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Respiratory Impedance and Obliterative Bronchiolitis (FOT-BOS)

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ClinicalTrials.gov Identifier: NCT01255449
Recruitment Status : Completed
First Posted : December 7, 2010
Results First Posted : January 31, 2013
Last Update Posted : January 31, 2013
Sponsor:
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
Enrollment 26
Recruitment Details 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 All patients were in stable clinical conditions and none had a history of significant respiratory disease.
Arm/Group Title Albuterol
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 26
Completed 26
Not Completed 0
Arm/Group Title Albuterol
Hide Arm/Group Description All recruited subjects underwent an acute bronchodilation with albuterol following baseline pulmonary function measurements.
Overall Number of Baseline Participants 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
<=18 years
2
   7.7%
Between 18 and 65 years
24
  92.3%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants
37  (14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Female
9
  34.6%
Male
17
  65.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Italy Number Analyzed 26 participants
26
1.Primary Outcome
Title Airway Distensibility With Lung Inflation After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Hide Description We studied 26 subjects, 2 weeks before and 2 months after HSCT. Within-breath respiratory system conductance (Grs) at 5, 11 and 19 Hz was measured by forced oscillation technique (FOT) at functional residual capacity (FRC) and total lung capacity (TLC)
Time Frame 2 weeks before and 2 months after HSCT
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Airway Distensibility With Lung Inflation After HSCT
Hide Arm/Group Description:
Changes in airway conductance at 5 Hz (Grs5) were related to changes in lung volume (DeltaGrs5/DeltaVL) to estimate airway distensibility
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: 1/cmH2O*s
0.07  (0.10)
2.Secondary Outcome
Title Post-HSCT Changes in Lung Tissue Density
Hide Description Changes in lung tissue density were measured by quantitative computed tomography(CT) scan 2 weeks before and 2 months after HSCT
Time Frame Before and 2 months after HSCT
Hide Outcome Measure Data
Hide Analysis Population Description
CT scans, in a format suitable for software analysis, were available in 8 patients only
Arm/Group Title Post-HSCT Changes in Lung Tissue Density
Hide Arm/Group Description:
In eight out of 26 patients, a quantitative CT scan analysis was conducted to measure changes in lung tissue density
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: g/mL
0.03  (0.02)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Albuterol
Hide Arm/Group Description All subjects underwent an acute bronchodilation with albuterol by inhaling four consecutive doses (100 mcg each)of the drug through a valved-holding chamber
All-Cause Mortality
Albuterol
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Albuterol
Affected / at Risk (%)
Total   0/26 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Albuterol
Affected / at Risk (%)
Total   0/26 (0.00%) 
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
Other Publications:
Responsible Party: Giovanni Barisione, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
ClinicalTrials.gov 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