COPDNCT04947852
Efficacy of NIV Masks in COPD
A study testing Investigation Mask and Comparator Mask in people with COPD, run by Fisher and Paykel Healthcare at 1 site in New Zealand.
Trial summary
A randomized controlled pilot study to compare the efficacy and tolerability of a two different NIV masks on carbon dioxide in participants with stable chronic obstructive pulmonary disease (COPD) with chronic type II respiratory failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Investigation Mask and Comparator Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNew Zealand
- Study dates
- 28 Jul 2021to 17 Mar 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A doctor's diagnosis of COPD
- PtCO2 ≥45mmHg on transcutaneous monitor at baseline measure
- Oxygen saturation measured by pulse oximetry (SpO2) ≥85%
- Fits the study mask
- Can tolerate the therapy
Who cannot join
- FEV1/FVC ≥70%
- Body mass index >35
- Hypercapnia considered to be primarily due to Obesity Hypoventilation syndrome and/or Obstructive Sleep Apnea
- Any condition which makes NIV contra-indicated as per BTS guidelines based on clinical judgement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of NIV Masks in COPD Patients With Chronic Respiratory Failure: A Randomized Controlled Cross Over Pilot
A randomized controlled pilot study to compare the efficacy and tolerability of a two different NIV masks on carbon dioxide in participants with stable chronic obstructive pulmonary disease (COPD) with chronic type II respiratory failure.
- Conditions
- COPD
- Being tested
- Investigation Mask, Comparator Mask
- 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.
Investigation MaskDevice
Oronasal bilevel continuous positive airway pressure mask fitted by the investigational staff
Comparator MaskDevice
Oronasal bilevel continuous positive airway pressure mask fitted by the investigational staff
| Study group | Role | What they receive |
|---|---|---|
| Investigation Mask | Experimental | Bi Level CPAP Mask Receives: Device: Investigation Mask; Device: Comparator Mask |
| Comparator Mask | Active comparator | Bi Level CPAP Mask Receives: Device: Investigation Mask; Device: Comparator Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcutaneous Carbon Dioxide
mmHg
Measured: 60 minutes
Secondary outcomes (5)
Oxygen Saturation
Percentage
Measured: 60 minutes
Minute Ventilation
Litres
Measured: 60 minutes
Heart Rate
Beats per minute
Measured: 60 minutes
Respiratory Rate
Breaths per minute
Measured: 60 minutes
Borg Dyspnoea Score
1-6 Ranking, with 1 being best and 6 being worst
Measured: 60 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start28 Jul 2021
- Primary completion17 Mar 2022
- Study completion17 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Fisher and Paykel HealthcareThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alex Semprini, Principal investigator, Medical Research Institute of New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947852
- Sponsor's protocol ID
- CIA293
- Status last verified
- Mar 2022
- First submitted
- 24 Jun 2021
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of NIV Masks in COPD Patients With Chronic Respiratory Failure: A Randomized Controlled Cross Over Pilot
- ClinicalTrials.gov ID
- NCT04947852
- Acronym / sponsor ID
- CIA293
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 17 Mar 2022 (actual)
- Study completion
- 17 Mar 2022 (actual)
- First posted
- 1 Jul 2021 (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.
A randomized controlled pilot study to compare the efficacy and tolerability of a two different NIV masks on carbon dioxide in participants with stable chronic obstructive pulmonary disease (COPD) with chronic type II respiratory failure.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigation Mask | Experimental | Device: Investigation Mask, Device: Comparator MaskBi Level CPAP Mask |
| Comparator Mask | Active comparator | Device: Investigation Mask, Device: Comparator MaskBi Level CPAP Mask |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A doctor's diagnosis of COPD
- PtCO2 ≥45mmHg on transcutaneous monitor at baseline measure
- Oxygen saturation measured by pulse oximetry (SpO2) ≥85%
- Fits the study mask
- Can tolerate the therapy
Key exclusion criteria (4 listed)
- FEV1/FVC ≥70%
- Body mass index >35
- Hypercapnia considered to be primarily due to Obesity Hypoventilation syndrome and/or Obstructive Sleep Apnea
- Any condition which makes NIV contra-indicated as per BTS guidelines based on clinical judgement
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 |
|---|---|---|
| Investigation MaskOronasal bilevel continuous positive airway pressure mask fitted by the investigational staff | Device | Comparator Mask, Investigation Mask |
| Comparator MaskOronasal bilevel continuous positive airway pressure mask fitted by the investigational staff | Device | Comparator Mask, Investigation Mask |
Primary outcome
Transcutaneous Carbon Dioxide
Time frame: 60 minutes
mmHg
5 secondary outcomes
Oxygen Saturation
Time frame: 60 minutes
Minute Ventilation
Time frame: 60 minutes
Heart Rate
Time frame: 60 minutes
Respiratory Rate
Time frame: 60 minutes
Borg Dyspnoea Score
Time frame: 60 Minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Individual participant dataSharing planned: No. There is no plan to make IPD available.
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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.
Alex Semprini principal investigator
Medical Research Institute of New Zealand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigation Mask and Comparator Mask in people with COPD, run by Fisher and Paykel Healthcare at 1 site in New Zealand.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 18 Mar 2022. 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 New Zealand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Transcutaneous Carbon Dioxide (time frame: 60 minutes). 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 18 Mar 2022.