human insulin therapy. PG - 1194-200 AB - RATIONALE: Inhaled human insulin (INH; Exubera [human insulin (recombinant DNA origin) Inhalation Powder]) causes small changes in pulmonary function and increases in insulin antibodies compared with subcutaneous (SC) insulin. OBJECTIVES: To investigate the relationship between changes in pulmonary function and insulin antibodies and acute effects of INH on lung function. METHODS: In a 24-wk multicenter study, 226 patients with type 1 diabetes were randomized to receive daily premeal INH or SC insulin for 12 wk (comparative phase), followed by SC insulin for 12 wk (washout phase). MEASUREMENTS: Spirometry tests were conducted and insulin antibody levels were measured throughout the study. Acute insulin-induced changes in lung function were calculated as the difference between FEV1 before, and 10 and 60 min after, insulin. MAIN RESULTS: There was a temporal dissociation between pulmonary function changes and insulin antibody generation. Small treatment group differences in changes in FEV1 from baseline, favoring SC insulin, were fully manifest by 2 wk of INH therapy, did not increase during the remainder of the comparative phase, and resolved within 2 wk of INH discontinuation. By contrast, insulin antibody levels remained low for the first 2 wk with INH, increased during Weeks 2 to 12, and gradually declined during washout. There was no evidence of acute insulin-induced alterations in lung function 10 and 60 min postinhalation. CONCLUSION: The small lung function changes observed with INH therapy are not mediated by the humoral immune response, or associated with acute decrements in lung function immediately after insulin inhalation. FAU - Teeter, John G AU - Teeter JG AD - Pfizer Global Research and Development, New London, CT 06320, USA. john.g.teeter@pfizer.com FAU - Riese, Richard J AU - Riese RJ LA - eng PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20060323 PL - United States TA - Am J Respir Crit Care Med JT - American journal of respiratory and critical care medicine JID - 9421642 RN - 0 (Exubera) RN - 0 (Glycated Hemoglobin A) RN - 0 (Hypoglycemic Agents) RN - 0 (Insulin) RN - 0 (Insulin Antibodies) SB - IM MH - Administration, Inhalation MH - Adult MH - Aged MH - Diabetes Mellitus, Type 1/*drug therapy/physiopathology MH - Female MH - Forced Expiratory Volume/*drug effects MH - Glycated Hemoglobin/analysis MH - Humans MH - Hypoglycemic Agents/administration & dosage/*therapeutic use MH - Injections, Subcutaneous MH - Insulin/administration & dosage/*therapeutic use MH - Insulin Antibodies/*blood MH - Male MH - Middle Aged MH - Respiratory Function Tests EDAT- 2006/03/25 09:00 MHDA- 2006/07/11 09:00 CRDT- 2006/03/25 09:00 PHST- 2006/03/25 09:00 [pubmed] PHST- 2006/07/11 09:00 [medline] PHST- 2006/03/25 09:00 [entrez] AID - 200512-1861OC [pii] AID - 10.1164/rccm.200512-1861OC [doi] PST - ppublish SO - Am J Respir Crit Care Med. 2006 Jun 1;173(11):1194-200. doi: 10.1164/rccm.200512-1861OC. Epub 2006 Mar 23.