Patients With Chronic Obstructive Pulmonary Disease At Altitude

NCT01875133 | Completed

• 1 other identifier: 2013-0088
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

airway disease; bronchitis; emphysema; lung

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Change in exercise performance from baseline measured at 490 m

  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

  Change in pulmonary function from 490 m baseline during 2 days at 2590 m

• Change in pulmonary function from baseline measured at 490 m

  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

  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

  Change in arterial blood gases from 490 m baseline during 2 days at 1650 m

Study Arms (4)

A: low-intermediate-high altitude

OTHER

Altitude exposure sequence A, 490-1630-2590m

Other: altitude exposure

B: low-high-intermediate altitude

OTHER

Altitude exposure sequence B, 490-2590-1630 m

Other: altitude exposure

C: intermediate-high-low altitude

OTHER

Altitude exposure sequence C, 1630-2590-490 m

Other: altitude exposure

D: high-intermediate-low altitude

OTHER

Altitude exposure sequence D, 2590-1630-490 m

Other: altitude exposure

Interventions

altitude exposure OTHER

stay at different altitudes: 490, 1630, 2590 m

A: low-intermediate-high altitude; B: low-high-intermediate altitude; C: intermediate-high-low altitude; D: high-intermediate-low altitude

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

Related Publications (2)

• 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.

  PMID: 30936690 DERIVED

• 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.

  PMID: 30464436 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis; Emphysema

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

Study Officials

• Konrad E Bloch, MD

  University Hospital, Zürich

  STUDY CHAIR

• Tsogyal D Latshang, MD

  University Hospital, Zürich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2013
• First Posted: June 11, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 19, 2015

Record last verified: 2015-05

Locations

CH (1)