Pre-flight Evaluation of Adult Patients With Cystic Fibrosis | NCT01569880

Studies
Pre-flight Evaluation of Adult Patients With Cystic Fibrosis

NCT01569880

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Apr 3, 2012Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

Cystic Fibrosis

Interventions

Not provided

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Mar 30, 2012

First Submission Date that Met QC Criteria

Mar 30, 2012

First Posted Date

Apr 3, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2012

Last Update Posted Date

Apr 3, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Ongoing infection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Adult patients with cystic fibrosis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bjørn Skrede, PhD MD	Oslo University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo University Hospital, Ullevål		Oslo		0450	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28166839	Derived	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.

ID	Term
D003550	Cystic Fibrosis
D009043	Motor Activity

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases