Patients With Chronic Obstructive Pulmonary Disease at Altitude - Effect of Nocturnal Oxygen on Exercise Performance

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

Patients With Chronic Obstructive Pulmonary Disease at Altitude - Effect of Nocturnal Oxygen Therapy on Exercise Performance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02143609
• Other study ID #: 2013-0088V2A3
• Status: Completed
• Phase: Phase 4
• Start date: May 2014
• Est. completion date: October 31, 2014

Study information

• Verified date: May 2019
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 31, 2014
• Est. primary completion date: October 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• 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

Related Conditions & MeSH terms

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

Intervention

Drug:
• oxygen
Nocturnal nasal oxygen during stay at 2048 m
• sham oxygen (room air)
Sham oxygen (room air) via nasal cannula, 3 L/min, at 2048 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	6 min walk distance	Difference in the distance walked in 6 min between the oxygen and sham oxygen period	Day 2 at 2048 m
Secondary	6 min walk distance	Difference in the distance walked in 6 min between the oxygen and sham oxygen period	day 3 at 2048 m
Secondary	Arterial blood gas analysis	Difference in arterial oxygen partial pressure, carbon dioxide partial pressure, and pH	Day 2 at 2048 m
Secondary	Spirometry	Difference in spirometric variables between the oxygen and sham oxygen period	Day 2 at 2048 m
Secondary	Perceived exertion	Difference in perceived exertion rated with the BORG CR10 scale at the end of the 6 min walk	Day 2 at 2048 m
Secondary	Perceived exertion	Difference in perceived exertion rated with the BORG CR10 scale at the end of the 6 min walk	Day 3 at 2048 m
Secondary	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.	Day 1 to 3 at 2048 m