Chronic Obstructive Pulmonary DiseaseNCT02108925
Effect of Oxygen Supplementation During Exercise in Chronic Obstructive Pulmonary Disease Patients
A study testing Oxygen in people with Chronic Obstructive Pulmonary Disease and Hypoxia, run by LHL Helse at 1 site in Norway.
Trial summary
The project will test the hypothesis that lung ventilation during exercise is unaffected by oxygen supplementation. In addition, the acute effect of oxygen supplementation on dyspnoea, heart rate and blood pressure will be studied. Read more about this study
- Who is it for?
- Ages 20 to 95 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Hypoxia
- What is being tested?
- Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2014to Mar 2018
- 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 20 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic obstructive pulmonary disease
Who cannot join
- No exacerbation
- No active heart disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oxygen Supply and Ventilation During Physical Exercise in Patients With Chronic Obstructive Pulmonary Disease
The project will test the hypothesis that lung ventilation during exercise is unaffected by oxygen supplementation. In addition, the acute effect of oxygen supplementation on dyspnoea, heart rate and blood pressure will be studied.
- Conditions
- Chronic Obstructive Pulmonary Disease, Hypoxia
- Being tested
- Oxygen
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygenDrug
supplementary oxygen during exercise
| Study group | Role | What they receive |
|---|---|---|
| Supplementary oxygen | Experimental | Study subjects receive, in randomized order, either supplementary 30% oxygen or air (21% Oxygen) from a gas tight bag Receives: Drug: Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary ventilation
Measured: 1 hour
Secondary outcomes (3)
Dyspnoea
Measured: 1 hour
Heart rate
Measured: 1 hour
Blood pressure
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2016
- Study completionMar 2018
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
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- LHL Helse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Edvardsen, PhD, Principal investigator, LHL Helse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02108925
- Sponsor's protocol ID
- 2013/2396
- Status last verified
- Mar 2018
- First submitted
- 7 Apr 2014
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen Supply and Ventilation During Physical Exercise in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02108925
- Acronym / sponsor ID
- 2013/2396
- Conditions
- Chronic Obstructive Pulmonary Disease, Hypoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- LHL HelseUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 9 Apr 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.
The project will test the hypothesis that lung ventilation during exercise is unaffected by oxygen supplementation. In addition, the acute effect of oxygen supplementation on dyspnoea, heart rate and blood pressure will be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supplementary oxygen | Experimental | Drug: OxygenStudy subjects receive, in randomized order, either supplementary 30% oxygen or air (21% Oxygen) from a gas tight bag |
Who may qualify
- Ages
- 20 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic obstructive pulmonary disease
Key exclusion criteria (2 listed)
- No exacerbation
- No active heart disease
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 |
|---|---|---|
| Oxygensupplementary oxygen during exercise | Drug | Supplementary oxygen |
Primary outcome
Pulmonary ventilation
Time frame: 1 hour
3 secondary outcomes
Dyspnoea
Time frame: 1 hour
Heart rate
Time frame: 1 hour
Blood pressure
Time frame: 1 hour
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 23 Mar 2018.
- 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.
Anne Edvardsen, PhD principal investigator
LHL Helse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen in people with Chronic Obstructive Pulmonary Disease and Hypoxia, run by LHL Helse at 1 site in Norway.
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 1 inclusion and 2 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 23 Mar 2018. 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 Norway. 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?
Pulmonary ventilation (time frame: 1 hour). 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 23 Mar 2018.