Cardiovascular safety profile of a fixed-dose combination of glycopyrrolate and formoterol fumarate delivered via metered dose inhaler using co-suspension delivery technology

Pulmonary Pharmacology and Therapeutics

Volumn 49, Issue , 2018, Pages 67-74

  Ferguson, Gary T ^a   Reisner, Colin ^b   Pearle, James ^c   DePetrillo, Paolo ^d   Maes, Andrea ^b   Martin, Ubaldo J ^b  

^a Pulmonary Research Institute of Southeast Michigan   (United States)

^b ASTRAZENECA   (United Kingdom)

^c California Research Medical Group   (United States)

^d SNBL Clinical Pharmacology Center   (United States)

Author keywords

Bronchodilator agents; Chronic obstructive; Electrocardiography; GFF MDI; Holter monitoring; Pulmonary disease; QT prolongation

Indexed keywords

FORMOTEROL FUMARATE; FORMOTEROL FUMARATE PLUS GLYCOPYRRONIUM BROMIDE; GLYCOPYRRONIUM; IPRATROPIUM BROMIDE; MOXIFLOXACIN; SALBUTAMOL SULFATE; BRONCHODILATING AGENT; MUSCARINIC RECEPTOR BLOCKING AGENT;

ADULT; AGED; ARTICLE; CARDIOVASCULAR EFFECT; CHRONIC OBSTRUCTIVE LUNG DISEASE; CONTROLLED STUDY; COUGHING; CROSSOVER PROCEDURE; DISEASE DURATION; DIZZINESS; DRUG DELIVERY SYSTEM; DRUG SAFETY; DYSPNEA; FEMALE; HEART RATE; HOLTER MONITORING; HUMAN; HYPERCHLOREMIA; HYPERKALEMIA; HYPERTENSION; HYPOGLYCEMIA; HYPOKALEMIA; HYPOMAGNESEMIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NERVOUSNESS; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SIDE EFFECT; SINUS NODE DISEASE; SUSPENSION; TACHYCARDIA; TREMOR; UPPER RESPIRATORY TRACT INFECTION; XEROSTOMIA; ADOLESCENT; CLINICAL TRIAL; COMPARATIVE STUDY; DOUBLE BLIND PROCEDURE; DRUG COMBINATION; LONG QT SYNDROME; METERED DOSE INHALER; MIDDLE AGED; PATHOPHYSIOLOGY; PHARMACEUTICS; PROCEDURES; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; BRONCHODILATOR AGENTS; CROSS-OVER STUDIES; DOUBLE-BLIND METHOD; DRUG COMBINATIONS; DRUG DELIVERY SYSTEMS; FEMALE; FORMOTEROL FUMARATE; GLYCOPYRROLATE; HUMANS; LONG QT SYNDROME; MALE; METERED DOSE INHALERS; MIDDLE AGED; MOXIFLOXACIN; MUSCARINIC ANTAGONISTS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; TECHNOLOGY, PHARMACEUTICAL; YOUNG ADULT;

EID: 85042670677     PISSN: 10945539     EISSN: 15229629     Source Type: Journal    
DOI: 10.1016/j.pupt.2018.01.007     Document Type: Article

References (31)

