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Pharmacodynamic steady state of tiotropium in patients with chronic obstructive pulmonary disease.
Eur Respir J. 2002 Apr; 19(4):639-44.ER

Abstract

Tiotropium (Spiriva) is a new once-daily inhaled anticholinergic that has its effect through prolonged muscarinic (M)3 receptor antagonism. It has a clinically documented, long duration of action with once-daily dosing in chronic obstructive pulmonary disease (COPD). A single-centre, double-blind, ipratropium-controlled study was conducted in order to characterize the onset of pharmacodynamic steady state of tiotropium in patients with COPD. Thirty-one patients (25 male, six female) with a mean age of 62 yrs and a mean forced expiratory volume in one second (FEV1) of 1.13 L (38% of predicted) were randomly assigned to receive either tiotropium 18 microg once-daily from a dry-powder inhaler (HandiHaler, 20 patients), or ipratropium 40 microg four-times daily from a pressurized metered-dose inhaler (11 patients) for a period of 1 week. FEV1 and forced vital capacity (FVC) were measured 1 h prior to, and just before inhalation (mean value of the two measurements on test-day 1 was the baseline value, while on all other test days it was the trough value), and 0.5, 1, 2, 3, 4, 5, and 6 h after inhalation of the morning dose of the study drug (one capsule and two puffs) on days 1, 2, 3, and 8. Trough FEV1 following 8 days of tiotropium was 0.19 L (18%) above baseline. Approximately 90% of this increase was achieved within 24 h of the first dose (0.17 L, 16%). Trough FVC increased 0.67 L (27%) on test-day 8. Approximately 70% of the improvement was observed after two tiotropium doses (0.47 L, 19%). Achievement of FVC steady state was delayed compared to FEV1. Ipratropium performed typically with an onset of action within 30 min, a peak response between 1-2 h postdosing and a duration of action of approximately 4 h. It was concluded that forced expiratory volume in one second steady state with tiotropium is reached within 48 h, while continued improvements in forced vital capacity can be expected over or beyond the first week of therapy. The continued increases in forced vital capacity beyond 48 h suggests that maintenance bronchodilator therapy is required to achieve maximal changes in hyperinflation.

Authors+Show Affiliations

Dept of Respiratory Diseases, Atrium Medical Centre, Heerlen, The Netherlands. longarts.om@wolmail.nlNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

11998992

Citation

van Noord, J A., et al. "Pharmacodynamic Steady State of Tiotropium in Patients With Chronic Obstructive Pulmonary Disease." The European Respiratory Journal, vol. 19, no. 4, 2002, pp. 639-44.
van Noord JA, Smeets JJ, Custers FL, et al. Pharmacodynamic steady state of tiotropium in patients with chronic obstructive pulmonary disease. Eur Respir J. 2002;19(4):639-44.
van Noord, J. A., Smeets, J. J., Custers, F. L., Korducki, L., & Cornelissen, P. J. (2002). Pharmacodynamic steady state of tiotropium in patients with chronic obstructive pulmonary disease. The European Respiratory Journal, 19(4), 639-44.
van Noord JA, et al. Pharmacodynamic Steady State of Tiotropium in Patients With Chronic Obstructive Pulmonary Disease. Eur Respir J. 2002;19(4):639-44. PubMed PMID: 11998992.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Pharmacodynamic steady state of tiotropium in patients with chronic obstructive pulmonary disease. AU - van Noord,J A, AU - Smeets,J J, AU - Custers,F L J, AU - Korducki,L, AU - Cornelissen,P J G, PY - 2002/5/10/pubmed PY - 2002/10/31/medline PY - 2002/5/10/entrez SP - 639 EP - 44 JF - The European respiratory journal JO - Eur. Respir. J. VL - 19 IS - 4 N2 - Tiotropium (Spiriva) is a new once-daily inhaled anticholinergic that has its effect through prolonged muscarinic (M)3 receptor antagonism. It has a clinically documented, long duration of action with once-daily dosing in chronic obstructive pulmonary disease (COPD). A single-centre, double-blind, ipratropium-controlled study was conducted in order to characterize the onset of pharmacodynamic steady state of tiotropium in patients with COPD. Thirty-one patients (25 male, six female) with a mean age of 62 yrs and a mean forced expiratory volume in one second (FEV1) of 1.13 L (38% of predicted) were randomly assigned to receive either tiotropium 18 microg once-daily from a dry-powder inhaler (HandiHaler, 20 patients), or ipratropium 40 microg four-times daily from a pressurized metered-dose inhaler (11 patients) for a period of 1 week. FEV1 and forced vital capacity (FVC) were measured 1 h prior to, and just before inhalation (mean value of the two measurements on test-day 1 was the baseline value, while on all other test days it was the trough value), and 0.5, 1, 2, 3, 4, 5, and 6 h after inhalation of the morning dose of the study drug (one capsule and two puffs) on days 1, 2, 3, and 8. Trough FEV1 following 8 days of tiotropium was 0.19 L (18%) above baseline. Approximately 90% of this increase was achieved within 24 h of the first dose (0.17 L, 16%). Trough FVC increased 0.67 L (27%) on test-day 8. Approximately 70% of the improvement was observed after two tiotropium doses (0.47 L, 19%). Achievement of FVC steady state was delayed compared to FEV1. Ipratropium performed typically with an onset of action within 30 min, a peak response between 1-2 h postdosing and a duration of action of approximately 4 h. It was concluded that forced expiratory volume in one second steady state with tiotropium is reached within 48 h, while continued improvements in forced vital capacity can be expected over or beyond the first week of therapy. The continued increases in forced vital capacity beyond 48 h suggests that maintenance bronchodilator therapy is required to achieve maximal changes in hyperinflation. SN - 0903-1936 UR - https://www.unboundmedicine.com/medline/citation/11998992/Pharmacodynamic_steady_state_of_tiotropium_in_patients_with_chronic_obstructive_pulmonary_disease_ L2 - http://erj.ersjournals.com/cgi/pmidlookup?view=long&pmid=11998992 DB - PRIME DP - Unbound Medicine ER -