NCT02848391

Brief Summary

Aim of this study was to evaluate the hypoxic response during hypobaric flight simulation in normal individuals as well as in normocapnic and hypercapnic COPD patients as well as to evaluate the impact of a flight simulation on walking endurance in these patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 28, 2016

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

March 1, 2018

Status Verified

February 1, 2018

Enrollment Period

3.6 years

First QC Date

June 24, 2016

Last Update Submit

February 28, 2018

Conditions

COPDHypoxiaAviation

Outcome Measures

Primary Outcomes (1)

  • Change in six minute walking distance measured in meters

    difference between pre- and post-flight walking distance

    30 Minutes before and after a 3 hour simulated flight (Time point - 30 and + 210 minutes)

Secondary Outcomes (1)

  • minimal Oxygen saturation measured by pulse oxymetry in %

    measurement completed at 180 minutes

Study Arms (3)

healthy subjects

EXPERIMENTAL

three hour flight simulation

Other: Environmental

COPD normocapnic

EXPERIMENTAL

three hour flight simulation

Other: Environmental

COPD hypercapnic

EXPERIMENTAL

three hour flight simulation

Other: Environmental

Interventions

EnvironmentalOTHER

hypobaric flight simulation

COPD hypercapnicCOPD normocapnichealthy subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No lung disease
  • COPD without hypercapnea
  • COPD with hypercapnea

You may not qualify if:

  • Claustrophobia
  • Renal insufficiency
  • Heart failure (ejection fraction \< 45 %)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kloster Grafschaft

Schmallenberg, North Rhine-Westphalia, 57392, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveHypoxia

Interventions

Environment

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and Symptoms

Intervention Hierarchy (Ancestors)

Ecological and Environmental PhenomenaBiological PhenomenaEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med

Study Record Dates

First Submitted

June 24, 2016

First Posted

July 28, 2016

Study Start

January 1, 2013

Primary Completion

August 1, 2016

Study Completion

September 1, 2017

Last Updated

March 1, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)