NCT00000573

Brief Summary

To determine if enteral nutrition support (ENS) restores normal body weight and improves muscle strength, exercise performance, sensation of dyspnea, and quality of life in malnourished patients with chronic obstructive pulmonary disease.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Jan 1990

Longer than P75 for phase_2

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

January 1, 1990

Completed
9.8 years 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
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

May 13, 2016

Status Verified

April 1, 2002

First QC Date

October 27, 1999

Last Update Submit

May 12, 2016

Conditions

Interventions

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Men and women with uncomplicated stable chronic obstructive pulmonary disease.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (1)

  • de Godoy I, Donahoe M, Calhoun WJ, Mancino J, Rogers RM. Elevated TNF-alpha production by peripheral blood monocytes of weight-losing COPD patients. Am J Respir Crit Care Med. 1996 Feb;153(2):633-7. doi: 10.1164/ajrccm.153.2.8564110.

    PMID: 8564110BACKGROUND

MeSH Terms

Conditions

EmphysemaLung DiseasesLung Diseases, ObstructivePulmonary Disease, Chronic Obstructive

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract DiseasesChronic DiseaseDisease Attributes

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

January 1, 1990

Study Completion

November 1, 2005

Last Updated

May 13, 2016

Record last verified: 2002-04