drugset / Trial / NCT00000569
Lung Health Study II
Phase 3
Completed
1116 enrolled
University of Minnesota
National Heart, Lung, and Blood Institute (NHLBI) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
To determine if participants with chronic obstructive pulmonary disease, who were assigned to inhaled corticosteroids had a lower rate of decline in lung function and lower incidence of respiratory morbidity compared to participants assigned to placebo.
Timeline
- Start
- 1993-09
- Primary completion
- 1999-05
- Completion
- 1999-05
Publications
- Background Mapp CE. Inhaled glucocorticoids in chronic obstructive pulmonary disease. N Engl J Med. 2000 Dec 28;343(26):1960-1. doi: 10.1056/NEJM200012283432609. No abstract available.
- Background Lung Health Study Research Group; Wise R, Connett J, Weinmann G, Scanlon P, Skeans M. Effect of inhaled triamcinolone on the decline in pulmonary function in chronic obstructive pulmonary disease. N Engl J Med. 2000 Dec 28;343(26):1902-9. doi: 10.1056/NEJM200012283432601.
- Background Simmons MS, Nides MA, Rand CS, Wise RA, Tashkin DP. Unpredictability of deception in compliance with physician-prescribed bronchodilator inhaler use in a clinical trial. Chest. 2000 Aug;118(2):290-5. doi: 10.1378/chest.118.2.290.
- Background Tashkin DP, Murray HE, Skeans M, Murray RP. Skin manifestations of inhaled corticosteroids in COPD patients: results from Lung Health Study II. Chest. 2004 Oct;126(4):1123-33. doi: 10.1016/S0012-3692(15)31287-3.
- Background Scanlon PD, Connett JE, Wise RA, Tashkin DP, Madhok T, Skeans M, Carpenter PC, Bailey WC, Buist AS, Eichenhorn M, Kanner RE, Weinmann G; Lung Health Study Research Group. Loss of bone density with inhaled triamcinolone in Lung Health Study II. Am J Respir Crit Care Med. 2004 Dec 15;170(12):1302-9. doi: 10.1164/rccm.200310-1349OC. Epub 2004 Sep 16.
- Background Eichenhorn MS, Wise RA, Madhok TC, Gerald LB, Bailey WC, Tashkin DP, Scanlon PD; Lung Health Study Research Group. Lack of long-term adverse adrenal effects from inhaled triamcinolone: Lung Health Study II. Chest. 2003 Jul;124(1):57-62. doi: 10.1378/chest.124.1.57.
- Sze MA, Chen YW, Tam S, Tashkin D, Wise RA, Connett JE, Man SP, Sin DD. The relationship between Helicobacter pylori seropositivity and COPD. Thorax. 2015 Oct;70(10):923-9. doi: 10.1136/thoraxjnl-2015-207059. Epub 2015 May 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Triamcinolone | Other / unclassified | 1200 ug | Inhaled |