Respiratory Impedance and Obliterative Bronchiolitis (FOT-BOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01255449
Recruitment Status : Completed
First Posted : December 7, 2010
Results First Posted : January 31, 2013
Last Update Posted : January 31, 2013
Information provided by (Responsible Party):
Giovanni Barisione, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions: Hematopoietic Stem Cell Transplantation
Obliterative Bronchiolitis
Intervention: Drug: albuterol

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The recruitment started on 10-Nov-2010 and finished on 15-feb-2012. The recruitment was performed at Pulmonary Function Tests Laboratory of IRCCS AOU San Martino.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All patients were in stable clinical conditions and none had a history of significant respiratory disease.

Reporting Groups
Albuterol On each study day, all lung function measurements were taken before and 30 min after inhaling four consecutive albuterol doses of 100 mcg each, through a valved-holding chamber. Lung diffusing capacity for carbon monoxide was measured only after bronchodilator inhalation.

Participant Flow:   Overall Study

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Albuterol All recruited subjects underwent an acute bronchodilation with albuterol following baseline pulmonary function measurements.

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   2 
Between 18 and 65 years   24 
>=65 years   0 
[Units: Years]
Mean (Standard Deviation)
 37  (14) 
[Units: Participants]
Female   9 
Male   17 
Region of Enrollment 
[Units: Participants]
Italy   26 

  Outcome Measures

1.  Primary:   Airway Distensibility With Lung Inflation After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)   [ Time Frame: 2 weeks before and 2 months after HSCT ]

2.  Secondary:   Post-HSCT Changes in Lung Tissue Density   [ Time Frame: Before and 2 months after HSCT ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Dr. Giovanni Barisione
Organization: IRCCS Azienda Ospedaliera Universitaria San Martino IST - Genova, Italy
phone: +39010555 ext 3367

Publications of Results:
Other Publications:

Responsible Party: Giovanni Barisione, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy Identifier: NCT01255449     History of Changes
Other Study ID Numbers: FOT-BOS-01
First Submitted: December 6, 2010
First Posted: December 7, 2010
Results First Submitted: September 18, 2012
Results First Posted: January 31, 2013
Last Update Posted: January 31, 2013