Lung Health Study (LHS) I and III
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
In the Lung Health Study I, to determine the effects of Special Care, compared to Usual Care, on rate of decline in pulmonary function in a group of cigarette smokers identified as having mild abnormalities in pulmonary function. In the Lung Health Study III, to determine the long-term effects of smoking cessation and continued smoking, on cardiopulmonary morbidity, mortality, and the rate of decline in the one second forced expiratory volume (FEV1) in men and women with early chronic obstructive lung disease who have been followed prospectively for 12 to 15 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 1984
Longer than P75 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 1984
CompletedFirst Submitted
Initial submission to the registry
October 27, 1999
CompletedFirst Posted
Study publicly available on registry
October 28, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2005
CompletedApril 14, 2016
August 1, 2005
October 27, 1999
April 13, 2016
Conditions
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Related Publications (71)
Durkin DA, Kjelsberg MO, Buist AS, Connett JE, Owens GR. Recruitment of participants in the Lung Health Study, I: Description of methods. Control Clin Trials. 1993 Apr;14(2 Suppl):20S-37S. doi: 10.1016/0197-2456(93)90022-6.
PMID: 8500310BACKGROUNDLung Health Study Research Group: The Lung Health Study: Introduction. Controlled Clin Trials, 14(2):1S-2S, 1993.
BACKGROUNDConnett JE, Kusek JW, Bailey WC, O'Hara P, Wu M. Design of the Lung Health Study: a randomized clinical trial of early intervention for chronic obstructive pulmonary disease. Control Clin Trials. 1993 Apr;14(2 Suppl):3S-19S. doi: 10.1016/0197-2456(93)90021-5.
PMID: 8500311BACKGROUNDConnett JE, Bjornson-Benson WM, Daniels K. Recruitment of participants in the Lung Health Study, II: Assessment of recruiting strategies. Control Clin Trials. 1993 Apr;14(2 Suppl):38S-51S. doi: 10.1016/0197-2456(93)90023-7.
PMID: 8500312BACKGROUNDBjornson-Benson WM, Stibolt TB, Manske KA, Zavela KJ, Youtsey DJ, Buist AS. Monitoring recruitment effectiveness and cost in a clinical trial. Control Clin Trials. 1993 Apr;14(2 Suppl):52S-67S. doi: 10.1016/0197-2456(93)90024-8.
PMID: 8500313BACKGROUNDRudick C, Anthonisen NR, Manfreda J. Recruiting healthy participants for a large clinical trial. Control Clin Trials. 1993 Apr;14(2 Suppl):68S-79S. doi: 10.1016/0197-2456(93)90025-9.
PMID: 8500314BACKGROUNDHurd SS. Lung Health Study: pulmonary function testing. Am Rev Respir Dis. 1991 Jun;143(6):1211. doi: 10.1164/ajrccm/143.6.1211. No abstract available.
PMID: 2048801BACKGROUNDTashkin DP, Altose MD, Bleecker ER, Connett JE, Kanner RE, Lee WW, Wise R. The lung health study: airway responsiveness to inhaled methacholine in smokers with mild to moderate airflow limitation. The Lung Health Study Research Group. Am Rev Respir Dis. 1992 Feb;145(2 Pt 1):301-10. doi: 10.1164/ajrccm/145.2_Pt_1.301.
PMID: 1736734BACKGROUNDBjornson-Benson W, Nides M, Dolce J, Rand C, Lindgren P, O'Hara P, Buist AS. Nicotine gum use in the first year of the Lung Health Study. Addict Behav. 1993 Jul-Aug;18(4):491-502. doi: 10.1016/0306-4603(93)90066-i.
PMID: 8213303BACKGROUNDBuist AS, Connett JE, Miller RD, Kanner RE, Owens GR, Voelker HT. Chronic Obstructive Pulmonary Disease Early Intervention Trial (Lung Health Study). Baseline characteristics of randomized participants. Chest. 1993 Jun;103(6):1863-72. doi: 10.1378/chest.103.6.1863.
