Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000569
Status:
COMPLETED
Last Update Posted:
2019-11-01
First Post:
1999-10-27
Brief Title:
Lung Health Study II
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
The Chronic Obstructive Pulmonary Disease Early Intervention Trial
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LHSII
Brief 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
Detailed 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 forced expiratory volume at one second 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 35 to 45 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
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 forced expiratory volume at one second 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 35 to 45 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5U01HL050267-03 | NIH | None | httpsreporternihgovquickSearch5U01HL050267-03 |