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A Randomized Placebo Controlled Trial of Low Dose Angiotensin Converting Enzyme Inhibitor to Prevent Pneumonia in Older People Who Require Tube Feeding Because of Neurological Dysphagia

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What is being tested

Angiotensin converting enzyme inhibitor (Lisinopril)

+ Placebo

Drug
Who is being recruted

Infections+2

+ Lung Diseases

+ Pneumonia

Over 60 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-ControlledPhase 4
Interventional
Study Start: September 2010
See protocol details

Summary

Principal SponsorChinese University of Hong Kong
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2010

Actual date on which the first participant was enrolled.

Background: Older people with neurological dysphagia are at risk of recurrent aspiration pneumonia. Angiotensin converting enzyme inhibitor (ACEI) has been shown to improve swallowing and cough reflexes which may protect dysphagic patients from aspiration pneumonia. Hypotheses: ACEI reduces the risk of pneumonia in older patients who are nasogastric tube fed because of dysphagia from cerebrovascular diseases. Design: Randomized placebo controlled trial Method: 302 older patients who have been tube fed for more than two weeks because of dysphagia secondary to cerebrovascular diseases are randomized to take half of lisinopril 5 mg or placebo tablet once daily for 26 weeks. The subjects will be recruited from medical wards in Prince of Wales and Shatin Hospitals, and from outpatients of geriatric or speech therapy clinics, who have had hospital stay in previous three months. The subjects are followed up at week 12 and 26. The primary outcome is the incidence rate of pneumonia as determined by pneumonic change on X ray and clinical criteria. The secondary outcomes are mortality rate, total episodes of pneumonia over 26 weeks, and swallowing ability defined by the Royal Brisbane Hospital Outcome Measure at week 12. Cost effectiveness analysis of public health care and personal health care costs will be performed. Intention to treat and log rank will be used to analyzed the group differences in outcomes. 60 subjects (30 in each trial group) recruited from medical inpatients at Prince of Wales Hospital will undergo swallowing videofluoscopy at baseline and week 12 follow-up.

Official TitleA Randomized Placebo Controlled Trial of Low Dose Angiotensin Converting Enzyme Inhibitor to Prevent Pneumonia in Older People Who Require Tube Feeding Because of Neurological Dysphagia
NCT02358642
Principal SponsorChinese University of Hong Kong
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

93 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

InfectionsLung DiseasesPneumoniaRespiratory Tract DiseasesRespiratory Tract Infections

Criteria

2 inclusion criteria required to participate
Tube fed for more than four weeks for reason of neurological dysphagia as recommended by a trained speech therapist;

clinical diagnosis of cerebrovascular diseases, confirmed by CT head scan. The reason for restricting the subjects to those with cerebrovascular disease is that previous studies which showed beneficial effects of ACEI on dysphagia were mostly based on stroke patients.

9 exclusion criteria prevent from participating
life expectancy less than six months;

live outside Shatin area;

systolic blood pressure less than 100 mm Hg;

known intolerance of ACEI;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Angiotensin converting enzyme inhibitor (Lisinopril), 2.5mg, nocte, 26 weeks

Group II

Placebo
Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Prince of Wales Hospital

Hong Kong, Hong KongOpen Prince of Wales Hospital in Google Maps
SuspendedOne Study Center