Emphysema: Physiologic Effects of Nutritional Support

Chronic Obstructive Pulmonary Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000573
• Other study ID #: 211
• Secondary ID: R01HL033269
• Status: Completed
• Phase: Phase 2
• First received: October 27, 1999
• Last updated: May 12, 2016
• Start date: January 1990
• Est. completion date: November 2005

Study information

• Verified date: April 2002
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

BACKGROUND:

Chronic obstructive pulmonary disease is a major health problem and a leading cause for hospital admission in the United States. A severe form of chronic obstructive pulmonary disease that is accompanied by weight loss is commonly referred to as pulmonary cachexia. Studies in the 1960s demonstrated associations in chronic obstructive pulmonary disease patients between weight loss, low FEV1, and early mortality. This observation was strengthened by a retrospective analysis of the Intermittent Positive Pressure Breathing Trial data that suggested malnutrition was an independent predictor of outcome in men with chronic obstructive pulmonary disease. The underlying basis relating malnutrition to adverse outcome in chronic obstructive pulmonary disease was unknown, although there was a large body of information indicating that pulmonary cachexia was associated with respiratory muscle atrophy, myofibrillar substrate depletion, and impaired skeletal and respiratory muscle function. The primary question was whether the nutrition-related functional deficits observed in underweight patients could be reversed.

The first three years of the study supported a pilot project of oral nutrition therapy in malnourished chronic obstructive pulmonary disease patients.

DESIGN NARRATIVE:

All subjects underwent intubation during the initial testing interval and subsequently underwent dietary counseling and oral nutritional supplement during a two-month stabilization phase. Subjects who demonstrated adequate weight gain defined as achievement of more than 90 percent of ideal body weight or who were unable to tolerate intubation were eliminated from further investigation. Eligible subjects were randomized to either ENS or to dietary counseling only. Subjects randomized to ENS received enteral supplementation with Osmolite delivered by continuous infusion pump. Feedings were continuous or nocturnal for sixteen weeks in order to deliver a caloric intake of 1.7 times the resting energy value. Following the intervention phase, all subjects were maintained on dietary counseling on a monthly basis with oral nutritional supplements. Outcome variables were measured before and after the stabilization phase, at eight and sixteen weeks during the intervention phase, and at eight and sixteen weeks during the post-intervention phase. The primary outcome variable was muscle strength and its effect on exercise performance, dyspnea, and quality of life. Secondary outcome variables included morbidity and mortality. The grant was extended through November 1995 for data analysis.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years
• Eligibility: Men and women with uncomplicated stable chronic obstructive pulmonary disease.

Study Design

Allocation: Randomized

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Emphysema
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Emphysema

Intervention

Procedure:
• enteral nutrition

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & 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. — View Citation