We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Lung Health Study (LHS) I and III

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00000568
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : April 14, 2016
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Lung Diseases Lung Diseases, Obstructive Chronic Obstructive Pulmonary Disease Behavioral: smoking cessation Drug: ipratropium Phase 3

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
Study Start Date : September 1984
Estimated Study Completion Date : January 2005
Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Men and women who were cigarette smokers and between the ages of 35 and 60.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000568

Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
OverallOfficial: John Connett University of Minnesota - Clinical and Translational Science Institute
More Information

The Lung Health Study: Design of the Trial and Recruitment of Participants. Controlled Clin Trials, 14(2):1S-83S, 1993.
Lung Health Study Research Group: The Lung Health Study: Introduction. Controlled Clin Trials, 14(2):1S-2S, 1993.
Owens 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.
Owens GR: Pulmonary Function Tests as Guides in the Differential Physiologic Comparisons of Obstructive Pulmonary Diseases. J Respir Dis, II(6):S23-S29, 1990.
Tashkin 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.
Owens G. Editorial: Obstructive, Occupational, and Environmental Diseases: Editorial Overview. Current Opinion in Pul Med, 1:73-75, 1995.
Cowles 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.
Bjornson W: Early Chronic Obstructive Pulmonary Disease: Results from the Lung Health Study. Am J Health Behav, 20(5):270-278, 1996.

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: LHS
NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00000568     History of Changes
Other Study ID Numbers: 206
First Posted: October 28, 1999    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: August 2005

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action