1. Global Initiative for Chronic Obstructive Lung Disease, Global Strategy for the Diagnosis, Management and Prevention of COPD. 2017 http://www.goldcopd.org. (Accessed 8 September 2017)
2. Miravitlles, M., Vogelmeier, C., Roche, N., Halpin, D., Cardoso, J., Chuchalin, A.G., et al. A review of national guidelines for management of COPD in Europe. Eur. Respir. J. 47 (2016), 625–637.
3. Qaseem, A., Wilt, T.J., Weinberger, S.E., Hanania, N.A., Criner, G., van der Molen, T., et al. Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann. Intern. Med. 155 (2011), 179–191.
4. AstraZeneca Pharmaceuticals LP, Bevespi Aerosphere™ Prescribing Information. 2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208294s000lbl.pdf. (Accessed 21 September 2017)
5. ® Prescribing Information. 2012 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020831s028lbl.pdf. (Accessed 21 September 2017)
6. ® Prescribing Information. 2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207923s002lbl.pdf. (Accessed 21 September 2017)
7. ® Summary of Product Characteristics. 2017 https://www.medicines.org.uk/emc/medicine/27138. (Accessed 21 September 2017)
8. ® Summary of Product Characteristics, 2016 https://www.medicines.org.uk/emc/medicine/1286. (Accessed 21 September 2017)
9. ® Breezhaler Summary of Product Characteristics. 2016 https://www.medicines.org.uk/emc/medicine/29533. (Accessed 21 September 2017)
10. ® Prescribing Information. 2017 https://www.utibron.com/Utibron-Prescribing-Information.pdf. (Accessed 21 September 2017)
11. AstraZeneca AB, Duaklir Genuair Summary of Product Characteristics. 2017 https://www.medicines.org.uk/emc/medicine/29652. (Accessed 21 September 2017)
12. Lahousse, L., Verhamme, K.M., Stricker, B.H., Brusselle, G.G., Cardiac effects of current treatments of chronic obstructive pulmonary disease. Lancet Respir. Med 4 (2016), 149–164.
13. Gershon, A., Croxford, R., Calzavara, A., To, T., Stanbrook, M.B., Upshur, R., et al. Cardiovascular safety of inhaled long-acting bronchodilators in individuals with chronic obstructive pulmonary disease. JAMA Intern. Med 173 (2013), 1175–1185.
14. Martinez, F.J., Rabe, K.F., Ferguson, G.T., Fabbri, L.M., Rennard, S., Feldman, G.J., et al. Efficacy and safety of glycopyrrolate/formoterol metered dose inhaler formulated using co-suspension delivery technology in patients with COPD. Chest 151 (2017), 340–357.
15. ® Delivery Technology in pressurized metered-dose inhalers for multi-drug dosing in the treatment of respiratory diseases. Respir. Med. 134 (2018), 16–23.
16. Doty, A., Schroeder, J., Vang, K., Sommerville, M., Taylor, M., Flynn, B., et al. Drug delivery from an innovative LAMA/LABA co-suspension delivery technology fixed-dose combination MDI: evidence of consistency, robustness, and reliability. AAPS PharmSciTech, 2017, 10.1208/s12249-017-0891-1.
17. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline: the Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-antiarrhythmic Drugs E14. 2005 https://www.ich.org/. (Accessed 21 September 2017)
18. Celli, B.R., MacNee, W., Committee members, Standards for the diagnosis and treatment of patients with COPD: a summary of the ATS/ERS position paper. Eur. Respir. J. 23 (2004), 932–946.
19. Hankinson, J.L., Odencrantz, J.R., Fedan, K.B., Spirometric reference values from a sample of the general U.S. population. Am. J. Respir. Crit. Care Med. 159 (1999), 179–187.
20. National Center for Health Statistics, Third National Health and Nutrition Examination Survey III Spirometry Procedure Manual. 1988 https://wwwn.cdc.gov/nchs/nhanes/nhanes3/manualsandreports.aspx. (Accessed 21 September 2017)
21. Boehringer Ingelheim International GmbH, Spiolto Respimat Summary of Product Characteristics. 2017 https://www.medicines.org.uk/emc/medicine/30495. (Accessed 8 September 2017)
22. Khindri, S., Sabo, R., Harris, S., Woessner, R., Jennings, S., Drollmann, A.F., Cardiac safety of indacaterol in healthy subjects: a randomized, multidose, placebo- and positive-controlled, parallel-group thorough QT study. BMC Pulm. Med., 11, 2011, 31.
23. ® Summary of Product Characteristics, 2015 http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206756Orig1s000lbl.pdf. (Accessed 21 September 2017)
24. 2 -agonist olodaterol on the QT and QTc interval in healthy subjects. Am. J. Respir. Crit. Care Med., 187, 2013, A2603.
25. Kelleher, D., Tombs, L., Preece, A., Brealey, N., Mehta, R., A randomized, placebo- and moxifloxacin-controlled thorough QT study of umeclidinium monotherapy and umeclidinium/vilanterol combination in healthy subjects. Pulm. Pharmacol. Therapeut. 29 (2014), 49–57.
26. Hanania, N.A., Tashkin, D.P., Kerwin, E.M., Donohue, J.F., Denenberg, M., O'Donnell, D.E., et al. Long-term safety and efficacy of glycopyrrolate/formoterol metered dose inhaler using novel Co-Suspension™ Delivery Technology in patients with chronic obstructive pulmonary disease. Respir. Med. 126 (2017), 105–115.
27. Singh, D., Ciurlia, G., Piccinno, A., Muraro, A., Bocchi, M., Scuri, M., Acute cardiovascular safety of two formulations of beclometasone dipropionate/formoterol fumarate in COPD patients: a single-dose, randomised, placebo-controlled crossover study. Pulm. Pharmacol. Therapeut. 42 (2017), 43–51.
28. Drollmann, A., Brown, M., Sechaud, R., Perry, S., Hara, H., Jones, I., et al. Effect of dual bronchodilation with QVA149 on cardiac safety in healthy volunteers. Int. J. Clin. Pharmacol. Ther 52 (2014), 369–380.
29. Drollmann, A., Sechaud, R., Pal, P., Hara, H., Uziel-Fusi, S., Winkle, P., Glycopyrronium does not affect QT interval in healthy subjects: a randomized, three- period, cross-over, placebo- and positive-controlled study. Int. J. Clin. Pharmacol. Ther 52 (2014), 739–745.
30. Edgell, H., Moore, L.E., Chung, C., Byers, B.W., Stickland, M.K., Short-term cardiovascular and autonomic effects of inhaled salbutamol. Respir. Physiol. Neurobiol. 231 (2016), 14–20.
31. Battisti, W.P., Wager, E., Baltzer, L., Bridges, D., Cairns, A., Carswell, C.I., et al. Good publication practice for communicating company-sponsored medical research: GPP3. Ann. Intern. Med. 163 (2015), 461–464.