PMID: 8404115BACKGROUNDBuist AS, Connett JE. The Lung Health Study. Baseline characteristics of randomized participants. Chest. 1993 Jun;103(6):1644. doi: 10.1378/chest.103.6.1644a. No abstract available.
PMID: 8404077BACKGROUNDIstvan JA, Nides MA, Buist AS, Greene P, Voelker H. Salivary cotinine, frequency of cigarette smoking, and body mass index: findings at baseline in the Lung Health Study. Am J Epidemiol. 1994 Mar 15;139(6):628-36. doi: 10.1093/oxfordjournals.aje.a117052.
PMID: 8172174BACKGROUNDAnthonisen NR, Connett JE, Kiley JP, Altose MD, Bailey WC, Buist AS, Conway WA Jr, Enright PL, Kanner RE, O'Hara P, et al. Effects of smoking intervention and the use of an inhaled anticholinergic bronchodilator on the rate of decline of FEV1. The Lung Health Study. JAMA. 1994 Nov 16;272(19):1497-505.
PMID: 7966841BACKGROUNDGross NJ. The lung health study. Disappointment and triumph. JAMA. 1994 Nov 16;272(19):1539-41. No abstract available.
PMID: 7966848BACKGROUNDEnright PL, Johnson LR, Connett JE, Voelker H, Buist AS. Spirometry in the Lung Health Study. 1. Methods and quality control. Am Rev Respir Dis. 1991 Jun;143(6):1215-23. doi: 10.1164/ajrccm/143.6.1215.
PMID: 2048803BACKGROUNDKanner RE, Connett JE, Altose MD, Buist AS, Lee WW, Tashkin DP, Wise RA. Gender difference in airway hyperresponsiveness in smokers with mild COPD. The Lung Health Study. Am J Respir Crit Care Med. 1994 Oct;150(4):956-61. doi: 10.1164/ajrccm.150.4.7921469.
PMID: 7921469BACKGROUNDMurray RP, Connett JE, Lauger GG, Voelker HT. Error in smoking measures: effects of intervention on relations of cotinine and carbon monoxide to self-reported smoking. The Lung Health Study Research Group. Am J Public Health. 1993 Sep;83(9):1251-7. doi: 10.2105/ajph.83.9.1251.
PMID: 8363000BACKGROUNDO'Hara P, Grill J, Rigdon MA, Connett JE, Lauger GA, Johnston JJ. Design and results of the initial intervention program for the Lung Health Study. The Lung Health Study Research Group. Prev Med. 1993 May;22(3):304-15. doi: 10.1006/pmed.1993.1025.
PMID: 8327414BACKGROUNDNides MA, Rakos RF, Gonzales D, Murray RP, Tashkin DP, Bjornson-Benson WM, Lindgren P, Connett JE. Predictors of initial smoking cessation and relapse through the first 2 years of the Lung Health Study. J Consult Clin Psychol. 1995 Feb;63(1):60-9. doi: 10.1037//0022-006x.63.1.60.
PMID: 7896992BACKGROUNDBjornson W, Rand C, Connett JE, Lindgren P, Nides M, Pope F, Buist AS, Hoppe-Ryan C, O'Hara P. Gender differences in smoking cessation after 3 years in the Lung Health Study. Am J Public Health. 1995 Feb;85(2):223-30. doi: 10.2105/ajph.85.2.223.
PMID: 7856782BACKGROUNDEnright PL, Connett JE, Kanner RE, Johnson LR, Lee WW. Spirometry in the Lung Health Study: II. Determinants of short-term intraindividual variability. Am J Respir Crit Care Med. 1995 Feb;151(2 Pt 1):406-11. doi: 10.1164/ajrccm.151.2.7842199.
PMID: 7842199BACKGROUNDWise RA, Connett J, Kurnow K, Grill J, Johnson L, Kanner R, Enright P. Selection of spirometric measurements in a clinical trial, the Lung Health Study. Am J Respir Crit Care Med. 1995 Mar;151(3 Pt 1):675-81. doi: 10.1164/ajrccm.151.3.7881655.
