Chronic Obstructive Pulmonary DiseaseNCT03940040
High Flow Nasal Oxygen Versus Usual Care in COPD Pulmonary Rehabiliation
A study testing High flow nasal oxygen in people with Chronic Obstructive Pulmonary Disease, run by Changi General Hospital at 1 site in Singapore.
Trial summary
To compare the effects of high flow nasal oxygen with usual care during an outpatient 6-week pulmonary rehabilitation program after hospitalization for COPD exacerbation. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- High flow nasal oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSingapore
- Study dates
- 28 May 2019to Jun 2021
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 years and above
- Known diagnosis of COPD based on history AND spirometry demonstrating post bronchodilator FEV1/FVC ratio <0.7
- Currently admitted inpatient for an acute COPD exacerbation as the primary diagnosis
- Fit to participate in exercise therapy as determined by both physician and physiotherapist
- Has the mental capacity to follow instructions
- Experience shortness of breath on exertion
- Have decreased ability to carry out activities due to shortness of breath
- Willing to participate in the exercise program
Who cannot join
- Uncontrolled/ unstable medical conditions such as severe chronic heart failure that make exercise unsafe
- Pulmonary disorder other than COPD
- Physical conditions that preclude the ability to participate in exercise or may impair exercise performance.
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Changi General Hospital
Singapore, 529889
Yingjuan Mok, MBBS, 68502600, mok.yingjuan@singhealth.com.sg
Nur Shameerah Abdul Halim, 68502600, Nur_Shameerah@cgh.com.sg
About this study
Official title: Comparing the Effect of High Flow Nasal Oxygen With Usual Care on Pulmonary Rehabilitation in COPD Patients After an Acute Exacerbation; a Pilot Randomized Controlled Trial
To compare the effects of high flow nasal oxygen with usual care during an outpatient 6-week pulmonary rehabilitation program after hospitalization for COPD exacerbation.
Read the detailed description
This is a pilot randomized controlled trial to compare the effects of high flow nasal oxygen with usual care during an outpatient 6-week pulmonary rehabilitation program after hospitalization for COPD exacerbation.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Usual care, High flow nasal oxygen
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careOther
Usual Care
High flow nasal oxygenOther
High flow nasal oxygen
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Patients will under go usual care ( pulmonary rehabilitation on room air or with nasal oxygen supplementation) Receives: Other: Usual care |
| High flow nasal oxygen | Experimental | Patients will undergo pulmonary rehabilitation with high flow nasal oxygen Receives: Other: High flow nasal oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk distance
It is the maximum distance walked in 6 minutes
Measured: 6 weeks
Secondary outcomes (4)
COPD Assessment Test score
Chronic obstructive pulmonary disease assessment test (CAT) score
Measured: 3 weeks, 6 weeks and 1 month after completion of program
Hospital Anxiety Depression Scale
This scale has 2 subscale scores of 1) Depression 2) Anxiety. Scores of 0-7 = Normal, 8-10 = Borderline, 11-21 = Abnormal
Measured: 3 weeks, 6 weeks and 1 month after completion of program
Respiratory function test
It is a test of respiratory function
Measured: 3 weeks, 6 weeks and 1 month after completion of program
6-minute walk distance
It is the maximum distance walked in 6 minutes
Measured: 3 weeks and 1 month after completion of program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start28 May 2019
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yingjuan Mok, MBBS, Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940040
- Sponsor's protocol ID
- HFO_RCT
- Status last verified
- Oct 2020
- First submitted
- 5 May 2019
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effect of High Flow Nasal Oxygen With Usual Care on Pulmonary Rehabilitation in COPD Patients After an Acute Exacerbation; a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03940040
- Acronym / sponsor ID
- HFO_RCT
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- 28 May 2019 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 7 May 2019 (actual)
- 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 compare the effects of high flow nasal oxygen with usual care during an outpatient 6-week pulmonary rehabilitation program after hospitalization for COPD exacerbation.
Detailed description
This is a pilot randomized controlled trial to compare the effects of high flow nasal oxygen with usual care during an outpatient 6-week pulmonary rehabilitation program after hospitalization for COPD exacerbation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Usual carePatients will under go usual care ( pulmonary rehabilitation on room air or with nasal oxygen supplementation) |
| High flow nasal oxygen | Experimental | Other: High flow nasal oxygenPatients will undergo pulmonary rehabilitation with high flow nasal oxygen |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 21 years and above
- Known diagnosis of COPD based on history AND spirometry demonstrating post bronchodilator FEV1/FVC ratio <0.7
- Currently admitted inpatient for an acute COPD exacerbation as the primary diagnosis
- Fit to participate in exercise therapy as determined by both physician and physiotherapist
- Has the mental capacity to follow instructions
Key exclusion criteria (3 listed)
- Uncontrolled/ unstable medical conditions such as severe chronic heart failure that make exercise unsafe
- Pulmonary disorder other than COPD
- Physical conditions that preclude the ability to participate in exercise or may impair exercise performance.
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 |
|---|---|---|
| Usual careUsual Care | Other | Usual Care |
| High flow nasal oxygenHigh flow nasal oxygen | Other | High flow nasal oxygen |
Primary outcome
6-minute walk distance
Time frame: 6 weeks
It is the maximum distance walked in 6 minutes
4 secondary outcomes
COPD Assessment Test score
Time frame: 3 weeks, 6 weeks and 1 month after completion of program
Hospital Anxiety Depression Scale
Time frame: 3 weeks, 6 weeks and 1 month after completion of program
Respiratory function test
Time frame: 3 weeks, 6 weeks and 1 month after completion of program
6-minute walk distance
Time frame: 3 weeks and 1 month after completion of program
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Yingjuan Mok, MBBS principal investigator
Changi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High flow nasal oxygen in people with Chronic Obstructive Pulmonary Disease, run by Changi General Hospital at 1 site in Singapore.
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 8 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Oct 2020. 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 Singapore. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yingjuan Mok, MBS (68502600, mok.yingjuan@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walk distance (time frame: 6 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 8 Oct 2020.