Lung DiseasesPhase 3LHSIINCT00000569
Lung Health Study II
A Phase 3 study testing triamcinolone in people with Lung Diseases and Lung Diseases, Obstructive, run by University of Minnesota.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 69 years
- Conditions the study is for
- Lung Diseases, Lung Diseases, Obstructive, Chronic Obstructive Pulmonary Disease
- What is being tested?
- triamcinolone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,116 participants
- Where
- No sites listed yet
- Study dates
- Sep 1993to May 1999
- 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 40 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously participated in or screened for the Lung Health Study I
- Ages 40 to 69
- Forced expiratory volume at one second (FEV1)/forced vital capacity(FVC) < 70 percent
- Forced expiratory volume at one second (FEV1) 30 to 90 percent predicted.
- Exclusions:
- Cancer
Show all 12Show fewer
- Recent myocardial infarction
- Alcoholism
- Heart Failure
- Insulin-dependent diabetes mellitus
- Neuropsychiatric disorders
- Used bronchodilators or oral or inhaled corticosteroids in previous year
Who cannot join
None listed.
About this study
Official title: The Chronic Obstructive Pulmonary Disease Early Intervention Trial
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.
Read the 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 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.
- Being tested
- triamcinolone, Placebo
- 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.
triamcinoloneDrug
Also called Azmacort
1200 micrograms of triamcinolone in daily divided doses
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Triamcinolone | Active comparator | 1200 micrograms of triamcinolone in daily divided doses Receives: Drug: triamcinolone |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
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 1993
- Primary completionMay 1999
- Study completionMay 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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 University of MinnesotaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,116 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- John Connett, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000569
- Sponsor's protocol ID
- 9109M04382
- Other IDs
- 5U01HL050267-03
- Acronym
- LHSII
- Status last verified
- Oct 2019
- First submitted
- 27 Oct 1999
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Mapp CE. Inhaled glucocorticoids in chronic obstructive pulmonary disease. N Engl J Med. 2000 Dec 28;343(26):1960-1. doi: 10.1056/NEJM200012283432609. No abstract available.
PubMed 11136268Lung Health Study Research Group; Wise R, Connett J, Weinmann G, Scanlon P, Skeans M. Effect of inhaled triamcinolone on the decline in pulmonary function in chronic obstructive pulmonary disease. N Engl J Med. 2000 Dec 28;343(26):1902-9. doi: 10.1056/NEJM200012283432601.
PubMed 11136260Simmons MS, Nides MA, Rand CS, Wise RA, Tashkin DP. Unpredictability of deception in compliance with physician-prescribed bronchodilator inhaler use in a clinical trial. Chest. 2000 Aug;118(2):290-5. doi: 10.1378/chest.118.2.290.
PubMed 10936115Tashkin DP, Murray HE, Skeans M, Murray RP. Skin manifestations of inhaled corticosteroids in COPD patients: results from Lung Health Study II. Chest. 2004 Oct;126(4):1123-33. doi: 10.1016/S0012-3692(15)31287-3.
PubMed 15486373Scanlon PD, Connett JE, Wise RA, Tashkin DP, Madhok T, Skeans M, Carpenter PC, Bailey WC, Buist AS, Eichenhorn M, Kanner RE, Weinmann G; Lung Health Study Research Group. Loss of bone density with inhaled triamcinolone in Lung Health Study II. Am J Respir Crit Care Med. 2004 Dec 15;170(12):1302-9. doi: 10.1164/rccm.200310-1349OC. Epub 2004 Sep 16.
PubMed 15374846Eichenhorn MS, Wise RA, Madhok TC, Gerald LB, Bailey WC, Tashkin DP, Scanlon PD; Lung Health Study Research Group. Lack of long-term adverse adrenal effects from inhaled triamcinolone: Lung Health Study II. Chest. 2003 Jul;124(1):57-62. doi: 10.1378/chest.124.1.57.
PubMed 12853502Sze 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.
PubMed 26024688
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Chronic Obstructive Pulmonary Disease Early Intervention Trial
- ClinicalTrials.gov ID
- NCT00000569
- Acronym / sponsor ID
- LHSII / 9109M04382
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,116 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 1993
- Primary completion
- May 1999 (actual)
- Study completion
- May 1999 (actual)
- 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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triamcinolone | Active comparator | Drug: triamcinolone1200 micrograms of triamcinolone in daily divided doses |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Previously participated in or screened for the Lung Health Study I
- Ages 40 to 69
- Forced expiratory volume at one second (FEV1)/forced vital capacity(FVC) < 70 percent
- Forced expiratory volume at one second (FEV1) 30 to 90 percent predicted.
- Cancer
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| triamcinoloneAlso: Azmacort1200 micrograms of triamcinolone in daily divided doses | Drug | Triamcinolone |
| PlaceboPlacebo | Other | Placebo |
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 1 Nov 2019.
- Background: PubMed 11136268Mapp CE. Inhaled glucocorticoids in chronic obstructive pulmonary disease. N Engl J Med. 2000 Dec 28;343(26):1960-1. doi: 10.1056/NEJM200012283432609. No abstract available.
- Background: PubMed 11136260Lung Health Study Research Group; Wise R, Connett J, Weinmann G, Scanlon P, Skeans M. Effect of inhaled triamcinolone on the decline in pulmonary function in chronic obstructive pulmonary disease. N Engl J Med. 2000 Dec 28;343(26):1902-9. doi: 10.1056/NEJM200012283432601.
- Background: PubMed 10936115Simmons MS, Nides MA, Rand CS, Wise RA, Tashkin DP. Unpredictability of deception in compliance with physician-prescribed bronchodilator inhaler use in a clinical trial. Chest. 2000 Aug;118(2):290-5. doi: 10.1378/chest.118.2.290.
- Background: PubMed 15486373Tashkin DP, Murray HE, Skeans M, Murray RP. Skin manifestations of inhaled corticosteroids in COPD patients: results from Lung Health Study II. Chest. 2004 Oct;126(4):1123-33. doi: 10.1016/S0012-3692(15)31287-3.
- Background: PubMed 15374846Scanlon PD, Connett JE, Wise RA, Tashkin DP, Madhok T, Skeans M, Carpenter PC, Bailey WC, Buist AS, Eichenhorn M, Kanner RE, Weinmann G; Lung Health Study Research Group. Loss of bone density with inhaled triamcinolone in Lung Health Study II. Am J Respir Crit Care Med. 2004 Dec 15;170(12):1302-9. doi: 10.1164/rccm.200310-1349OC. Epub 2004 Sep 16.
- Background: PubMed 12853502Eichenhorn MS, Wise RA, Madhok TC, Gerald LB, Bailey WC, Tashkin DP, Scanlon PD; Lung Health Study Research Group. Lack of long-term adverse adrenal effects from inhaled triamcinolone: Lung Health Study II. Chest. 2003 Jul;124(1):57-62. doi: 10.1378/chest.124.1.57.
- Derived from this study: PubMed 26024688Sze 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.
- Individual participant dataSharing planned: No
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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 principal investigator
University of Minnesota
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing triamcinolone in people with Lung Diseases and Lung Diseases, Obstructive, run by University of Minnesota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. 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 1 Nov 2019. 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. Some participants in this study may receive a placebo. 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 NCT00000569, which also lists 7 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 1 Nov 2019.