PMID: 7881655BACKGROUNDNides M, Rand C, Dolce J, Murray R, O'Hara P, Voelker H, Connett J. Weight gain as a function of smoking cessation and 2-mg nicotine gum use among middle-aged smokers with mild lung impairment in the first 2 years of the Lung Health Study. Health Psychol. 1994 Jul;13(4):354-61. doi: 10.1037//0278-6133.13.4.354.
PMID: 7957014BACKGROUNDOwens GR: Lung Health Study: Assessing the Impact of Early Intervention. Monograph. Chronic Bronchitis: Time to Act, Strategies for Prevention and Intervention. From the Proceedings of the Boehringer Ingelheim Ireland Symposium. Killarney, Ireland, July 1988.
BACKGROUNDConnett JE, Lee WW. Estimation of the coefficient of variation from laboratory analysis of split specimens for quality control in clinical trials. Control Clin Trials. 1990 Feb;11(1):24-36. doi: 10.1016/0197-2456(90)90029-2.
PMID: 2157578BACKGROUNDOwens GR: Pulmonary Function Tests as Guides in the Differential Physiologic Comparisons of Obstructive Pulmonary Diseases. J Respir Dis, II(6):S23-S29, 1990.
BACKGROUNDTashkin DP, Rand C, Nides M, Simmons M, Wise R, Coulson AH, Li V, Gong H Jr. A nebulizer chronolog to monitor compliance with inhaler use. Am J Med. 1991 Oct 21;91(4A):33S-36S. doi: 10.1016/0002-9343(91)90260-5.
PMID: 1951401BACKGROUNDOwens GR. Public screening for lung disease: experience with the NIH Lung Health Study. Am J Med. 1991 Oct 21;91(4A):37S-40S. doi: 10.1016/0002-9343(91)90261-u.
PMID: 1835293BACKGROUNDRand CS, Wise RA, Nides M, Simmons MS, Bleecker ER, Kusek JW, Li VC, Tashkin DP. Metered-dose inhaler adherence in a clinical trial. Am Rev Respir Dis. 1992 Dec;146(6):1559-64. doi: 10.1164/ajrccm/146.6.1559.
PMID: 1456575BACKGROUNDNides MA, Tashkin DP, Simmons MS, Wise RA, Li VC, Rand CS. Improving inhaler adherence in a clinical trial through the use of the nebulizer chronolog. Chest. 1993 Aug;104(2):501-7. doi: 10.1378/chest.104.2.501.
PMID: 8339641BACKGROUNDWu MC, Lan KK, Connett JE. Use of surrogate information time for monitoring the effect of treatment on the change in a response variable in clinical trials. Stat Med. 1994 May 15;13(9):945-53. doi: 10.1002/sim.4780130905.
PMID: 8047746BACKGROUNDJohnson LR, Enright PL, Voelker HT, Tashkin DP. Volume spirometers need automated internal temperature sensors. Am J Respir Crit Care Med. 1994 Dec;150(6 Pt 1):1575-80. doi: 10.1164/ajrccm.150.6.7952617.
PMID: 7952617BACKGROUNDIstvan JA, Buist AS, Hess DL, Voelker H. Relationship of smoking cessation and nicotine gum use to salivary androstenedione and testosterone in middle-aged men. Metabolism. 1995 Jan;44(1):90-5. doi: 10.1016/0026-0495(95)90294-5.
PMID: 7854172BACKGROUNDMurray RP, Istvan JA, Voelker HT, Rigdon MA, Wallace MD. Level of involvement with alcohol and success at smoking cessation in the lung health study. J Stud Alcohol. 1995 Jan;56(1):74-82. doi: 10.15288/jsa.1995.56.74.
PMID: 7752637BACKGROUNDTashkin DP, Altose MD, Connett JE, et al and the Lung Health Study Research Group: Airway Hyperresponsiveness in "Irreversible" Chronic Obstructive Pulmonary Disease. In: Spector SL, (Ed). Provocation Testing in Clinical Practice. New York, Marcel Dekker, Inc. ,575-598, 1995.
