Drug to Prevent Pneumonia in the Tube Fed

NCT02358642 | Terminated Phase 4

• 1 other identifier: ACEI-RCT
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pneumonia; Neurological Dysphagia

Keywords

Rate of Pneumonia; Mortality rate

Outcome Measures

Primary Outcomes (1)

• Incidence rate of pneumonia

  week 26

Secondary Outcomes (1)

• Number of pneumonia episodes

  week 26

Study Arms (2)

Angiotensin converting enzyme inhibitor

EXPERIMENTAL

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

Drug: Angiotensin converting enzyme inhibitor (Lisinopril)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Angiotensin converting enzyme inhibitor (Lisinopril) DRUG

Angiotensin converting enzyme inhibitor

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• life expectancy less than six months;
• live outside Shatin area;
• systolic blood pressure less than 100 mm Hg;
• known intolerance of ACEI;
• existing use of ACEI or angiotensin receptor blockers;
• symptomatic chronic lung disease or cardiac failure;
• frequent withdrawal of enteral tube by patients;
• serum creatinine \>100 µmol/L;
• serum potassium \> 5.1 mmol/L.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Pneumonia

Interventions

Angiotensin-Converting Enzyme Inhibitors; Lisinopril

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Medicien and Therapeutics

Study Record Dates

• First Submitted: February 28, 2013
• First Posted: February 9, 2015
• Study Start: September 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 9, 2015

Record last verified: 2015-01

Locations

HK (1)