NCT00000569

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,116

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 1993

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1993

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 1999

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 1999

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

5.7 years

First QC Date

October 27, 1999

Last Update Submit

October 30, 2019

Conditions

Lung DiseasesLung Diseases, ObstructiveChronic Obstructive Pulmonary Disease

Study Arms (2)

Triamcinolone

ACTIVE COMPARATOR

1200 micrograms of triamcinolone in daily divided doses

Drug: triamcinolone

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

triamcinoloneDRUG

1200 micrograms of triamcinolone in daily divided doses

Also known as: Azmacort
Triamcinolone
PlaceboOTHER

Placebo

Placebo

Eligibility Criteria

Age40 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Recent myocardial infarction
  • Alcoholism
  • Heart Failure
  • Insulin-dependent diabetes mellitus
  • Neuropsychiatric disorders
  • Used bronchodilators or oral or inhaled corticosteroids in previous year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 11136268BACKGROUND

  • Lung 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.

    PMID: 11136260BACKGROUND

  • Simmons 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.

    PMID: 10936115BACKGROUND

  • Tashkin 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.

    PMID: 15486373BACKGROUND

  • Scanlon 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.

    PMID: 15374846BACKGROUND

  • Eichenhorn 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.

    PMID: 12853502BACKGROUND

  • Sze 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.

    PMID: 26024688DERIVED

MeSH Terms

Conditions

Lung DiseasesLung Diseases, ObstructivePulmonary Disease, Chronic Obstructive

Interventions

TriamcinoloneTriamcinolone Acetonide

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • John Connett

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

September 1, 1993

Primary Completion

May 1, 1999

Study Completion

May 1, 1999

Last Updated

November 1, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share