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Trial NCT00000569

Resource URI: http://static.linkedct.org/resource/trials/NCT00000569
linkedct:brief_title Lung Health Study II
linkedct:condition <http://static.linkedct.org/resource/condition/2817>
linkedct:condition <http://static.linkedct.org/resource/condition/7483>
linkedct:condition <http://static.linkedct.org/resource/condition/7486>
linkedct:criteria Men and women, ages 40 to 69, with FEV1/FVC 70 percent and FEV1 that was 30 to 90 percent predicted.
linkedct:description BACKGROUND: Chronic obstructive pulmonary disease (COPD), the fourth leading cause of death in the United States and a major cause of morbidity, is a spectrum of chronic lung diseases including clinical diagnoses of chronic bronchitis, emphysema, and combinations of both. Varying degrees of bronchoreactivity occur over the entire spectrum. Asthma and COPD have many features in common. Distinction is usually dependent on clinical features and clinical course. The diagnosis of asthma will not exclude a patient from the designation of COPD for this study, although criteria for exclusion include recent (within six months) use of inhaled or oral steroid with the intent of excluding most of those who are clearly predominantly bronchospastic. The morbid anatomy of COPD is well described and includes many features of acute and chronic inflammation. There is well supported evidence in the literature that this inflammatory process may be an important pathogenetic mechanism in the development of emphysema. On this basis, the rationale for the use of corticosteroids is well justified. There are various published studies suggesting that inhaled steroids reduce bronchial lavage markers of inflammation, variously influence short-term bronchial hyperreactivity, improve lung function acutely or short-term, and slow rate of decline in lung function. Most studies have asked for improvement rather than stability. However, despite the studies which do not support these contentions and the lack of long-term information, inhaled steroids in COPD are becoming widely used in clinical practice. It was the intent of this clinical trial to assess the long-term efficacy of this treatment before such therapy became an accepted community practice, making it impractical or impossible to conduct a clinical trial. DESIGN NARRATIVE: Subjects were recruited from the Lung Health Study I and randomized to 1200 micrograms of triamcinolone in daily divided doses or to placebo. Pulmonary function was evaluated every six months. Bronchial activity was tested at baseline, at nine months, and at three-and-a-half years using a methacholine inhalation challenge. Mean duration of follow-up was 40 months. The primary outcome measure was the rate of decline in pulmonary function as assessed by the post-bronchodilator FEV1 value. Other outcome measures included death, respiratory symptoms, quality of life, side-effects and toxicity, adherence, bronchial hyperreactivity, atopic status, and smoking status. Recruitment was initiated in November 1994 and ended November 28, 1995 to allow 3.5 to 4.5 years of follow-up through April, 1999. The investigators initiated a dose monitor (puff counter) protocol at nine of the centers among the fair to satisfactory compliers (4 to 9 puffs versus the ideal of 12 puffs per day) to test whether a memory aid would enhance inhaler compliance. Consenting participants were randomized to Group 1 who could see the display on the puff counter for 12 months or to Group 2 who had no counter for three months, a counter that recorded but did not display for three months, and a counter with display for six months. There were a bone densitometry and adrenal suppression ancillary studies, funded by Rhone-Poulenc-Rorer, to assess the effect of inhaled corticosteroids on bone density and adrenal function.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 69 Years
linkedct:eligibility_minimum_age 40 Years
linkedct:end_date August 2000
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000569
rdfs:label Trial NCT00000569
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000569
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 207
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/28687>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000569>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/18011>
linkedct:reference <http://static.linkedct.org/resource/reference/23768>
linkedct:reference <http://static.linkedct.org/resource/reference/24171>
linkedct:reference <http://static.linkedct.org/resource/reference/7813>
linkedct:reference <http://static.linkedct.org/resource/reference/8890>
linkedct:reference <http://static.linkedct.org/resource/reference/8892>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date September 1993
linkedct:study_design Treatment, Randomized, Placebo Control
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date March 2005