Patients With Chronic Obstructive Pulmonary Disease At Altitude

NCT ID: NCT01875133

Last Updated: 2015-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2013-12-31

Brief 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.

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

A: low-intermediate-high altitude

Altitude exposure sequence A, 490-1630-2590m

Group Type: OTHER

altitude exposure

Intervention Type: OTHER

stay at different altitudes: 490, 1630, 2590 m

B: low-high-intermediate altitude

Altitude exposure sequence B, 490-2590-1630 m

Group Type: OTHER

altitude exposure

Intervention Type: OTHER

stay at different altitudes: 490, 1630, 2590 m

C: intermediate-high-low altitude

Altitude exposure sequence C, 1630-2590-490 m

Group Type: OTHER

altitude exposure

Intervention Type: OTHER

stay at different altitudes: 490, 1630, 2590 m

D: high-intermediate-low altitude

Altitude exposure sequence D, 2590-1630-490 m

Group Type: OTHER

altitude exposure

Intervention Type: OTHER

stay at different altitudes: 490, 1630, 2590 m

Interventions

altitude exposure

stay at different altitudes: 490, 1630, 2590 m

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• chronic obstructive pulmonary disease (COPD), GOLD grade 2-3
• residents at low altitude (<800 m)

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Konrad E Bloch, MD

Role: STUDY_CHAIR

University Hospital, Zürich

Tsogyal D Latshang, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Zürich

Locations

University Hospital Zurich, Pulmonary Division

Zurich, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 30936690 (View on PubMed)

Furian 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.

Reference Type: DERIVED

PMID: 30464436 (View on PubMed)

Other Identifiers

2013-0088

Identifier Type: -

Identifier Source: org_study_id