PneumoniaPhase 4NCT02358642
Drug to Prevent Pneumonia in the Tube Fed
A Phase 4 study testing Angiotensin converting enzyme inhibitor (Lisinopril) in people with Pneumonia and Neurological Dysphagia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Pneumonia, Neurological Dysphagia
- What is being tested?
- Angiotensin converting enzyme inhibitor (Lisinopril)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteHong Kong
- Study dates
- Sep 2010to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- frequent withdrawal of enteral tube by patients;
- serum creatinine >100 µmol/L;
- serum potassium > 5.1 mmol/L.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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
- Being tested
- Angiotensin converting enzyme inhibitor (Lisinopril), Placebo
- Keywords
- Rate of Pneumonia, Mortality rate
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiotensin converting enzyme inhibitor (Lisinopril)Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Angiotensin converting enzyme inhibitor | Experimental | Angiotensin converting enzyme inhibitor (Lisinopril), 2.5mg, nocte, 26 weeks Receives: Drug: Angiotensin converting enzyme inhibitor (Lisinopril) |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of pneumonia
Measured: week 26
Secondary outcomes (1)
Number of pneumonia episodes
Measured: week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study startSep 2010
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: The interim analysis suggested that low dose lisinopril given to be tube fed older patients with neuroligical dysphagia had increased mortality.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Kwok, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358642
- Sponsor's protocol ID
- ACEI-RCT
- Status last verified
- Jan 2015
- First submitted
- 28 Feb 2013
- Last updated
- 9 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02358642
- Acronym / sponsor ID
- ACEI-RCT
- Conditions
- Pneumonia, Neurological Dysphagia
- Keywords
- Rate of Pneumonia, Mortality rate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The interim analysis suggested that low dose lisinopril given to be tube fed older patients with neuroligical dysphagia had increased mortality.
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 9 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Angiotensin converting enzyme inhibitor | Experimental | Drug: Angiotensin converting enzyme inhibitor (Lisinopril)Angiotensin converting enzyme inhibitor (Lisinopril), 2.5mg, nocte, 26 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angiotensin converting enzyme inhibitor (Lisinopril) | Drug | Angiotensin converting enzyme inhibitor |
| Placebo | Drug | Placebo |
Primary outcome
Incidence rate of pneumonia
Time frame: week 26
1 secondary outcome
Number of pneumonia episodes
Time frame: week 26
Results and safety
The study was stopped early (reason given: The interim analysis suggested that low dose lisinopril given to be tube fed older patients with neuroligical dysphagia had increased mortality.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Angiotensin converting enzyme inhibitor (Lisinopril) in people with Pneumonia and Neurological Dysphagia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The interim analysis suggested that low dose lisinopril given to be tube fed older patients with neuroligical dysphagia had increased mortality.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of pneumonia (time frame: week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2015.