OSCILLOPOUMON: Forced Oscillation Versus Spirometry in Diagnosing Post Pulmonary Transplant Bronchiolitis Obliterans Syndrome

• Sponsor: Hopital Foch (Other)
• Overall Status: Completed
• CT.gov ID: NCT01807975
• Collaborator: (none)
• Enrollment: 110
• Location: 1
• Arm: 1
• Duration (Months): 48
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Bronchiolitis Obliterans Syndrome	Other: Forced oscillation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 110 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: post allogreffe patients 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

Outcome Measures

Primary Outcome Measures

1. Time difference in diagnosing distal airways functional disturbance by forced oscillation and by spirometry (standard methode). [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients of more than 18 year-old.

• Patients with cardiopulmonary transplant or bilateral lung transplant.

• Clinically stable patients

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital FOCH	Suresnes	Ile de France	France	92150

Sponsors and Collaborators

• Hopital Foch

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hopital Foch
• ClinicalTrials.gov Identifier: NCT01807975
• Other Study ID Numbers: 2010/56
• First Posted: Mar 8, 2013
• Last Update Posted: Jul 28, 2016
• Last Verified: May 1, 2016

• Additional relevant MeSH terms: Bronchiolitis; Bronchiolitis Obliterans; Syndrome

Study Results

No Results Posted as of Jul 28, 2016