Time to Perform Lung Function Test in Cystic Fibrosis | NCT01737801

Studies
Time to Perform Lung Function Test in Cystic Fibrosis

NCT01737801

Sponsor

Karolinska University Hospital

Status

Completed

Last Update Posted

Nov 30, 2012Estimated

Enrollment

24Actual

Phase

Not Applicable

Conditions

Cystic Fibrosis

Interventions

Lung function test

Countries

Sweden

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

Nov 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

Feb 2008

Primary Completion Date

Jan 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Nov 19, 2012

First Submission Date that Met QC Criteria

Nov 29, 2012

First Posted Date

Nov 30, 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

Nov 29, 2012

Last Update Posted Date

Nov 30, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Cecilia Rodriguez, Physiotherapist, Karolinska University HospitalPrincipal Investigator

Lead Sponsor

Karolinska University HospitalOTHER

Collaborators

Not provided

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

Time to perform lung function test after chest physiotherapy in cystic fibrosis.

The investigators study FEV1(forced expiratory volume in one second) and FVC (forced vital capacity).

Detailed Description

The patients perform spirometry before, direct after, 30 minutes, 1 hour, 2 hours, and 3 hours after physiotherapist. The investigators want to study the FEV1 and FVC.

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lung function test	Experimental	Lung function test	Procedure: Lung function test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lung function test	Procedure	Lung function test.	Lung function test

Measure	Description	Time Frame
Lung function test. FEV1 and FVC		2 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with cystic fibrosis

Exclusion Criteria:

patients with cystic fibrosis who could not stay at the clinic for more than 4 hrs.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cecilia Rodriguez, Physio	Karolinska Institutet	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karolinska University Hospital		Stockholm	Stockholm County		Sweden

Condition Browse Module

MeSH Terms

ID	Term
D003550	Cystic Fibrosis

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012143	Respiratory Physiological Phenomena

Ancestor Terms

ID	Term
D002943	Circulatory and Respiratory Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided