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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||93 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
Experimental: Angiotensin converting enzyme inhibitor
Angiotensin converting enzyme inhibitor (Lisinopril), 2.5mg, nocte, 26 weeks
Drug: Angiotensin converting enzyme inhibitor (Lisinopril)
Placebo Comparator: Placebo
- Incidence rate of pneumonia [ Time Frame: week 26 ]
- Number of pneumonia episodes [ Time Frame: week 26 ]
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
|Prince of Wales Hospital|
|Hong Kong, Hong Kong|