Chronic Obstructive Pulmonary Disease (COPD)NCT01875133
Patients With Chronic Obstructive Pulmonary Disease At Altitude
A study testing altitude exposure 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 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?
- altitude exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2013to Dec 2013
- 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 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
Show all 11Show fewer
- 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: Effect of Altitude on Exercise Performance of Patients With Chronic Obstructive Lung Disease
The purpose of this study is to investigate the effect of 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 4 day sojourn at moderate altitude is reduced in comparison to low altitude. Outcomes will be assessed during 2 days in Zurich (490 m, low altitude baseline), 2 days at Davos Clavadel (1650 m), and 2 days at Davos Jakobshorn (2590 m). The main outcome is the 6 minute walk distance.
- Being tested
- altitude exposure
- 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.
altitude exposureOther
stay at different altitudes: 490, 1630, 2590 m
| Study group | Role | What they receive |
|---|---|---|
| A: low-intermediate-high altitude | Other | Altitude exposure sequence A, 490-1630-2590m Receives: Other: altitude exposure |
| B: low-high-intermediate altitude | Other | Altitude exposure sequence B, 490-2590-1630 m Receives: Other: altitude exposure |
| C: intermediate-high-low altitude | Other | Altitude exposure sequence C, 1630-2590-490 m Receives: Other: altitude exposure |
| D: high-intermediate-low altitude | Other | Altitude exposure sequence D, 2590-1630-490 m Receives: Other: altitude exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in exercise performance from baseline measured at 490 m
6 min walk distance
Measured: Change in 6 min walk distance from 490 m baseline during 2 days at 2590 m
Secondary outcomes (7)
Change in exercise performance from baseline measured at 490 m
6 min walk distance
Measured: Change in 6 min walk distance from 490 m baseline during 2 days at 1650 m
Change in pulmonary function from baseline measured at 490 m
lung volumes by spirometry
Measured: Change in pulmonary function from 490 m baseline during 2 days at 2590 m
Change in pulmonary function from baseline measured at 490 m
lung volumes by spirometry
Measured: Change in pulmonary function from 490 m baseline during 2 days at 1650 m
Change in arterial blood gases from baseline measured at 490 m
Arterial blood gas analysis
Measured: Change in arterial blood gases from 490 m baseline during 2 days at 2590 m
Change in arterial blood gases from baseline measured at 490 m
Arterial blood gas analysis
Measured: Change in arterial blood gases from 490 m baseline during 2 days at 1650 m
Change in perceived exertion from baseline measured at 490 m
Borg CR10 scale at end of 6 min walk
Measured: Change in perceived exertion from 490 m baseline during 2 days at 2590 m
Change in perceived exertion from baseline measured at 490 m
Borg CR10 scale at end of 6 min walk
Measured: Change in perceived exertion from 490 m baseline during 2 days at 1650 m
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
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, ZürichTsogyal D Latshang, MD, Principal investigator, University Hospital, Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875133
- Sponsor's protocol ID
- 2013-0088
- Status last verified
- May 2015
- First submitted
- 29 May 2013
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Schwarz EI, Latshang TD, Furian M, Fluck D, Segitz S, Muller-Mottet S, Ulrich S, Bloch KE, Kohler M. Blood pressure response to exposure to moderate altitude in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2019 Mar 14;14:659-666. doi: 10.2147/COPD.S194426. eCollection 2019.
PubMed 30936690Furian M, Flueck D, Latshang TD, Scheiwiller PM, Segitz SD, Mueller-Mottet S, Murer C, Steiner A, Ulrich S, Rothe T, Kohler M, Bloch KE. Exercise performance and symptoms in lowlanders with COPD ascending to moderate altitude: randomized trial. Int J Chron Obstruct Pulmon Dis. 2018 Oct 26;13:3529-3538. doi: 10.2147/COPD.S173039. eCollection 2018.
PubMed 30464436
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Altitude on Exercise Performance of Patients With Chronic Obstructive Lung Disease
- ClinicalTrials.gov ID
- NCT01875133
- Acronym / sponsor ID
- 2013-0088
- Keywords
- airway disease, bronchitis, emphysema, lung
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Jun 2013 (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 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 4 day sojourn at moderate altitude is reduced in comparison to low altitude. Outcomes will be assessed during 2 days in Zurich (490 m, low altitude baseline), 2 days at Davos Clavadel (1650 m), and 2 days at Davos Jakobshorn (2590 m). The main outcome is the 6 minute walk distance.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A: low-intermediate-high altitude | Other | Other: altitude exposureAltitude exposure sequence A, 490-1630-2590m |
| B: low-high-intermediate altitude | Other | Other: altitude exposureAltitude exposure sequence B, 490-2590-1630 m |
| C: intermediate-high-low altitude | Other | Other: altitude exposureAltitude exposure sequence C, 1630-2590-490 m |
| D: high-intermediate-low altitude | Other | Other: altitude exposureAltitude exposure sequence D, 2590-1630-490 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 |
|---|---|---|
| altitude exposurestay at different altitudes: 490, 1630, 2590 m | Other | A: low-intermediate-high altitude, B: low-high-intermediate altitude, C: intermediate-high-low altitude, D: high-intermediate-low altitude |
Primary outcome
Change in exercise performance from baseline measured at 490 m
Time frame: Change in 6 min walk distance from 490 m baseline during 2 days at 2590 m
6 min walk distance
7 secondary outcomes
Change in exercise performance from baseline measured at 490 m
Time frame: Change in 6 min walk distance from 490 m baseline during 2 days at 1650 m
Change in pulmonary function from baseline measured at 490 m
Time frame: Change in pulmonary function from 490 m baseline during 2 days at 2590 m
Change in pulmonary function from baseline measured at 490 m
Time frame: Change in pulmonary function from 490 m baseline during 2 days at 1650 m
Change in arterial blood gases from baseline measured at 490 m
Time frame: Change in arterial blood gases from 490 m baseline during 2 days at 2590 m
Change in arterial blood gases from baseline measured at 490 m
Time frame: Change in arterial blood gases from 490 m baseline during 2 days at 1650 m
Change in perceived exertion from baseline measured at 490 m
Time frame: Change in perceived exertion from 490 m baseline during 2 days at 2590 m
Change in perceived exertion from baseline measured at 490 m
Time frame: Change in perceived exertion from 490 m baseline during 2 days at 1650 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 19 May 2015.
- Derived from this study: PubMed 30936690Schwarz EI, Latshang TD, Furian M, Fluck D, Segitz S, Muller-Mottet S, Ulrich S, Bloch KE, Kohler M. Blood pressure response to exposure to moderate altitude in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2019 Mar 14;14:659-666. doi: 10.2147/COPD.S194426. eCollection 2019.
- Derived from this study: PubMed 30464436Furian M, Flueck D, Latshang TD, Scheiwiller PM, Segitz SD, Mueller-Mottet S, Murer C, Steiner A, Ulrich S, Rothe T, Kohler M, Bloch KE. Exercise performance and symptoms in lowlanders with COPD ascending to moderate altitude: randomized trial. Int J Chron Obstruct Pulmon Dis. 2018 Oct 26;13:3529-3538. doi: 10.2147/COPD.S173039. eCollection 2018.
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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
Tsogyal D Latshang, MD principal investigator
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 study testing altitude exposure 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 19 May 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 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. 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?
Change in exercise performance from baseline measured at 490 m (time frame: Change in 6 min walk distance from 490 m baseline during 2 days at 2590 m). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01875133, which also lists 2 linked publications.
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 19 May 2015; AzTrials last refreshed its copy on 6 Nov 2026.