NCT01569880

Brief Summary

The purpose of the study is to investigate the relationship between hypoxemia achieved during Hypoxia Altitude Simulation test and sea level values of pulmonary function, arterial blood gases, pulse oximetry and cardiopulmonary exercise test variables. In addition, to study the effect of slow walk in a hypoxic environment, comparable to slow walking along the aisle.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2006

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 3, 2012

Completed
Last Updated

April 3, 2012

Status Verified

March 1, 2012

Enrollment Period

2.9 years

First QC Date

March 30, 2012

Last Update Submit

March 30, 2012

Conditions

Cystic Fibrosis

Keywords

Blood gas responseExerciseGas exchangeHypoxia altitude simulation testPulmonary function

Eligibility Criteria

Age17 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with cystic fibrosis

You may qualify if:

  • Cystic fibrosis
  • \> 16 years
  • Sputum test negative for Burkholderia cepacia and/or methicillin resistant Staphylococcus aureus

You may not qualify if:

  • Ongoing infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital, Ullevål

Oslo, 0450, Norway

Location

Related Publications (1)

  • Edvardsen E, Akero A, Skjonsberg OH, Skrede B. Pre-flight evaluation of adult patients with cystic fibrosis: a cross-sectional study. BMC Res Notes. 2017 Feb 6;10(1):84. doi: 10.1186/s13104-017-2386-2.

    PMID: 28166839DERIVED

MeSH Terms

Conditions

Cystic FibrosisMotor Activity

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesBehavior

Study Officials

  • Bjørn Skrede, PhD MD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2012

First Posted

April 3, 2012

Study Start

January 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

April 3, 2012

Record last verified: 2012-03

Locations

NO(1)