Patients With Chronic Obstructive Pulmonary Disease At Altitude

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

Effect of Altitude on Exercise Performance of Patients With Chronic Obstructive Lung Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01875133
• Other study ID #: 2013-0088
• Status: Completed
• Phase: N/A
• First received: May 29, 2013
• Last updated: May 18, 2015
• Start date: May 2013
• Est. completion date: December 2013

Study information

• Verified date: May 2015
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• altitude exposure
stay at different altitudes: 490, 1630, 2590 m

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Pulmonary Division	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in exercise performance from baseline measured at 490 m	6 min walk distance	Change in 6 min walk distance from 490 m baseline during 2 days at 2590 m	No
Secondary	Change in exercise performance from baseline measured at 490 m	6 min walk distance	Change in 6 min walk distance from 490 m baseline during 2 days at 1650 m	No
Secondary	Change in pulmonary function from baseline measured at 490 m	lung volumes by spirometry	Change in pulmonary function from 490 m baseline during 2 days at 2590 m	No
Secondary	Change in pulmonary function from baseline measured at 490 m	lung volumes by spirometry	Change in pulmonary function from 490 m baseline during 2 days at 1650 m	No
Secondary	Change in arterial blood gases from baseline measured at 490 m	Arterial blood gas analysis	Change in arterial blood gases from 490 m baseline during 2 days at 2590 m	No
Secondary	Change in arterial blood gases from baseline measured at 490 m	Arterial blood gas analysis	Change in arterial blood gases from 490 m baseline during 2 days at 1650 m	No
Secondary	Change in perceived exertion from baseline measured at 490 m	Borg CR10 scale at end of 6 min walk	Change in perceived exertion from 490 m baseline during 2 days at 2590 m	No
Secondary	Change in perceived exertion from baseline measured at 490 m	Borg CR10 scale at end of 6 min walk	Change in perceived exertion from 490 m baseline during 2 days at 1650 m	No