Short-term safety of somatropin inhalation powder in adults with mild to moderate asthma

Allergy and Asthma Proceedings

Volumn 30, Issue 3, 2009, Pages 325-332

  Nelson, Harold S ^a   Busse, William W ^b   Sanger, Mary ^c   Cutler, Gordon ^c   Ellwanger, Colleen ^d   Chipman, John J ^c  

^a DEPARTMENT OF MEDICINE   (United States)

^b UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH   (United States)

^c ELI LILLY AND COMPANY   (United States)

^d ALKERMES INC   (United States)

Author keywords

Asthma; Drug inhalation; FEV1; Growth hormone; Lung; Pulmonary; rhGH; Safety; Somatropin; Somatropin inhalation powder

Indexed keywords

HUMAN GROWTH HORMONE; METHACHOLINE; PLACEBO; SOMATOMEDIN C; BRONCHOCONSTRICTING AGENT; DIAGNOSTIC AGENT; METHACHOLINE CHLORIDE; RECOMBINANT PROTEIN;

ADULT; AREA UNDER THE CURVE; ARTICLE; ASTHMA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; CROSSOVER PROCEDURE; DISEASE SEVERITY; DRUG DOSAGE FORM COMPARISON; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FORCED EXPIRATORY VOLUME; HEADACHE; HUMAN; LUNG FUNCTION; MALE; NOSE CONGESTION; RANDOMIZED CONTROLLED TRIAL; UNSPECIFIED SIDE EFFECT; ADOLESCENT; COMPARATIVE STUDY; IMMUNOLOGY; INHALATION TEST; INHALATIONAL DRUG ADMINISTRATION; MIDDLE AGED;

ADMINISTRATION, INHALATION; ADOLESCENT; ADULT; ASTHMA; BRONCHIAL PROVOCATION TESTS; BRONCHOCONSTRICTOR AGENTS; FEMALE; HUMAN GROWTH HORMONE; HUMANS; MALE; METHACHOLINE CHLORIDE; MIDDLE AGED; RECOMBINANT PROTEINS; YOUNG ADULT;

EID: 68249149677     PISSN: 10885412     EISSN: 15396304     Source Type: Journal    
DOI: 10.2500/aap.2009.30.3236     Document Type: Article

References (33)

