Lung DiseasesPhase 3NCT00000568
Lung Health Study (LHS) I and III
A Phase 3 study testing smoking cessation and ipratropium in people with Lung Diseases and Lung Diseases, Obstructive, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Lung Diseases, Lung Diseases, Obstructive, Chronic Obstructive Pulmonary Disease
- What is being tested?
- smoking cessation and ipratropium
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1984to Jan 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Men and women who were cigarette smokers and between the ages of 35 and 60.
About this study
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.
Read the detailed description
BACKGROUND:
Chronic 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.
Epidemiological 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.
Another 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.
Although 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.
DESIGN NARRATIVE:
Lung Health Study I
Randomized 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.
Lung Health Study III
Beginning 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.
- Being tested
- smoking cessation, ipratropium
- Medical subject headings
- Lung Diseases, Lung Diseases, Obstructive, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smoking cessationBehavioural
ipratropiumDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 1999 (estimated)
- Study startSep 1984
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (71)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- John Connett, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000568
- Sponsor's protocol ID
- 206
- Status last verified
- Aug 2005
- First submitted
- 27 Oct 1999
- Last updated
- 14 Apr 2016
- Results posted
- No
Publications
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.
PubMed 8500310Lung Health Study Research Group: The Lung Health Study: Introduction. Controlled Clin Trials, 14(2):1S-2S, 1993.
Connett 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.
PubMed 8500311Connett 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.
PubMed 8500312Bjornson-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.
PubMed 8500313Rudick 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.
PubMed 8500314Hurd 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.
PubMed 2048801Tashkin 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.
PubMed 1736734Bjornson-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.
PubMed 8213303Buist 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.
PubMed 8404115Buist 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.
PubMed 8404077Istvan 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.
PubMed 8172174Anthonisen 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.
PubMed 7966841Gross NJ. The lung health study. Disappointment and triumph. JAMA. 1994 Nov 16;272(19):1539-41. No abstract available.
PubMed 7966848Enright 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.
PubMed 2048803
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Health Study (LHS) I and III
- ClinicalTrials.gov ID
- NCT00000568
- Acronym / sponsor ID
- 206
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1984
- Study completion
- Jan 2005
- First posted
- 28 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND:
Chronic 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.
Epidemiological 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.
Another 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.
Although 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.
DESIGN NARRATIVE:
Lung Health Study I
Randomized 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.
Lung Health Study III
Beginning 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| smoking cessation | Behavioural | – |
| ipratropium | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- Background: PubMed 8500310Durkin 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.
- BackgroundLung Health Study Research Group: The Lung Health Study: Introduction. Controlled Clin Trials, 14(2):1S-2S, 1993.
- Background: PubMed 8500311Connett 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.
- Background: PubMed 8500312Connett 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.
- Background: PubMed 8500313Bjornson-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.
- Background: PubMed 8500314Rudick 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.
- Background: PubMed 2048801Hurd 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.
- Background: PubMed 1736734Tashkin 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.
- Background: PubMed 8213303Bjornson-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.
- Background: PubMed 8404115Buist 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.
- Background: PubMed 8404077Buist 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.
- Background: PubMed 8172174Istvan 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.
Related trials for Lung Diseases
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
RecruitingEarly Phase 1
Testing the Safety of Dapagliflozin Prior to Surgery for the Treatment of Patients With Stage IA Lung Adenocarcinoma
Lung Adenocarcinoma, Stage IA1 Lung Cancer American Joint Committee on Cancer (AJCC) v8
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
RecruitingPhase 3
A Study to Learn About the Study Medicine Called PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)
Non-small Cell Carcinoma, Non-Small Cell Lung Cancer Metastatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Connett
University of Minnesota
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing smoking cessation and ipratropium in people with Lung Diseases and Lung Diseases, Obstructive, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000568, which also lists 71 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2016.