Pulmonary Disease, Chronic ObstructivePhase 3NCT02261350
Post-hospitalisation Nutritional Support and Gait Speed in COPD
A Phase 3 study testing Food fortification and Oral Nutritional Supplements in people with Pulmonary Disease, Chronic Obstructive and Respiratory Tract Diseases, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
To determine the feasibility of delivering different community nutritional interventions to chronic obstructive pulmonary disease (COPD) patients at moderate or severe risk of malnutrition following a hospitalisation for an acute exacerbation of COPD. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Respiratory Tract Diseases, Lung Diseases, Obstructive
- What is being tested?
- Food fortification and Oral Nutritional Supplements
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2014to Sep 2015
- Phase
- Phase 3
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to consent
- Patients at moderate or severe risk of malnutrition
- Adults over the age of 40
- Hospitalised with an AECOPD
Who cannot join
- Receiving long term parental or enteral nutrition
- Inability to swallow or difficulty liquids
- Lactose intolerance, galactosaemia, cow's milk protein allergy or intolerance
- Co-existing active cancer, progressive neurological condition or active GI disorder.
- Receiving palliative care with expectation of death within 3 months
- Cognitive dysfunction or unable to consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Hillingdon Hospital NHS Foundation Trust
Uxbridge, Middlesex, UB8 3NN
About this study
Official title: The Effect of Nutritional Support on Gait Speed Following Hospitalisation for Acute Exacerbation of COPD
To determine the feasibility of delivering different community nutritional interventions to chronic obstructive pulmonary disease (COPD) patients at moderate or severe risk of malnutrition following a hospitalisation for an acute exacerbation of COPD.
- Conditions
- Pulmonary Disease, Chronic Obstructive, Respiratory Tract Diseases, Lung Diseases, Obstructive, Bronchitis, Chronic, Pulmonary Emphysema
- Being tested
- Food fortification, Oral Nutritional Supplements
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Tract Diseases, Lung Diseases, Obstructive, Bronchitis, Chronic, Pulmonary Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food fortificationDietary supplement
Oral Nutritional SupplementsDietary supplement
Also called Fortisip Compact, Nutricia Clinical
| Study group | Role | What they receive |
|---|---|---|
| Food Fortification | Experimental | Food Fortification Receives: Dietary Supplement: Food fortification |
| Oral Nutritional Supplements | Experimental | Oral Nutritional Supplements - Fortisip Compact Receives: Dietary Supplement: Oral Nutritional Supplements |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in four-metre gait speed (m/s) following nutritional support
Measured: Change from baseline to 12 weeks
Secondary outcomes (3)
Change in weight (kg) following nutritional support
Measured: Change from baseline to 12 weeks
Change in fat free mass (kg) as measured by bioelectrical impedence following nutritional support
Measured: Change from baseline to 12 weeks
Change in fat free mass index (kg/m2) as measured by bioelectrical impedence following nutritional support
Measured: Change from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startJan 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, The Hillingdon Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- William Man, PhD FRCP, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261350
- Sponsor's protocol ID
- 2013LF004H
- Status last verified
- Oct 2015
- First submitted
- 8 May 2014
- Last updated
- 2 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nutritional Support on Gait Speed Following Hospitalisation for Acute Exacerbation of COPD
- ClinicalTrials.gov ID
- NCT02261350
- Acronym / sponsor ID
- 2013LF004H
- Conditions
- Pulmonary Disease, Chronic Obstructive, Respiratory Tract Diseases, Lung Diseases, Obstructive, Bronchitis, Chronic, Pulmonary Emphysema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Medical Research Council, The Hillingdon Hospitals NHS Foundation Trust
- Study start
- Jan 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 10 Oct 2014 (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.
To determine the feasibility of delivering different community nutritional interventions to chronic obstructive pulmonary disease (COPD) patients at moderate or severe risk of malnutrition following a hospitalisation for an acute exacerbation of COPD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Food Fortification | Experimental | Dietary Supplement: Food fortificationFood Fortification |
| Oral Nutritional Supplements | Experimental | Dietary Supplement: Oral Nutritional SupplementsOral Nutritional Supplements - Fortisip Compact |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ability to consent
- Patients at moderate or severe risk of malnutrition
- Adults over the age of 40
- Hospitalised with an AECOPD
Key exclusion criteria (6 listed)
- Receiving long term parental or enteral nutrition
- Inability to swallow or difficulty liquids
- Lactose intolerance, galactosaemia, cow's milk protein allergy or intolerance
- Co-existing active cancer, progressive neurological condition or active GI disorder.
- Receiving palliative care with expectation of death within 3 months
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 |
|---|---|---|
| Food fortification | Dietary supplement | Food Fortification |
| Oral Nutritional SupplementsAlso: Fortisip Compact, Nutricia Clinical | Dietary supplement | Oral Nutritional Supplements |
Primary outcome
Change in four-metre gait speed (m/s) following nutritional support
Time frame: Change from baseline to 12 weeks
3 secondary outcomes
Change in weight (kg) following nutritional support
Time frame: Change from baseline to 12 weeks
Change in fat free mass (kg) as measured by bioelectrical impedence following nutritional support
Time frame: Change from baseline to 12 weeks
Change in fat free mass index (kg/m2) as measured by bioelectrical impedence following nutritional support
Time frame: Change from baseline to 12 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 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.
William Man, PhD FRCP principal investigator
Royal Brompton & Harefield NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Food fortification and Oral Nutritional Supplements in people with Pulmonary Disease, Chronic Obstructive and Respiratory Tract Diseases, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
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 4 inclusion and 6 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 2 Nov 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 United Kingdom. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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. 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?
Change in four-metre gait speed (m/s) following nutritional support (time frame: Change from baseline to 12 weeks). 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 2 Nov 2015.