1. Scheuch G, Kohlhaeufl MJ, Brand P, et al. Clinical perspectives on pulmonary systemic and macromolecular delivery. Adv Drug Deliv Rev 58:996-1008, 2006.
2. Patton JS, and Byron PR. Inhaling medicines: Delivering drugs to the body through the lungs. Nat Rev Drug Discov 6:67-74, 2007.
3. Kwon MJ, Bae JH, Kim JJ, et al. Long acting porous microparticle for pulmonary protein delivery. Int J Pharm 333:5-9, 2007.
4. Chow AH, Tong HH, Chattopadhyay P, et al. Particle engineering for pulmonary drug delivery. Pharm Res 24:411-437, 2007.
5. Gumbleton M, and Taylor G. Challenges and innovations in effective pulmonary systemic and macromolecular drug delivery. Adv Drug Deliv Rev 58:993-995, 2006.
6. Mudaliar S, and Henry RR. Inhaled insulin in patients with asthma and chronic obstructive pulmonary disease. Diabetes Technol Ther 9(suppl 1):S83-S92, 2007.
7. Wolzt M, de la PA, Berclaz PY, et al. AIR(R) Inhaled insulin versus subcutaneous insulin: Pharmacokinetics, glucodynamics, and pulmonary function in asthma. Diabetes Care 31:735-740, 2008. (Epub ahead of print.)
8. Henry RR, Mudaliar SR, Howland WC III, et al. Inhaled insulin using the AERx Insulin Diabetes Management System in healthy and asthmatic subjects. Diabetes Care 26:764-769, 2003.
9. Edwards DA, Hanes J, Caponetti G, et al. Large porous particles for pulmonary drug delivery. Science 276:1868-1871, 1997.
10. Edwards DA, Ben-Jebria A, and Langer R. Recent advances in pulmonary drug delivery using large, porous inhaled particles. J Appl Physiol 85:379-385, 1998.
11. Vanbever R, Mintzes JD, Wang J, et al. Formulation and physical characterization of large porous particles for inhalation. Pharm Res 16:1735-1742, 1999.
12. Edwards DA, and Li W. Aerosol particle transport and deaggregation phenomena in the mouth and throat. Adv Drug Deliv Rev 26:41-49, 1997.
13. Lindholm J. Growth hormone: Historical notes. Pituitary 9:5-10, 2006.
14. Berger WE. Paediatric pulmonary drug delivery: Considerations in asthma treatment. Expert Opin Drug Deliv 2:965-980, 2005.
15. Masoli M, Fabian D, Holt S, et al. The global burden of asthma: Executive summary of the GINA Dissemination Committee Report. Allergy 59:469-478, 2004.
16. Chipman JJ, Attanasio AF, Birkett MA, et al. The safety profile of GH replacement therapy in adults. Clin Endocrinol 46:473-481, 1997.
17. Attanasio AF, Lamberts SW, Matranga AM, et al. Adult growth hormone (GH)-deficient patients demonstrate heterogeneity between childhood onset and adult onset before and during human GH treatment. Adult Growth Hormone Deficiency Study Group. J Clin Endocrinol Metab 82:82-88, 1997.
18. National Heart Lung and Blood Institute National Asthma Education and Prevention Program. Expert Panel Report 2: Guidelines for the diagnosis and management of asthma. Publication no. 97-4051, U.S. Department of Health and Human Services, National Institutes of Health, Bethesda, MD, 1997.
19. Crapo RO, Casaburi R, Coates AL, et al. Guidelines for methacholine and exercise challenge testing-1999. This official statement of the American Thoracic Society was adopted by the ATS Board of Directors, July 1999. Am J Respir Crit Care Med 161:309-329, 2000.
20. National Asthma Education and Prevention Program Expert Panel. Guidelines for the diagnosis and management of asthma - Update on selected topics. J Allergy Clin Immunol 110(suppl 1):S141-S218, 2002.
21. World Medical Association. World Medical Association declaration of Helsinki. Recommendations guiding physicians in biomedical research involving human subjects. JAMA 277:925-926, 1997.
22. Eli Lilly and Company. Somatropin (rDNA origin) for injection (Humatrope) package insert. Indianapolis, IN; June 2006.
23. Kung M, White JR, and Burki NK. The effect of subcutaneously administered terbutaline on serum potassium in asymptomatic adult asthmatics. Am Rev Respir Dis 129:329-332, 1984.
24. Coady TJ, Stewart CJ, and Davis HJ. Determination of the optimum dose of subcutaneous salbutamol in asthmatic patients. Br J Clin Pharmacol 3:239-242, 1976.
25. Santus P, Pecchiari M, Carlucci P, et al. Bronchodilation test in COPD: Effect of inspiratory manoeuvre preceding forced expiration. Eur Respir J 21:82-85, 2003.
26. American Thoracic Society. Standardization of spirometry, 1994 update. Am J Respir Crit Care Med 152:1107-1136, 1995.
27. Juniper EF, Frith PA, Dunnett C, et al. Reproducibility and comparison of responses to inhaled histamine and methacholine. Thorax 33:705-710, 2007.
28. DeLong M, Wright J, Dawson M, et al. Dose delivery characteristics of the AIR pulmonary delivery system over a range of inspiratory flow rates. J Aerosol Med 18:452-459, 2005.
29. Rosenstock J, Muchmore D, Swanson D, et al. AIR Inhaled Insulin System: A novel insulin delivery system for patients with diabetes. Exp Rev Med Dev 4:683-692, 2007.
30. Saito H. Anabolic agents in trauma and sepsis: Repleting body mass and function. Nutrition 14:554-556, 1998.
31. Chihara K, Koledova E, Shimatsu A et al. Adult GH deficiency in Japanese patients: Effects of GH treatment in a randomised, placebo-controlled trial. Eur J Endocrinol 151:343-350, 2004.
32. Ceglia L, Lau J, Pittas G. Meta-analysis: Efficacy and safety of inhaled insulin therapy in adults with diabetes mellitus. Ann Intern Med 145:665-675, 2006.
33. Hanley JA, and Lippman-Hand A. If nothing goes wrong, is everything all right? Interpreting zero numerators. JAMA 249:1743-1745, 1983.