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

Bronchiolitis Obliterans Syndrome Clinical Trial

— OSCILLOPOUMON  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01807975
• Other study ID #: 2010/56
• Status: Completed
• Phase: N/A
• First received: March 7, 2013
• Last updated: July 27, 2016
• Start date: September 2011
• Est. completion date: September 2015

Study information

• Verified date: May 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bronchiolitis
• Bronchiolitis Obliterans
• Bronchiolitis Obliterans Syndrome
• Syndrome

Intervention

Other:
• Forced oscillation

Locations

Country	Name	City	State
France	Hôpital FOCH	Suresnes	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time difference in diagnosing distal airways functional disturbance by forced oscillation and by spirometry (standard methode).		2 years	No