BACKGROUNDMurray RP, Johnston JJ, Dolce JJ, Lee WW, O'Hara P. Social support for smoking cessation and abstinence: the Lung Health Study. Lung Health Study Research Group. Addict Behav. 1995 Mar-Apr;20(2):159-70. doi: 10.1016/s0306-4603(99)80001-x.
PMID: 7484310BACKGROUNDMurray RP, Bailey WC, Daniels K, Bjornson WM, Kurnow K, Connett JE, Nides MA, Kiley JP. Safety of nicotine polacrilex gum used by 3,094 participants in the Lung Health Study. Lung Health Study Research Group. Chest. 1996 Feb;109(2):438-45. doi: 10.1378/chest.109.2.438.
PMID: 8620719BACKGROUNDPope CA 3rd, Kanner RE. Acute effects of PM10 pollution on pulmonary function of smokers with mild to moderate chronic obstructive pulmonary disease. Am Rev Respir Dis. 1993 Jun;147(6 Pt 1):1336-40. doi: 10.1164/ajrccm/147.6_Pt_1.1336.
PMID: 8503541BACKGROUNDUtell MJ, Samet JM. Particulate air pollution and health. New evidence on an old problem. Am Rev Respir Dis. 1993 Jun;147(6 Pt 1):1334-5. doi: 10.1164/ajrccm/147.6_Pt_1.1334. No abstract available.
PMID: 8503540BACKGROUNDOwens G. Editorial: Obstructive, Occupational, and Environmental Diseases: Editorial Overview. Current Opinion in Pul Med, 1:73-75, 1995.
BACKGROUNDIstvan J, Murray R, Voelker H. The relationship between patterns of alcohol consumption and body weight. Lung Health Study Research Group. Int J Epidemiol. 1995 Jun;24(3):543-6. doi: 10.1093/ije/24.3.543.
PMID: 7672894BACKGROUNDRand CS, Nides M, Cowles MK, Wise RA, Connett J. Long-term metered-dose inhaler adherence in a clinical trial. The Lung Health Study Research Group. Am J Respir Crit Care Med. 1995 Aug;152(2):580-8. doi: 10.1164/ajrccm.152.2.7633711.
PMID: 7633711BACKGROUNDMurray RP, Istvan JA, Voelker HT. Does cessation of smoking cause a change in alcohol consumption? Evidence from the Lung Health Study. Subst Use Misuse. 1996 Jan;31(2):141-56. doi: 10.3109/10826089609045804.
PMID: 8834004BACKGROUNDCowles MK, Carlin BP, Conett JE: Bayesian Tobit Modeling of Longitudinal Ordinal Clinical Trial Compliance Data with Nonignorable Missingness. J Am Stat Assoc, 92(433):86-98, 1996.
BACKGROUNDSimmons MS, Nides MA, Rand CS, Wise RA, Tashkin DP. Trends in compliance with bronchodilator inhaler use between follow-up visits in a clinical trial. Chest. 1996 Apr;109(4):963-8. doi: 10.1378/chest.109.4.963.
PMID: 8635378BACKGROUNDKanner RE. Early intervention in chronic obstructive pulmonary disease. A review of the Lung Health Study results. Med Clin North Am. 1996 May;80(3):523-47. doi: 10.1016/s0025-7125(05)70452-1.
PMID: 8637302BACKGROUNDTashkin DP, Altose MD, Connett JE, Kanner RE, Lee WW, Wise RA. Methacholine reactivity predicts changes in lung function over time in smokers with early chronic obstructive pulmonary disease. The Lung Health Study Research Group. Am J Respir Crit Care Med. 1996 Jun;153(6 Pt 1):1802-11. doi: 10.1164/ajrccm.153.6.8665038.
PMID: 8665038BACKGROUNDMurray RP, Voelker HT, Rakos RF, Nides MA, McCutcheon VJ, Bjornson W. Intervention for relapse to smoking: the Lung Health Study restart programs. Addict Behav. 1997 Mar-Apr;22(2):281-6. doi: 10.1016/s0306-4603(96)00008-1.
PMID: 9113223BACKGROUNDBjornson W: Early Chronic Obstructive Pulmonary Disease: Results from the Lung Health Study. Am J Health Behav, 20(5):270-278, 1996.
BACKGROUNDWise RA, Enright PL, Connett JE, Anthonisen NR, Kanner RE, Lindgren P, O'Hara P, Owens GR, Rand CS, Tashkin DP. Effect of weight gain on pulmonary function after smoking cessation in the Lung Health Study. Am J Respir Crit Care Med. 1998 Mar;157(3 Pt 1):866-72. doi: 10.1164/ajrccm.157.3.9706076.
PMID: 9517604BACKGROUNDMurray RP, Istvan JA, Daniels K, Beaudoin CM. Alcohol and morbidity in the Lung Health Study. J Stud Alcohol. 1998 May;59(3):250-7. doi: 10.15288/jsa.1998.59.250.
PMID: 9598705BACKGROUNDO'Hara P, Connett JE, Lee WW, Nides M, Murray R, Wise R. Early and late weight gain following smoking cessation in the Lung Health Study. Am J Epidemiol. 1998 Nov 1;148(9):821-30. doi: 10.1093/oxfordjournals.aje.a009706.
PMID: 9801011BACKGROUNDThun MJ, Colditz GA. Invited commentary on "early and late weight gain following smoking cessation in the Lung Health Study". Am J Epidemiol. 1998 Nov 1;148(9):831-2. doi: 10.1093/oxfordjournals.aje.a009707. No abstract available.
PMID: 9801012BACKGROUNDScanlon PD, Connett JE, Waller LA, Altose MD, Bailey WC, Buist AS, Tashkin DP; Lung Health Study Research Group. Smoking cessation and lung function in mild-to-moderate chronic obstructive pulmonary disease. The Lung Health Study. Am J Respir Crit Care Med. 2000 Feb;161(2 Pt 1):381-90. doi: 10.1164/ajrccm.161.2.9901044.
PMID: 10673175BACKGROUNDIstvan JA, Lee WW, Buist AS, Connett JE. Relation of salivary cotinine to blood pressure in middle-aged cigarette smokers. Am Heart J. 1999 May;137(5):928-31. doi: 10.1016/s0002-8703(99)70418-7.
PMID: 10220643BACKGROUNDKanner RE, Connett JE, Williams DE, Buist AS. Effects of randomized assignment to a smoking cessation intervention and changes in smoking habits on respiratory symptoms in smokers with early chronic obstructive pulmonary disease: the Lung Health Study. Am J Med. 1999 Apr;106(4):410-6. doi: 10.1016/s0002-9343(99)00056-x.
PMID: 10225243BACKGROUNDSandford AJ, Chagani T, Weir TD, Connett JE, Anthonisen NR, Pare PD. Susceptibility genes for rapid decline of lung function in the lung health study. Am J Respir Crit Care Med. 2001 Feb;163(2):469-73. doi: 10.1164/ajrccm.163.2.2006158.
PMID: 11179124BACKGROUNDKanner RE, Anthonisen NR, Connett JE; Lung Health Study Research Group. Lower respiratory illnesses promote FEV(1) decline in current smokers but not ex-smokers with mild chronic obstructive pulmonary disease: results from the lung health study. Am J Respir Crit Care Med. 2001 Aug 1;164(3):358-64. doi: 10.1164/ajrccm.164.3.2010017.
PMID: 11500333BACKGROUNDMurray RP, Connett JE, Buist AS, Gerald LB, Eichenhorn MS. Experience of Black participants in the Lung Health Study smoking cessation intervention program. Nicotine Tob Res. 2001 Nov;3(4):375-82. doi: 10.1080/14622200110081435.
PMID: 11694205BACKGROUNDMurray RP, Gerald LB, Lindgren PG, Connett JE, Rand CS, Anthonisen NR. Characteristics of participants who stop smoking and sustain abstinence for 1 and 5 years in the Lung Health Study. Prev Med. 2000 May;30(5):392-400. doi: 10.1006/pmed.2000.0642.
