Chronic Obstructive Pulmonary Disease (COPD)Phase 4NCT02143609
Patients With Chronic Obstructive Pulmonary Disease at Altitude - Effect of Nocturnal Oxygen on Exercise Performance
A Phase 4 study testing oxygen in people with Chronic Obstructive Pulmonary Disease (COPD), run by University of Zurich at 1 site in Switzerland.
Trial summary
The purpose of this study is to investigate the effect of nocturnal oxygen therapy during a stay at moderate altitude on exercise performance of patients with chronic obstructive lung disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- oxygen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2014to 31 Oct 2014
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic obstructive pulmonary disease (COPD), GOLD grade 2-3
- residents at low altitude (<800 m)
Who cannot join
- unstable condition, COPD exacerbation
- mild (GOLD 1) or very severe COPD (GOLD 4)
- requirement for oxygen therapy at low altitude residence
- hypoventilation
- pulmonary hypertension
- more than mild or unstable cardiovascular disease
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- use of drugs that affect respiratory center drive
- internal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (>20 cigarettes per day), inability to perform 6 min walk test.
- previous intolerance to moderate altitude (<2600m).
- exposure to altitudes >1500m for >2 days within the last 4 weeks before the study.
- pregnant or nursing patients
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Pulmonary Division
Zurich, CH-8091
About this study
Official title: Patients With Chronic Obstructive Pulmonary Disease at Altitude - Effect of Nocturnal Oxygen Therapy on Exercise Performance
The purpose of this study is to investigate the effect of nocturnal oxygen therapy during a stay at moderate altitude on exercise performance of patients with chronic obstructive lung disease.
Read the detailed description
Patients with moderate to severe COPD living below 800 m, will be recruited to participate in a randomized cross-over field trial evaluating the hypothesis that exercise capacity during a 2 day sojourn at moderate altitude is improved by nocturnal oxygen therapy via a nasal cannula. Outcomes will be assessed during 2 days in Zurich (490 m, low altitude baseline), and during 2 days at St. Moritz Salastrains (2048 m).
- Being tested
- oxygen, sham oxygen (room air)
- Keywords
- airway disease, bronchitis, emphysema, lung
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxygenDrug
Also called Nocturnal oxygen via nasal cannula, 3 L/min, at 2048 m
Nocturnal nasal oxygen during stay at 2048 m
sham oxygen (room air)Drug
Also called Nocturnal nasal room air during stay at 2048 m
Sham oxygen (room air) via nasal cannula, 3 L/min, at 2048 m
| Study group | Role | What they receive |
|---|---|---|
| Oxygen | Active comparator | oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m Receives: Drug: oxygen; Drug: sham oxygen (room air) |
| Sham oxygen | Placebo comparator | sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m Receives: Drug: oxygen; Drug: sham oxygen (room air) |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 min walk distance
Difference in the distance walked in 6 min between the oxygen and sham oxygen period
Measured: Day 2 at 2048 m
Secondary outcomes (6)
6 min walk distance
Difference in the distance walked in 6 min between the oxygen and sham oxygen period
Measured: day 3 at 2048 m
Arterial blood gas analysis
Difference in arterial oxygen partial pressure, carbon dioxide partial pressure, and pH
Measured: Day 2 at 2048 m
Spirometry
Difference in spirometric variables between the oxygen and sham oxygen period
Measured: Day 2 at 2048 m
Perceived exertion
Difference in perceived exertion rated with the BORG CR10 scale at the end of the 6 min walk
Measured: Day 2 at 2048 m
Perceived exertion
Difference in perceived exertion rated with the BORG CR10 scale at the end of the 6 min walk
Measured: Day 3 at 2048 m
Severe hypoxemia
Number of participants in whom arterial oxygen saturation measured by pulse oximetry is less than 75% for more than 30 min during the oxygen and sham oxygen treatment periods at 2028 m.
Measured: Day 1 to 3 at 2048 m
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startMay 2014
- Primary completion31 Oct 2014
- Study completion31 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Konrad E Bloch, MD, Study chair, University Hospital, Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143609
- Sponsor's protocol ID
- 2013-0088V2A3
- Status last verified
- May 2019
- First submitted
- 18 May 2014
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients With Chronic Obstructive Pulmonary Disease at Altitude - Effect of Nocturnal Oxygen Therapy on Exercise Performance
- ClinicalTrials.gov ID
- NCT02143609
- Acronym / sponsor ID
- 2013-0088V2A3
- Keywords
- airway disease, bronchitis, emphysema, lung
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- 31 Oct 2014 (actual)
- Study completion
- 31 Oct 2014 (actual)
- First posted
- 21 May 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 purpose of this study is to investigate the effect of nocturnal oxygen therapy during a stay at moderate altitude on exercise performance of patients with chronic obstructive lung disease.
Detailed description
Patients with moderate to severe COPD living below 800 m, will be recruited to participate in a randomized cross-over field trial evaluating the hypothesis that exercise capacity during a 2 day sojourn at moderate altitude is improved by nocturnal oxygen therapy via a nasal cannula. Outcomes will be assessed during 2 days in Zurich (490 m, low altitude baseline), and during 2 days at St. Moritz Salastrains (2048 m).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxygen | Active comparator | Drug: oxygen, Drug: sham oxygen (room air)oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m |
| Sham oxygen | Placebo comparator | Drug: oxygen, Drug: sham oxygen (room air)sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- chronic obstructive pulmonary disease (COPD), GOLD grade 2-3
- residents at low altitude (<800 m)
Key exclusion criteria (11 listed)
- unstable condition, COPD exacerbation
- mild (GOLD 1) or very severe COPD (GOLD 4)
- requirement for oxygen therapy at low altitude residence
- hypoventilation
- pulmonary hypertension
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 |
|---|---|---|
| oxygenAlso: Nocturnal oxygen via nasal cannula, 3 L/min, at 2048 mNocturnal nasal oxygen during stay at 2048 m | Drug | Oxygen, Sham oxygen |
| sham oxygen (room air)Also: Nocturnal nasal room air during stay at 2048 mSham oxygen (room air) via nasal cannula, 3 L/min, at 2048 m | Drug | Oxygen, Sham oxygen |
Primary outcome
6 min walk distance
Time frame: Day 2 at 2048 m
Difference in the distance walked in 6 min between the oxygen and sham oxygen period
6 secondary outcomes
6 min walk distance
Time frame: day 3 at 2048 m
Arterial blood gas analysis
Time frame: Day 2 at 2048 m
Spirometry
Time frame: Day 2 at 2048 m
Perceived exertion
Time frame: Day 2 at 2048 m
Perceived exertion
Time frame: Day 3 at 2048 m
Severe hypoxemia
Time frame: Day 1 to 3 at 2048 m
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 14 May 2019.
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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.
Konrad E Bloch, MD study chair
University Hospital, Zürich
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 oxygen in people with Chronic Obstructive Pulmonary Disease (COPD), run by University of Zurich at 1 site in Switzerland.
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 11 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 14 May 2019. 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 Switzerland. 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 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?
6 min walk distance (time frame: Day 2 at 2048 m). 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 14 May 2019.