NCT01807975

Brief Summary

A study to evaluate the role of forced oscillation in precocious diagnosis of bronchiolitis obliterans syndrome in patients with pulmonary transplant (time difference in detecting distal airways functional impairment by forced oscillation and the standard technique using spirometry).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2011

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 8, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

July 28, 2016

Status Verified

May 1, 2016

Enrollment Period

4 years

First QC Date

March 7, 2013

Last Update Submit

July 27, 2016

Conditions

Bronchiolitis Obliterans Syndrome

Outcome Measures

Primary Outcomes (1)

  • Time difference in diagnosing distal airways functional disturbance by forced oscillation and by spirometry (standard methode).

    2 years

Study Arms (1)

post allogreffe patients

EXPERIMENTAL

Functional evaluation of distal airway by forced oscillation technique : relevance earlier diagnostic of pulmonary syndrom of oblitérant bronchiolit in post allogreffe patients

Other: Forced oscillation

Interventions

Forced oscillationOTHER
post allogreffe patients

Eligibility Criteria

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

You may qualify if:

  • Patients of more than 18 year-old.
  • Patients with cardiopulmonary transplant or bilateral lung transplant.
  • Clinically stable patients

You may not qualify if:

  • Patients already diagnosed with bronchiolitis obliterans.
  • Respiratory infection.
  • Acute graft rejection.
  • Mechanical complications (bronchial dehiscence, pneumothorax, pleural effusion).
  • Iatrogenic pneumopathy.
  • Inability to perform Respiratory function test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital FOCH

Suresnes, Île-de-France Region, 92150, France

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Organizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2013

First Posted

March 8, 2013

Study Start

September 1, 2011

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

July 28, 2016

Record last verified: 2016-05

Locations

FR(1)