PMID: 10845748BACKGROUNDAnthonisen NR, Connett JE, Enright PL, Manfreda J; Lung Health Study Research Group. Hospitalizations and mortality in the Lung Health Study. Am J Respir Crit Care Med. 2002 Aug 1;166(3):333-9. doi: 10.1164/rccm.2110093.
PMID: 12153966BACKGROUNDAnthonisen NR, Connett JE, Murray RP. Smoking and lung function of Lung Health Study participants after 11 years. Am J Respir Crit Care Med. 2002 Sep 1;166(5):675-9. doi: 10.1164/rccm.2112096.
PMID: 12204864BACKGROUNDConnett JE, Murray RP, Buist AS, Wise RA, Bailey WC, Lindgren PG, Owens GR; Lung Health Study Research Group. Changes in smoking status affect women more than men: results of the Lung Health Study. Am J Epidemiol. 2003 Jun 1;157(11):973-9. doi: 10.1093/aje/kwg083.
PMID: 12777360BACKGROUNDAnthonisen NR, Skeans MA, Wise RA, Manfreda J, Kanner RE, Connett JE; Lung Health Study Research Group. The effects of a smoking cessation intervention on 14.5-year mortality: a randomized clinical trial. Ann Intern Med. 2005 Feb 15;142(4):233-9. doi: 10.7326/0003-4819-142-4-200502150-00005.
PMID: 15710956BACKGROUNDSamet JM. Smoking kills: experimental proof from the Lung Health Study. Ann Intern Med. 2005 Feb 15;142(4):299-301. doi: 10.7326/0003-4819-142-4-200502150-00012. No abstract available.
PMID: 15710963BACKGROUNDMurray RP, Anthonisen NR, Connett JE, Wise RA, Lindgren PG, Greene PG, Nides MA. Effects of multiple attempts to quit smoking and relapses to smoking on pulmonary function. Lung Health Study Research Group. J Clin Epidemiol. 1998 Dec;51(12):1317-26. doi: 10.1016/s0895-4356(98)00120-6.
PMID: 10086826BACKGROUNDMurray RP, Nides MA, Istvan JA, Daniels K. Levels of cotinine associated with long-term ad-libitum nicotine polacrilex use in a clinical trial. Addict Behav. 1998 Jul-Aug;23(4):529-35. doi: 10.1016/s0306-4603(97)00073-7.
PMID: 9698981BACKGROUNDAnthonisen NR. Lung Health Study. Am Rev Respir Dis. 1989 Oct;140(4):871-2. doi: 10.1164/ajrccm/140.4.871. No abstract available.
PMID: 2529803BACKGROUNDObeidat M, Zhou G, Li X, Hansel NN, Rafaels N, Mathias R, Ruczinski I, Beaty TH, Barnes KC, Pare PD, Sin DD. The genetics of smoking in individuals with chronic obstructive pulmonary disease. Respir Res. 2018 Apr 10;19(1):59. doi: 10.1186/s12931-018-0762-7.
PMID: 29631575DERIVEDZafari Z, Sin DD, Postma DS, Lofdahl CG, Vonk J, Bryan S, Lam S, Tammemagi CM, Khakban R, Man SFP, Tashkin D, Wise RA, Connett JE, McManus B, Ng R, Hollander Z, Sadatsafavi M. Individualized prediction of lung-function decline in chronic obstructive pulmonary disease. CMAJ. 2016 Oct 4;188(14):1004-1011. doi: 10.1503/cmaj.151483. Epub 2016 Aug 2.
PMID: 27486205DERIVEDSze 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.
PMID: 26024688DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
John Connett
University of Minnesota
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Sponsor Type
- NIH
Study Record Dates
First Submitted
October 27, 1999
First Posted
October 28, 1999
Study Start
September 1, 1984
Study Completion
January 1, 2005
Last Updated
April 14, 2016
Record last verified: 2005-08