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

NCT02143609 | Completed Phase 4

• 1 other identifier: 2013-0088V2A3
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

airway disease; bronchitis; emphysema; lung

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 6 min walk distance

  day 3 at 2048 m

• Arterial blood gas analysis

  Day 2 at 2048 m

• Spirometry

  Day 2 at 2048 m

• Perceived exertion

  Day 2 at 2048 m

• Perceived exertion

  Day 3 at 2048 m

Study Arms (2)

Oxygen

ACTIVE COMPARATOR

oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m

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

Drug: oxygen; Drug: sham oxygen (room air)

Interventions

oxygen DRUG

Nocturnal nasal oxygen during stay at 2048 m

Also known as: Nocturnal oxygen via nasal cannula, 3 L/min, at 2048 m

Oxygen; Sham oxygen

sham oxygen (room air) DRUG

Sham oxygen (room air) via nasal cannula, 3 L/min, at 2048 m

Also known as: Nocturnal nasal room air during stay at 2048 m

Oxygen; Sham oxygen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Pulmonary Division

Zurich, CH-8091, Switzerland

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis; Emphysema

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Bronchial Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Konrad E Bloch, MD

  University Hospital, Zürich

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2014
• First Posted: May 21, 2014
• Study Start: May 1, 2014
• Primary Completion: October 31, 2014
• Study Completion: October 31, 2014
• Last Updated: May 14, 2019

Record last verified: 2019-05

Locations

CH (1)