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Drug to Prevent Pneumonia in the Tube Fed

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ClinicalTrials.gov Identifier: NCT02358642
Recruitment Status : Terminated (The interim analysis suggested that low dose lisinopril given to be tube fed older patients with neuroligical dysphagia had increased mortality.)
First Posted : February 9, 2015
Last Update Posted : February 9, 2015
Sponsor:
Information provided by (Responsible Party):
Timothy Kwok, Chinese University of Hong Kong

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.


Condition or disease Intervention/treatment Phase
Pneumonia Neurological Dysphagia Drug: Angiotensin converting enzyme inhibitor (Lisinopril) Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : September 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Lisinopril

Arm Intervention/treatment
Experimental: Angiotensin converting enzyme inhibitor
Angiotensin converting enzyme inhibitor (Lisinopril), 2.5mg, nocte, 26 weeks
Drug: Angiotensin converting enzyme inhibitor (Lisinopril)
Placebo Comparator: Placebo
Placebo
Drug: Placebo



Primary Outcome Measures :
  1. Incidence rate of pneumonia [ Time Frame: week 26 ]

Secondary Outcome Measures :
  1. Number of pneumonia episodes [ Time Frame: week 26 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02358642


Locations
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Hong Kong
Prince of Wales Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong

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Responsible Party: Timothy Kwok, Department of Medicien and Therapeutics, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT02358642     History of Changes
Other Study ID Numbers: ACEI-RCT
First Posted: February 9, 2015    Key Record Dates
Last Update Posted: February 9, 2015
Last Verified: January 2015
Keywords provided by Timothy Kwok, Chinese University of Hong Kong:
Rate of Pneumonia
Mortality rate
Additional relevant MeSH terms:
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Deglutition Disorders
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Lisinopril
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors
Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs