Nctid:
NCT00000568
Payload:
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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."}, {"ReferencePMID"=>"10225243", "ReferenceType"=>"background", "ReferenceCitation"=>"Kanner 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."}, {"ReferencePMID"=>"11179124", "ReferenceType"=>"background", "ReferenceCitation"=>"Sandford 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."}, {"ReferencePMID"=>"11500333", "ReferenceType"=>"background", "ReferenceCitation"=>"Kanner 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."}, {"ReferencePMID"=>"11694205", "ReferenceType"=>"background", "ReferenceCitation"=>"Murray 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."}, {"ReferencePMID"=>"10845748", "ReferenceType"=>"background", "ReferenceCitation"=>"Murray 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."}, {"ReferencePMID"=>"12153966", "ReferenceType"=>"background", "ReferenceCitation"=>"Anthonisen 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."}, {"ReferencePMID"=>"12204864", "ReferenceType"=>"background", "ReferenceCitation"=>"Anthonisen 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."}, {"ReferencePMID"=>"12777360", "ReferenceType"=>"background", "ReferenceCitation"=>"Connett JE, Murray RP, Buist AS, Wise RA, Bailey WC, Lindgren PG, Owens GR; Lung Health Study Research Group. 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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."}, {"ReferencePMID"=>"9698981", "ReferenceType"=>"background", "ReferenceCitation"=>"Murray 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."}, {"ReferencePMID"=>"2529803", "ReferenceType"=>"background", "ReferenceCitation"=>"Anthonisen NR. Lung Health Study. Am Rev Respir Dis. 1989 Oct;140(4):871-2. doi: 10.1164/ajrccm/140.4.871. No abstract available."}, {"ReferencePMID"=>"29631575", "ReferenceType"=>"derived", "ReferenceCitation"=>"Obeidat 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."}, {"ReferencePMID"=>"27486205", "ReferenceType"=>"derived", "ReferenceCitation"=>"Zafari 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."}, {"ReferencePMID"=>"26024688", "ReferenceType"=>"derived", "ReferenceCitation"=>"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."}]}}, "DescriptionModule"=>{"BriefSummary"=>"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.\n\nIn 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.", "DetailedDescription"=>"BACKGROUND:\n\nChronic obstructive pulmonary disease (COPD) is a major cause of mortality and morbidity in the United States, affecting nearly 10 million persons. COPD accounts for 60,000 deaths yearly and ranks as the fourth leading cause of death. If current trends continue, it may become the nation's fourth or even third leading cause of death by the year 2000.\n\nEpidemiological studies consistently indicated that smoking was the over-whelming risk factor for accelerated decline in pulmonary function and subsequent development of COPD. Furthermore, evidence from several studies indicated that the rate of decline in pulmonary function approached a more normal rate of decline upon cessation of cigarette smoking.\n\nAnother presumed risk factor for accelerated decline in pulmonary function was the presence of hyperreactive airways, although it was not clear whether the mere presence of hyperreactive airways contributed to the accelerated decline, or whether the decline resulted from the reaction of the airways to various irritants over a long period of time. It is possible that if the hyperreactive airway was kept non-reactive by pharmacological means over a period of years, the expected abnormal decline might be lessened. This effect might be enhanced by the cessation of cigarette smoking.\n\nAlthough the evidence was strong that smoking and hyperreactive airways were risk factors for COPD, it had not been demonstrated whether removal of risk factors at a stage when mild dysfunction had already occurred would effectively modify the course of COPD.\n\nDESIGN NARRATIVE:\n\nLung Health Study I\n\nRandomized and controlled. Cigarette smokers with evidence of airways obstruction underwent baseline testing that included spirometric responses to isoproterenol and methacholine and were then randomly assigned to one of three groups: a no intervention or usual care group; a group receiving a smoking cessation program and bronchodilator therapy; a group receiving a smoking cessation program and a placebo bronchodilator. The placebo/bronchodilator therapy was double-blind. The smoking intervention consisted of an intensive 12-session smoking cessation program combining behavior modification and use of nicotine gum, with a continuing five-year maintenance program to minimize relapse. The bronchodilator consisted of ipratropium bromide prescribed three times daily, two puffs per time, from a metered-dose inhaler. All groups were followed yearly for five years. The primary endpoint was the rate of change of FEV1. Respiratory morbidity was a secondary endpoint. Recruitment began in November 1986 and was completed in January 1989. The clinical phase of the trial ended in April 1994. The study continues under contract N01-HR-46002 through September, 2004 for data analysis and dissemination of research results.\n\nLung Health Study III\n\nBeginning in fiscal year 1998, all surviving participants of LHS I are invited to participate in the long-term followup. The study will determine, using an intent-to-treat analysis, whether the LHS I smoking intervention significantly reduces the incidence of clinically important respiratory and cardiovascular disease over a 12- to 15-year period following study enrollment. The study will also estimate the magnitude of the effects of FEV1 and FVC on the risks of cardiovascular and respiratory morbidity and mortality, after controlling for smoking history. Studies will be conducted on the role of other factors such as gender, airways reactivity, weight gain, and co-morbidities in determining the rate of decline in pulmonary function and the risks of cardiovascular and respiratory morbidity and mortality. A determination will also be made as to whether the improvement in lung function and reduction in respiratory symptoms associated with smoking cessation result in improved health-related quality of life (HRQL) and less depression over an extended follow-up period. The LHS III, an investigator initiated long-term follow-up study, is not an NIH- defined clinical trial."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"60 years", "MinimumAge"=>"35 years", "StdAgeList"=>{"StdAge"=>["Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Men and women who were cigarette smokers and between the ages of 35 and 60."}, "IdentificationModule"=>{"NCTId"=>"NCT00000568", "BriefTitle"=>"Lung Health Study (LHS) I and III", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Heart, Lung, and Blood Institute (NHLBI)"}, "OrgStudyIdInfo"=>{"OrgStudyId"=>"206"}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"smoking cessation", "InterventionType"=>"Behavioral"}, {"InterventionName"=>"ipratropium", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"John Connett", "OverallOfficialAffiliation"=>"University of Minnesota"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Heart, Lung, and Blood Institute (NHLBI)", "LeadSponsorClass"=>"NIH"}}}}}}
